Multi-Modal Analgesic Technique for Pain Control in Patients Undergoing Diagnostic Gynecological Laparoscopy: Randomized Controlled Clinical Trial

BACKGROUND: Advancement in minimally invasive laparoscopic surgeries make it one of the best choices for both the surgeon and the patient. The anesthesiologist had to improve the techniques used to control post-operative pain. AIM: In this study, we hyposethized that multi-modal analgesic technique which is a combination of two simple techniques (intraperitoneal lidocaine and pulmonary recruitment) allow better result than using only one of them. PATIENTS AND METHOD: This randomised controlled, double-blind study was conducted in Kasr-Alainy hospital, faculty of medicine, Cairo University, Egypt from September 2017 till February 2018. Fifty female patients, scheduled for diagnostic gynecologic laparoscopy were included in the study. Patients were randomly allocated using random computer allocation with numbered closed opaque envelopes into four study group. GM (n = 12): Patients received pulmonary recruitment maneuver and intra-peritoneal Lidocaine, GL (n = 13): Patients received intra-peritoneal Lidocaine, GP (n = 13): Patients received Pulmonary Recruitment Maneuver, GC (n = 12): Patients received passive exsufflation through the port site. In the ward, patients were asked to fulfil a questionnaire about pain severity using (VAS) at 1, 3, 6-hour post-operative both the patients and the anesthesiologist that assess the (VAS) were blind of the patient group RESULTS: Regarding pain score between groups VAS 1 (the primary outcome) was lowest in GM {4.5 (3-5)} in comparison with other groups (P value = 0.015). While VAS 3 & VAS 6 wasn’t statistically significant between groups. Regarding Time of first rescue analgesia; GM {3 (1.75-4)} showed the longest time in between groups (P-value = 0.042). As regard nausea and vomiting; there was no statistically significant difference in in-between groups. CONCLUSION: Application of Multi-modal analgesic technique allows better analgesia for a longer duration than the use of the sole technique for control of abdominal pain in patients undergoing diagnostic gynaecological laparoscopy.

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Duloxetine augmentation in resistant obsessive compulsive disorder: Surveying a new medication for challenges in treatment of OCD

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.361 ◽

2017 ◽

Vol 41 (S1) ◽

pp. S415-S415

Author(s):

A. Mowla

Keyword(s):

Obsessive Compulsive Disorder ◽

Primary Outcome Measure ◽

Controlled Clinical Trial ◽

Double Blind Study ◽

Obsessive Compulsive ◽

Double Blind ◽

Compulsive Disorder ◽

Significant Difference ◽

Competing Interest ◽

To Receive

IntroductionUp to 50% of patients with OCD have failed to respond in SSRI trials, so looking for pharmacological alternatives in treatment of obsessive compulsive disorder (OCD) seems necessary.ObjectivesSurveying duloxetine augmentation in treatment of resistant OCD.AimsStudy the effects of serotonin-norepinephrine enhancers for treatment of OCD.MethodsThis augmentation trial was designed as an 8-week randomized controlled, double blind study. Forty-six patients suffering from OCD who had failed to respond to at least 12 weeks of treatment with a selective serotonin reuptake inhibitor (fluoxetine, citalopram or fluvoxamine) were randomly allocated to receive duloxetine or sertraline plus their current anti OCD treatment. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) was the primary outcome measure.ResultsForty-six patients (24 of 30 in duloxetine group and 22 of 27 in sertraline group) completed the trial. Both groups showed improvement over the 8-week study period (mean Y-BOCS total score at week 8 as compared with baseline: P < 0.001 and P < 0.001) without significant difference (P = 0.861). Those receiving duloxetine plus their initial medications experienced a mean decrease of 33.0% in Y-BOCS score and the patients with sertraline added to their initial medication experienced a mean decrease of 34.5% in Y-BOCS.ConclusionsOur double blind controlled clinical trial showed duloxetine to be as effective as sertraline in reducing obsessive and compulsive symptoms in resistant OCD patients. However, it needs to be noted that our study is preliminary and larger double blind placebo controlled studies are necessary to confirm the results.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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A Multicenter, Prospective, Randomized, Placebo-Controlled, Double-Blind Study of a Novel Pain Management Device, AT-02, in Patients with Fibromyalgia

Pain Medicine ◽

10.1093/pm/pnz064 ◽

2019 ◽

Vol 21 (2) ◽

pp. 326-332 ◽

Cited By ~ 1

Author(s):

Hiroshi Oka ◽

Kenji Miki ◽

Iwao Kishita ◽

David F Kong ◽

Takahiro Uchida

Keyword(s):

Rating Scale ◽

Numerical Rating Scale ◽

Repeated Measure ◽

Controlled Clinical Trial ◽

Double Blind Study ◽

Double Blind ◽

Point Change ◽

Entire Treatment Period ◽

Magnetic Field Therapy ◽

Significant Difference

Abstract Objectives Existing treatments for fibromyalgia have limited efficacy, and only a minority of individuals clinically respond to any single intervention. This study was a prospective, multicenter, randomized, double-blind, controlled clinical trial to evaluate the feasibility of alternating magnetic field therapy in fibromyalgia patients by comparing the Angel Touch device (AT-02) with a sham control (S-01). Methods Two sites enrolled 44 subjects with diagnosed fibromyalgia. After informed consent, subjects taking prohibited concomitant drugs underwent a washout period of two or more weeks. All subjects then began a one-week run-in period. Numerical rating scale (NRS) pain scores were collected without device intervention for one day, followed by S-01 application to four or more painful sites for 10 minutes at each site, twice daily for six days. Subjects were then randomized to AT-02 or S-01, applied to four or more painful sites for 10 minutes at each site, twice daily for eight weeks. NRS scores were obtained twice daily during the entire treatment period. Results The primary end point (change in NRS ± SD at week 8 vs baseline) was –0.94 ± 1.33 in the AT-02 group and –0.22 ± 1.38 in the S-01 group. A trend toward a between-group difference in eight-week NRS scores favored the AT-02 group (–0.73, 95% confidence interval = –1.56 to 0.11, P = 0.086). An adjusted repeated measure analysis detected a significant difference in NRS scores (P = 0.039). Conclusions The reduction in NRS scores for AT-02 relative to sham was comparable to reductions observed in meta-analyses of fibromyalgia drug therapy. The unadjusted results and the persistence of the pain score reductions remain encouraging.

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Riluzole for treatment of men with methamphetamine dependence: A randomized, double-blind, placebo-controlled clinical trial

Journal of Psychopharmacology ◽

10.1177/0269881118817166 ◽

2018 ◽

Vol 33 (3) ◽

pp. 305-315 ◽

Cited By ~ 6

Author(s):

Mohammad-Hadi Farahzadi ◽

Ehsan Moazen-Zadeh ◽

Emran Razaghi ◽

Mohammad-Reza Zarrindast ◽

Reza Bidaki ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trials ◽

Specific Treatment ◽

Controlled Clinical Trial ◽

P Value ◽

Urine Test ◽

Double Blind ◽

Double Blind Placebo ◽

Methamphetamine Dependence ◽

Significant Difference

Background: Riluzole is a glutamate regulator and effective in treatment of neuropsychiatric conditions. Aims: We assessed riluzole for treatment of methamphetamine dependence. Methods: In this randomized, double-blind, placebo-controlled clinical trial, male outpatients with methamphetamine dependence who were 18–65 years old received either 50 mg riluzole ( n=34) or placebo ( n=54) twice daily for 12 weeks. Patients were excluded in case of comorbid serious medical conditions or neurologic disorders, comorbid psychiatric disorders other than methamphetamine dependence requiring specific treatment interventions, simultaneous positive urine test result for substances of abuse other than methamphetamine, smoking >3 days per week, simultaneous consumption of medications which are contraindicated or have interaction with riluzole. Results: Concerning primary outcomes, the cumulative mean number of attended weekly visits was higher in the riluzole arm compared with the placebo arm approaching a statistically significant difference (riluzole, median (range)=13.00 (2.00–13.00); placebo=4.00 (2.00–13.00); Mann-Whitney U=505.00, p-value=0.073), and the weekly measured rate of positive methamphetamine urine test results was significantly lower in the riluzole arm by the end of the study (riluzole=1 (5.00%), placebo=9 (45.00%), p-value=0.004). Patients in the riluzole arm experienced significantly greater improvement on all the craving, withdrawal, and depression measures regarding mean score changes from baseline to endpoint. No significant difference was detected between the two arms in terms of incidence of adverse events. Conclusion: Future randomized clinical trials are needed to investigate proper dosing strategy in a more inclusive sample.

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Analgesic Effect of Intraarticular Tramadol with Morphine after Arthroscopic Knee Surgery

Nepal Orthopaedic Association Journal ◽

10.3126/noaj.v3i1.9320 ◽

2013 ◽

Vol 3 (1) ◽

pp. 14-18

Author(s):

Hussain Faisal ◽

Arjun Lamichhane ◽

Deepak Mahara

Keyword(s):

Side Effects ◽

Arthroscopic Surgery ◽

Visual Analogue Score ◽

Work Load ◽

P Value ◽

Double Blind Study ◽

Morphine Group ◽

Double Blind ◽

Duration Of Symptoms ◽

Significant Difference

Introduction: Post-operative improved pain control of patients has made arthroscopy as a day care procedure, reducing patient’s expenses and hospital staffs work load. Various analgesic drugs have been administered into the joint following Arthroscopy. Intra-articular injection of morphine has been practiced in many centres all over the world. We aimed to compare the efficacy of intra-articular tramadol and morphine. Tramadol is an opioid drug with similar analgesic properties like morphine. Tramadol unlike morphine is readily available over the counter not being abused and has more favourable side effects. Methods: It was a prospectively randomized double-blind study in which sixty patients having elective arthroscopic surgery of the knee were randomized into two groups. Group A (Tramadol Group) received intra-articular tramadol 50mg and Group B (Morphine Group) received morphine 5mg in equivalent volumes. Post-operative pain using Visual Analogue Score (VAS) between 0 and 10, (0 no pain to 10 worst pain) requirement of first analgesic, and incidence of side effects were recorded postoperatively at intervals of 3,4,5,6 and 24 hours. Results: The assessment of VAS score among the two groups in 3,4,5,6 and 24 hours of IA injection showed a p value of 0.349, 0.807, 0.676, 0.271 and 0.163 respectively, suggesting non significant difference in two groups. There was statistically significant result (p=0.005) for request of first analgesia (Ibuprofen 400mg+ Paracetalmol 500mg) at 6 hours of IA injection with tramadol group, requiring less analgesics. There are no other clinically important differences between the groups, including preoperative duration of symptoms, postoperative pain scores and side effects irrespective of the diagnosis and the procedure performed. Conclusion: 50 mg IA tramadol provides analgesia equivalent to 5 mg IA morphine. DOI: http://dx.doi.org/10.3126/noaj.v3i1.9320 Nepal Orthopedic Association Journal 2013 Vol.3(1): 14-18

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The Effectiveness of 5% Tea Tree Oil cream, 10% Tea Tree Oil cream, and 5% Permethrin Cream for Scabies Treatment in Pediatric Patients

Berkala Ilmu Kesehatan Kulit dan Kelamin ◽

10.20473/bikk.v32.3.2020.200-205 ◽

2020 ◽

Vol 32 (3) ◽

pp. 200

Author(s):

Chesia Christiani Liuwan ◽

Muhammad Yulianto Listiawan ◽

Dwi Murtiastutik ◽

Evy Ervianti ◽

Sawitri Sawitri ◽

...

Keyword(s):

Pediatric Patients ◽

Skin Diseases ◽

Sarcoptes Scabiei ◽

Controlled Clinical Trial ◽

P Value ◽

Tea Tree Oil ◽

Cure Rate ◽

Double Blind ◽

Tea Tree ◽

Significant Difference

Background: Scabies, an infectious disease caused by Sarcoptes scabiei mites, is still one of the most common skin diseases found in developing countries, including Indonesia. The 5% permethrin cream for scabies treatment has been investigated as having 2–3 time to cure scabies. Tea Tree Oil (TTO) is one of the agents that has been proven to have acaricidal potential as an anti-inflammatory, antibacterial, and antipruritic agent. It has minimal side effects in topical use. Purpose: To evaluate the effectiveness of 5% TTO cream and 10% TTO cream in scabies treatment of pediatric patients. Methods: This was an experimental, analytical study with controlled clinical trial methods, and a double-blind, parallel design comparing 5% TTO cream (treatment 1), 10% TTO cream (treatment 2), with 5% permethrin cream (control) to children with scabies. Result: The 5% TTO cream gave a cure rate of 61.5% and was significantly different from the 5% permethrin cream groups with a p-value = 0.044 in the first week of the study. The 5% permethrin cream gave a cure rate of 15.4%, and the cure rate of 10% TTO cream was 53.8% in the first week of the study. Conclusion: There was a significant difference between the 5% TTO cream and 5% permethrin cream in the first week of the study. The highest and fastest cure rates were found in the 5% TTO cream treatment group.

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EFFECTS OF THREE ORAL ANALGESICS ON POSTOPERATIVE PAIN FOLLOWING ROOT CANAL PREPARATION: A CONTROLLED CLINICAL TRIAL

Pakistan Armed Forces Medical Journal ◽

10.51253/pafmj.v71i2.3391 ◽

2021 ◽

Vol 71 (2) ◽

pp. 526-29

Author(s):

Shahid Islam ◽

Muhammad Ali ◽

Abubakar Shaikh ◽

Saqib Rashid ◽

Tasleem Hosein ◽

...

Keyword(s):

Controlled Study ◽

Controlled Clinical Trial ◽

P Value ◽

Double Blind ◽

College Hospital ◽

Experienced Pain ◽

Significant Difference ◽

Quasi Experimental ◽

Post Hoc ◽

Irreversible Pulpitis

Objective: To compare the effect of single dose of three analgesics on postoperative endodontic pain following pulpectomy in teeth with irreversible pulpitis. Study Design: A quasi-experimental study. Place and Duration of Study: Endodontics Department, Fatima Jinnah Dental College Hospital Karachi, from Jan to Oct 2018. Methodology: In this Double Blind placebo controlled study, 120 subjects coming with the complaint of irreversible pulpitis in any one tooth were randomly allocated into 4 groups. Each group took either naproxen sodium (550mg), ibuprofen (400mg), tramadol (100mg) or placebo medication (multivitamin tablet) immediately after the pulpectomy appointment. A questionnaire was designed to assess the experienced pain based on VAS scale at 6, 12 and 24 hours postoperatively. KruskalWallis test was applied followed by post-hoc analysis to compare the VAS scores by taking p-value ≤0.05 as significant. Results: Pain levels were significantly lower in experimental groups as compared to placebo (p<0.001) but there was no statistically significant difference between the effectiveness of naproxen, ibuprofen and tramadol at 6, 12 and 24 hours postoperatively. Conclusion: Naproxen, Ibuprofen and Tramadol were found to beequally effective in reducing pain after instrumentation in teeth with irreversible pulpitis.

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Efficacy of Gemfibrozil as an Adjunct to Sertraline in Major Depressive Disorder, A Double-Blind, Randomized, and Placebo-Controlled Clinical Trial

Iranian Journal of Psychiatry ◽

10.18502/ijps.v16i1.5379 ◽

2021 ◽

Author(s):

Atefeh Zandifar ◽

Rahim Badrfam ◽

Ahmad Shamabadi ◽

Shakiba Jalilevand ◽

Shayan Pourmirbabaei ◽

...

Keyword(s):

Major Depressive Disorder ◽

Depressive Disorder ◽

Rating Scale ◽

Adjunctive Treatment ◽

Controlled Clinical Trial ◽

P Value ◽

Depression Symptoms ◽

Major Depressive ◽

Double Blind ◽

Significant Difference

Objective: Major depressive disorder (MDD) is predicted to be the first cause of burden of disease. The antidepressant activity of gemfibrozil has been recently considered. This study was designed to evaluate the effectiveness of gemfibrozil as a sertraline adjunct in treating patients with MDD. Method: A total of 46 patients with MDD based on the DSM-V criteria with a minimum score of 22 on the 17-item Hamilton Rating Scale for Depression (HAM-D) were randomized to receive either 300 mg daily gemfibrozil or placebo in addition to 100 mg sertraline for 8 weeks in a randomized, double-blind placebo-controlled trial. Patients were evaluated for response to treatment using the HAM-D score at baseline and weeks 2, 4, and 8. Results: Forty-five patients completed the study and took part in all follow-up visits. Repeated measure ANOVA with a Greenhouse-Geisser correction showed a significant difference for time×treatment interaction on within-subjects HAM-D scores [p–value= 0.026]. A significant difference was seen in time [p–value < 0.001]. The test of between-subject effects also showed a significant effect of treatment on HAM-D scores at weeks 2, 4, and 8 [p–value = 0.07]. Using KaplanMeier estimate curves, time to remission periods were significantly different between the 2 trial arms [Log-Rank p–value = 0.003]. Conclusion: Gemfibrozil is an effective adjunctive treatment in MDD and can be used to reduce depression symptoms.

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The effect of adding curcumin to sodium valproate in treatment of patients with bipolar disorder in the acute phase of mania: a clinical trial.

10.21203/rs.2.19925/v1 ◽

2020 ◽

Author(s):

Farzad Akbarzadeh ◽

Nabahat Niksun ◽

Fatemeh Behdani ◽

Amir Hoshang Mohammadpour ◽

Mahmoudreza Jaafari ◽

...

Keyword(s):

Sodium Valproate ◽

Control Group ◽

P Value ◽

Double Blind Study ◽

Young Mania ◽

Double Blind ◽

Diagnostic And Statistical Manual ◽

New Therapeutic Approaches ◽

Significant Difference ◽

Inflammatory Processes

Abstract Background: Inflammatory processes in the brain play an important role in etiopathogenesis of many psychiatric disorders including, bipolar mood disorder (BMD) as a life-long episodic disease. An inefficient therapeutic intervention especially for resistant cases makes the necessity of doing more precise investigation to find out new therapeutic approaches apparent. This double-blind study aims to investigate the effect of Crucumin as anti-inflammatory herbal based drug in the treatment of BMD. Results: 78 patients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for BMD screening to participate in the trial. The participants included 32 patients in the placebo group receiving sodium valproate and crucumin and 38 patients in the control group receiving placebo and sodium valproate. At the beginning of the study and weeks 1, 2, 4 the patients were assessed by a psychiatrist using Young mania score (YMRS). Fifty four patients completed the trial. Mean age in patients group was 36.28±10.73 and in control group was 32.42 ±9.60.Clinical characteristics of the patients, such as age, did not differ between groups P value ≥0.05. Results showed the process of changes were significant different in both group. The results showed that the changes in the resultss of YMRS, MMSE and CGI scores were significant in each group (P value≤0.001), but no significant difference has been detected between the two groups (p≥0.05).Conclusions: this study suggested that crucumin cannot be an effective adjuvant agent in management of patients with BMD under treatment with sodium valproate.

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Effects of Daily Consumption of an Aqueous Dispersion of Free-Phytosterols Nanoparticles on Individuals with Metabolic Syndrome: A Randomised, Double-Blind, Placebo-Controlled Clinical Trial

Nutrients ◽

10.3390/nu12082392 ◽

2020 ◽

Vol 12 (8) ◽

pp. 2392

Author(s):

Yasna K. Palmeiro-Silva ◽

Raúl I. Aravena ◽

Lisette Ossio ◽

Javiera Parro Fluxa

Keyword(s):

Metabolic Syndrome ◽

Placebo Group ◽

Daily Intake ◽

Aqueous Dispersion ◽

Blood Parameters ◽

Controlled Clinical Trial ◽

P Value ◽

Double Blind Study ◽

Daily Consumption ◽

Double Blind

Metabolic syndrome (MS) affects up to 40% of the population and is associated with heart failure, stroke and diabetes. Phytosterols (PS) could help to manage one or more MS criteria. The purpose of this study was to evaluate the therapeutic effect of daily supplementation of an aqueous dispersion of 2 g of free-phytosterols nanoparticles in individuals with MS over six months of intervention, compared with placebo. This double-blind study included 202 participants with MS randomly assigned into phytosterol (n = 102) and placebo (n = 100) groups. Participants were assessed at baseline, 4, 12 and 24 weeks. General health questions, anthropometric measurements and blood parameters were analysed. At week 24, the proportion of participants with high triglycerides (≥150 mg/dL) in the phytosterol group was 15.65% lower than in the placebo group (p-value = 0.023). Similarly, half of the participants in the phytosterol group decreased their waist circumference up to 4 cm compared with 0 cm in the placebo group (p-value = 0.0001). We reported no adverse effects (diarrhoea or vitamin D reduction); nonetheless, almost 70% of participants in the phytosterol group self-reported an improvement in bowel habits. Daily intake of free-PS nanoparticles improved some MS criteria; therefore, it might be a promising adjuvant therapy for individuals with MS (NCT02969720).

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A study of comparison between pre procedural ultrasound and real time ultrasound for spinal spaces

MedPulse International Journal of Anesthesology ◽

10.26611/10151921 ◽

2021 ◽

Vol 19 (2) ◽

pp. 27-30

Author(s):

Raghu K C ◽

Keyword(s):

Real Time ◽

Lumbar Puncture ◽

Research Centre ◽

P Value ◽

Double Blind Study ◽

Double Blind ◽

Significant Difference ◽

Group A ◽

Chest X Ray ◽

Midline Approach

Background: Use of thoracic epidurals for intra‑ and post‑operative analgesia for open abdominal surgeries has exponentially increased over the last decade. Spinal anaesthesia is used a landmark – guided midline approach, in these absent, indistinct or distorted in the presence of obesity, previous spinal surgeries, deformities, or degenerative changes associated with ageing. In the present study evaluates the efficacy of real‑time ultrasound (RUS)‑guided paramedian approach, and pre‑procedure ultrasound (PUS) landmark‑guided paramedian approach in obese persons. Methods: This is a Prospective Randomized Double-Blind Study conducted in Akash Institute of Medical Sciences and Research centre. Total 50 subjects (Group A – 25, Group A – 25). All the subjects included after informed consent, Along with Chest X- ray and ECG-for patients over 40 years of age. The primary end point was to attain a successful lumbar puncture. Variables like the number of attempts, the number of passes, the time taken for identifying landmark(s), and time for a successful lumbar puncture(s) were secondary end points and were recorded in both the groups. Results: This study was evaluated In real‑time ultrasound (RUS)‑guided paramedian approach, and pre‑procedure ultrasound (PUS) landmark‑guided paramedian approach in obese patients. There is a statistically high significant difference in PUS group than RUS Group. A P value < 0.002 is the statistically in between 2 groups. Conclusion: the space identification and number of attempts, passes and time consuming in pre procedure ultrasound when compared to real time ultrasound. This study suggest real time ultrasound is good for identification of space.

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