scholarly journals 73 The Use of Topical Anaesthetic in The Banding of Internal Haemorrhoids: A Feasibility Study for A Randomized Control Trial

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
V Sharma ◽  
D Sharma ◽  
A Stearns ◽  
J Hernon

Abstract Aim Rubber band ligation (RBL) is a procedure commonly performed in colorectal clinics for internal haemorrhoids. 90% of patients experience pain following RBL. We aimed to complete a feasibility randomized control trial assessing the role of topical anaesthetic before RBL of internal haemorrhoids. Method We performed a prospective, single-centre, single blinded, randomized(1:1) controlled feasibility trial. Patients presenting with symptomatic haemorrhoids suitable for banding were randomized to undergo the procedure with local anaesthetic or without(control). Pain scores and vasovagal symptoms were assessed at 0 minutes, 30minutes, 4 hours, and 72 hours after the procedure. Primary outcome measures were recruitment rate, participant retention rate, patient and surgeon acceptability. Secondary outcome measures were pain scores up to 72 hours, vasovagal episodes, new use of analgesia, and adverse outcomes. Results 35 patients (18 topical anaesthetic, group A; 17 no anaesthetic gel, group B) were recruited. Mean recruitment rate was 11.7 participants per month. 33(94%) participants remained in the study until completion, with 2 patients lost to telephone follow-up. The treatment was acceptable for 35(97%) eligible patients. 1 patient declined enrolment. The treatment was acceptable to all surgeons (100%). There was a significant difference in median pain scores of -2(95% CI -4.0 to -1.0, p = 0.0006) at the 30-minute time point only. There was no significant difference in vasovagal symptoms(p = 0.10) or new analgesia use(p = 0.85). Conclusions In conclusion, we have shown that a phase III clinical trial is feasible. We have demonstrated excellent patient recruitment and retention as well as patient and surgeon acceptability.

2019 ◽  
Vol 2 (11) ◽  
pp. 276-282
Author(s):  
Naiem Ahmed ◽  
Omprakash Yadav ◽  
Swati Joshi Asopa ◽  
Manju Panwar ◽  
Aarif Khan ◽  
...  

INTRODUCTION: Surgical extraction of third molar irrespective of any technique results in postoperative pain, swelling of face and limited mouth opening. The aim of the present study was to assess and compare the effects of Dexamethasone (4mg) administered prior to surgery.MATERIALS AND METHOD: A randomized control trial was conducted which included a total of fifty patients. All the patients were randomly put in two groups of twenty five each. Group I patients underwent transalveolar extraction of third molar under local anesthesia and standard oral drug regime. Group II patients received an additional submucosal injection of dexamethasone 4 mg, thirty minutes prior administration of local anaesthesia. Pain, swelling and mouth opening was recorded on second, seventh and tenth post-operative days after surgery.RESULTS: The difference in pain scores on second post-operative day between two groups were found statistically non-significant. However, there was significant reduction in pain scores on seventh and tenth day in both groups. Mouth opening showed statistically significant difference between the two groups.CONCLUSION: The observations of the present study provide a fundamental basis for the use of corticosteroids such as dexamethasone sodium phosphate in the form of submucosal administration in lower than usual doses to decrease postoperative inflammation when compare to other routes of drug administration.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Kyoungwon Baik ◽  
Seon Myeong Kim ◽  
Jin Ho Jung ◽  
Yang Hyun Lee ◽  
Seok Jong Chung ◽  
...  

AbstractWe investigated the efficacy of donepezil for mild cognitive impairment in Parkinson’s disease (PD-MCI). This was a prospective, non-randomized, open-label, two-arm study. Eighty PD-MCI patients were assigned to either a treatment or control group. The treatment group received donepezil for 48 weeks. The primary outcome measures were the Korean version of Mini-Mental State Exam and Montreal Cognitive Assessment scores. Secondary outcome measures were the Clinical Dementia Rating, Unified Parkinson’s Disease Rating Scale part III, Clinical Global Impression scores. Progression of dementia was assessed at 48-week. Comprehensive neuropsychological tests and electroencephalography (EEG) were performed at baseline and after 48 weeks. The spectral power ratio of the theta to beta2 band (TB2R) in the electroencephalogram was analyzed. There was no significant difference in the primary and secondary outcome measures between the two groups. However, the treatment group showed a significant decrease in TB2R at bilateral frontotemporoparietal channels compared to the control group. Although we could not demonstrate improvements in the cognitive functions, donepezil treatment had a modulatory effect on the EEG in PD-MCI patients. EEG might be a sensitive biomarker for detecting changes in PD-MCI after donepezil treatment.


BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e044168
Author(s):  
Prahlad Adhikari ◽  
Asish Subedi ◽  
Birendra Prasad Sah ◽  
Krishna Pokharel

ObjectivesThis study aimed to determine if low dose intravenous ketamine is effective in reducing opioid use and pain after non-elective caesarean delivery.DesignProspective, randomised, double-blind.SettingTertiary hospital, Bisheshwar Prasad Koirala Institute of Health Sciences, Dharan, NepalParticipants80 patients undergoing non-elective caesarean section with spinal anaesthesia.InterventionsPatients were allocated in 1:1 ratio to receive either intravenous ketamine 0.25 mg/kg or normal saline before the skin incision.Primary and secondary outcome measuresThe primary outcome was the total amount of morphine equivalents needed up to postoperative 24 hours. Secondary outcome measures were postoperative pain scores, time to the first perception of pain, maternal adverse effects (nausea, vomiting, hypotension, shivering, diplopia, nystagmus, hallucination) and neonatal Apgar score at 1 and 5 min, neonatal respiratory depression and neonatal intensive-care referral.ResultsThe median (range) cumulative morphine consumption during the first 24 hours of surgery was 0 (0–4.67) mg in ketamine group and 1 (0–6) mg in saline group (p=0.003). The median (range) time to the first perception of pain was 6 (1–12) hours and 2 (0.5–6) hours in ketamine and saline group, respectively (p<0.001). A significant reduction in postoperative pain scores was observed only at 2 hours and 6 hours in the ketamine group compared with placebo group (p<0.05). Maternal adverse effects and neonatal outcomes were comparable between the two groups.ConclusionsIntravenous administration of low dose ketamine before surgical incision significantly reduced the opioid requirement in the first 24 hours in patients undergoing non-elective caesarean delivery.Trial registration numberNCT03450499.


2021 ◽  
Vol 4 (1) ◽  
pp. 11-7
Author(s):  
Fritzky Indradata ◽  
Heri Dwi Purnomo ◽  
Muh. Husni Thamrin ◽  
Sugeng Budi Santoso ◽  
Ardana Tri Arianto ◽  
...  

Latar Belakang: Anestesi spinal mempunyai efek samping berupa hipotensi dan mual muntah. Tujuan: penelitian ini adalah membandingkan efek anestesi spinal bupivacain dosis normal 12,5 mg dan bupivacain dosis rendah 5 mg dengan fentanyl 50 mg pada seksio sesarea terhadap perubahan hemodinamik, ketinggian blok, onset, durasi dan efek samping. Subjek dan Metode: Penelitian double blind randomized control trial pada 36 pasien yang memenuhi kriteria. Pasien dibagi menjadi dua kelompok, yang masing-masing terdiri 18 pasien, kelompok 1 dilakukan anestesi spinal dengan bupivacain hiperbarik 5 mg ditambah adjuvan fentanyl 50 mcg, sedangkan kelompok 2 diberikan bupivacain hiperbarik 12,5 mg. Penilaian meliputi saat mula kerja blokade sensorik, mula kerja blokade motorik, durasi, tekanan darah, laju nadi, dan saturasi oksigen, lama kerja dan efek samping. Data hasil penelitian diuji secara statistik dengan uji chi-square. Hasil: Terdapat perbedaan signifikan pada onset dan durasi blokade sensorik dan motorik, bupivacain 12,5 mg lebih baik dibandingkan bupivacain 5 mg + fentanyl 50 mcg (p<0.05). Tidak ada perbedaan signifikan pada perubahan tanda vital dan efek samping (p>0.05). Simpulan: Bupivacain 12,5 mg menghasilkan onset lebih cepat dan durasi lebih lama dibandingkan bupivacain 5 mg + fentanil 50 mcg pada anestesi spinal untuk seksio sesarea   Comparison of The Effectiveness Spinal Anesthesia with Bupivacaine 12,5 Mg and Bupivacaine 5 Mg added Fentanyl 50 Mcg in Caesarean Section Abstract Background: Spinal anesthesia has side effects such as hypotension and nausea and vomiting. Objective: The aim of this study was to compare the effects of spinal anesthesia with normal doses of 12,5 mg of bupivacaine and 5 mg of low-dose bupivacaine with fentanyl 50 mg in the cesarean section on hemodynamic changes, block height, onset, duration, and side effects. Subjects and Methods: Double-blind randomized control trial in 36 patients who met the criteria. Patients were divided into two groups, each consisting of 18 patients, group 1 underwent spinal anesthesia with 5 mg of hyperbaric bupivacaine plus 50 mcg of fentanyl adjuvant, while group 2 was given 12,5 mg of hyperbaric bupivacaine. Assessments include the initiation of sensory block action, onset of motor block action, duration, blood pressure, pulse rate, and oxygen saturation, duration of action, and side effects. The research data were statistically tested with the chi-square test. Results: There were significant differences in the onset and duration of sensory and motor blockade, bupivacaine 12,5 mg was better than bupivacaine 5 mg + fentanyl 50 mcg (p <0.05). There was no significant difference in changes in vital signs and side effects (p> 0.05). Conclusion: Bupivacaine 12,5 mg resulted in a faster onset and longer duration than bupivacaine 5 mg + fentanyl 50 mcg in spinal anesthesia for cesarean section.


PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0258752
Author(s):  
Azza Alketbi ◽  
Salah Basit ◽  
Nouran Hamza ◽  
Lori M. Walton ◽  
Ibrahim M. Moustafa

Background Fatigue is considered one of the most common symptoms of multiple sclerosis (MS) and lacks a current standardized treatment. Therefore, the aim of this study was to examine the feasibility and effectiveness of a cognition-targeted exercise versus symptom-targeted exercise for MS fatigue. Methods In this Pilot, parallel-group, randomized controlled trial, sixty participants with multiple sclerosis, were randomly assigned to either a Cognition-Targeted Exercise (CTE) (N = 30, mean age 41) or a Symptom-Targeted Exercise (STE) (N = 30, mean age 42). The participants in the experimental group received eight, 50-minute sessions of weekly Cognitive Behavior Therapy (CBT) in addition to a CTE Program; whereas, participants in the control group received eight, 50-minute sessions of weekly CBT in addition to the standardized physiotherapy program (STE Program). Feasibility was assessed through recruitment rate, participant retention, adherence and safety, in addition to clinical outcome measures, including: (1) Modified Fatigue Impact Scale (MFIS), (2) Work and Social Adjustment Scale (WSAS), (3) Hospital Anxiety and Depression Scale (HADS), and Perceived Stress Scale (PSS). All outcome measures were assessed at baseline (pretreatment), following completion of the eight visit intervention protocol, and at 3-months follow-up. Results The recruitment rate was 60% and 93% of participants completed the entire study. The recruited participants complied with 98% of the required visits. No adverse events were recorded. A Generalized Estimation Equation Model revealed a significant difference over time as an interaction term during the post and follow up visit for all clinical outcome measures (p < .001). Conclusion The addition of CTE to CBT exhibited positive and more lasting influence on MS fatigue outcomes compared to Symptom-Targeted Exercise (STE). Feasibility and efficacy data from this pilot study provide support for a full-scale RCT of CTE as an integral component of Multiple Sclerosis fatigue management.


Author(s):  
Bibi Haleema ◽  
Huma Riaz

Abstract Objective: The objective of study was to determine the effects of thoracic spine manipulation on interscapular pain and pain pressure sensitivity, thoracic mobility and disability due to active myofascial trigger points in rhomboid muscle. Methods: A randomized control trial was conducted at Women Institute of Rehabilitation Sciences Abbottabad, from July to December 2019.Ethical permission was taken fromResearch ethical committee of Riphah international university Islamabad. Participants were selected through non-probability purposive sampling technique as per inclusion criteria. It consisted of 60 participants with forward head posture having active trigger points in rhomboid muscle, with age ranging from 18 to 30 years. The participants were randomly allocated through sealed envelope method into two groups that are experimental and control. Experimental group has received thoracic manipulation along with conventional physical therapy (CPT) whereas control group has only received CPT including manual pressure release and therapeutic exercise. Intervention was applied with 2 sessions / week with 3 weeks in total. Pre and Post assessment was done with outcome measurement tools comprised of Numeric pain rating scale (NPRS) for pain severity, Algometry for pain pressure threshold(PPT), Inclinometer for Range of movement(ROM) and Neck disability index (NDI) for associated disability. Data analysis was done using SPSS-20 version. Results: Between group analysis has shown significant improvement of pain & pain pressure sensitivity with p value <0.01 and <0.05 respectively. All outcome measures have shown significant difference in pre post treatment (p<.000) in both groups. Continuous...


2019 ◽  
Vol 5 (1) ◽  
pp. 64-68
Author(s):  
Ali Imam Ahsan ◽  
Nasimul Jamal ◽  
Ashfaq Ahmad ◽  
Syed Farhan Ali ◽  
Momenul Haque

Background: Treatment of granular myringitis (GM) is diverse with no definitive management. Objective: The aim of the present study was to see the effectiveness of different interventions for treating granular myringitis. Methodology: This was a single centred, parallel, randomized control trial. This study was done at the Specialized ENT Hospital of SAHIC, Dhaka from July 2010 to June 2012. Patients presenting with granular myringitis of 18 years of age or more with both sexes were included. All patients were divided into two groups by simple random sampling method of which patients of group A were treated by surgical treatment and that of group B were treated by medical treatment. Medical treatment was given in the form of topical ear drops and surgical treatment was performed by surgical debridement of granulation tissue followed by chemical cauterization. Repeated follow up was performed up to 6 months in both groups of treated patients. The primary outcome was the resolution of granulation tissue. During follow-up the secondary outcome variables were recurrence, perforation of the TM and any other complications or complain from the patients. Results: A total number of 60 patients were studied of which 30 patients were treated medically and 30 patients were treated surgically. The cure rate was higher in surgical treatment (80%) than conservative (16.7%) (p=0.011). The recurrence rate (17.24%) is also less in surgical group compared to medical treatment group (77.27%) (p=0.001). Conclusion: Surgical treatment is a more successful treatment modality for granular myringitis. Journal of National Institute of Neurosciences Bangladesh, 2019;5(1): 64-68


2010 ◽  
Vol 28 (23) ◽  
pp. 3673-3679 ◽  
Author(s):  
Amanda R. Moraska ◽  
Amit Sood ◽  
Shaker R. Dakhil ◽  
Jeff A. Sloan ◽  
Debra Barton ◽  
...  

Purpose Fatigue is one of the most common symptoms experienced by patients with cancer. This trial was developed to evaluate the efficacy of long-acting methylphenidate for improving cancer-related fatigue and to assess its toxicities. Patients and Methods Adults with cancer were randomly assigned in a double-blinded manner to receive methylphenidate (target dose, 54 mg/d) or placebo for 4 weeks. The Brief Fatigue Inventory was the primary outcome measure, while secondary outcome measures included a Symptom Experience Diary (SED), the Short Form-36 (SF-36) Vitality Subscale, a linear analog self-assessment, the Pittsburgh Sleep Quality Index, and the Subject Global Impression of Change. Results In total, 148 patients were enrolled. Using an area under the serum concentration-time curve analysis, there was no evidence that methylphenidate, as compared with placebo, improved the primary end point of cancer-related fatigue in this patient population (P = .35). Comparisons of secondary end points, including clinically significant changes in quality-of-life variables and cancer-related fatigue change from baseline, were similarly negative. However, a subset analysis suggested that patients with more severe fatigue and/or with more advanced disease did have some fatigue improvement with methylphenidate (eg, in patients with stage III or IV disease, the mean improvement in usual fatigue was 19.7 with methylphenidate v 2.1 with placebo; P = .02). There was a significant difference in self-reported toxicities (SED), with increased levels of nervousness and appetite loss in the methylphenidate arm. Conclusion This clinical trial was unable to support the primary prestudy hypothesis that the chosen long-acting methylphenidate product would decrease cancer-related fatigue.


Neurology ◽  
2017 ◽  
Vol 89 (24) ◽  
pp. 2413-2421 ◽  
Author(s):  
Iris Brunner ◽  
Jan Sture Skouen ◽  
Håkon Hofstad ◽  
Jörg Aßmus ◽  
Frank Becker ◽  
...  

Objective:To compare the effectiveness of upper extremity virtual reality rehabilitation training (VR) to time-matched conventional training (CT) in the subacute phase after stroke.Methods:In this randomized, controlled, single-blind phase III multicenter trial, 120 participants with upper extremity motor impairment within 12 weeks after stroke were consecutively included at 5 rehabilitation institutions. Participants were randomized to either VR or CT as an adjunct to standard rehabilitation and stratified according to mild to moderate or severe hand paresis, defined as ≥20 degrees wrist and 10 degrees finger extension or less, respectively. The training comprised a minimum of sixteen 60-minute sessions over 4 weeks. The primary outcome measure was the Action Research Arm Test (ARAT); secondary outcome measures were the Box and Blocks Test and Functional Independence Measure. Patients were assessed at baseline, after intervention, and at the 3-month follow-up.Results:Mean time from stroke onset for the VR group was 35 (SD 21) days and for the CT group was 34 (SD 19) days. There were no between-group differences for any of the outcome measures. Improvement of upper extremity motor function assessed with ARAT was similar at the postintervention (p = 0.714) and follow-up (p = 0.777) assessments. Patients in VR improved 12 (SD 11) points from baseline to the postintervention assessment and 17 (SD 13) points from baseline to follow-up, while patients in CT improved 13 (SD 10) and 17 (SD 13) points, respectively. Improvement was also similar for our subgroup analysis with mild to moderate and severe upper extremity paresis.Conclusions:Additional upper extremity VR training was not superior but equally as effective as additional CT in the subacute phase after stroke. VR may constitute a motivating training alternative as a supplement to standard rehabilitation.ClinicalTrials.gov identifier:NCT02079103.Classification of evidence:This study provides Class I evidence that for patients with upper extremity motor impairment after stroke, compared to conventional training, VR training did not lead to significant differences in upper extremity function improvement.


F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 876
Author(s):  
Hamed Esfandiari ◽  
Nils A. Loewen ◽  
Kiana Hassanpour ◽  
Ali Fatourechi ◽  
Shahin Yazdani ◽  
...  

Background: The aim of this study was to compare the safety and efficacy of primary trabeculectomy with mitomycin C and Ahmed glaucoma valve (AGV) implantation in patients with Fuchs heterochromic iridocyclitis (FHIC)-related glaucoma, a rare complication of an uncommon form of uveitis. Methods: In this retrospective comparative case series, 26 FHIC-associated glaucoma patients received trabeculectomy (n=12) or an AGV (n=14). Primary outcome measures were surgical success, defined as intraocular pressure (IOP) ≤21 mmHg, decreasing ≥20% from baseline, and no secondary glaucoma surgery. Secondary outcome measures were the number of glaucoma medications, complications, best corrected visual acuity (BCVA), and IOP. Results: The follow-up was 34.0±17.7 months in patients that received trabeculectomy and 33.4±18.6 months in AGV (P= 0.837). The cumulative probability of success rate was 41.7% for trabeculectomy and 85.7% for AGV, with no significant difference in complications (P>0.05). The IOP in patients that received trabeculectomy dropped from 23.4±3.3 mmHg to 21.6±5.2 mmHg at the final visit (P= 0.041). In patients that received AGV, the IOP decreased from 24±7.8 to 17.1±2.6 mmHg (P= 0.003). The number of glaucoma medications at baseline were 3.3±0.5 in those that received trabeculectomy and 3±0.6 in those that received AGV (P=0.233), and decreased to 2.4±1.0 (P=0.008) and 1.7±0.6 (P=0.002), respectively. BCVA was equal in both groups and did not change (P>0.05). Conclusion: Primary AGV had a higher success rate than trabeculectomy, with patients also needing fewer medications for the management of FHIC-associated glaucoma.


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