Spinal Anesthesia and Spinal Anesthesia with Subdiaphragmatic Lidocaine in Shoulder Pain Reduction for Gynecological Laparoscopic Surgery: A Randomized Clinical Trial

Objective. The aim of this study was to compare the effectiveness of spinal anesthesia with subdiaphragmatic lidocaine at the beginning of surgery versus spinal anesthesia in pain reduction for gynecological laparoscopic surgery. Methods. This was a clinical trial conducted in Arash Hospital, Tehran, Iran. Eighty-four patients were randomized to either spinal anesthesia with subdiaphragmatic lidocaine, spinal anesthesia, or general anesthesia (GA). The primary outcome was patients’ pain perception during surgery, 2, 4, 6, and 12 hours after surgery, and prior to discharge and was assessed by visual analogue scale (VAS). Results. The results showed that there are no significant changes in pain perception over time in none of the three groups (F(4,76) = 0.37, P=0.82). The severity of pain experienced by patients at all-time interval after surgery was similar between groups [F(2,79) = 0.54, P=0.58]. Conclusion. The use of subdiaphragmatic lidocaine at the beginning of surgery combined with spinal anesthesia was not associated with a statistically significant difference in patients’ postoperative VAS scores compared to spinal anesthesia and GA during and after gynecological surgical procedures. The study was registered in Iranian Registry of Clinical Trial by the number of IRCT2016022226698N1.

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Clinical Comparison: Fast-Acting and Traditional Topical Dental Anesthetic

Anesthesia Progress ◽

10.2344/0003-3006-63.2.55 ◽

2016 ◽

Vol 63 (2) ◽

pp. 55-61 ◽

Cited By ~ 1

Author(s):

Arthur C. DiMarco ◽

Ann O'Kelley Wetmore

Keyword(s):

Clinical Trial ◽

Pain Perception ◽

Pain Reduction ◽

Topical Agent ◽

Analog Scale ◽

Topical Anesthetic ◽

Topical Gel ◽

Significant Difference ◽

The Mean ◽

Fast Acting

A randomized, nonblinded clinical trial compared the effectiveness of an application method of a fast-acting refrigerant topical agent to a 20% benzocaine gel topical. In a split-mouth design, right and left anterior middle superior alveolar injections (N = 30) were administered with a 27-gauge needle at least 24 hours apart with preinjection topicals. Using a cotton-tipped applicator, a refrigerant topical was applied for 5 seconds and 20% benzocaine gel for 2 minutes on opposite sides at 2 separate appointments. Subjects self-reported pain perception after each injection using a visual analog scale (VAS). The mean VAS ratings demonstrated no significant difference between the 5-second application of the refrigerant (M = 16.2, SD = 17.7) and the 2-minute application of 20% benzocaine topical gel anesthetic (M = 17.9, SD = 18.2). Fifty-seven percent of the subjects reported greater pain reduction with the refrigerant, 33% reported greater pain reduction with 20% benzocaine, and 10% reported no difference. Results suggest the described method of application of a refrigerant as an oral topical anesthetic has a faster onset and provides similar benefit in pain reduction compared with 20% benzocaine gel. The refrigerant was easy to accomplish and well received by subjects, indicating potential for routine use in dentistry.

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The Effect of Local Injections of Bupivacaine Plus Ketamine, Bupivacaine Alone, and Placebo on Reducing Postoperative Anal Fistula Pain: A Randomized Clinical Trial

The Scientific World JOURNAL ◽

10.1155/2014/424152 ◽

2014 ◽

Vol 2014 ◽

pp. 1-6 ◽

Cited By ~ 4

Author(s):

Alireza Kazemeini ◽

Mojgan Rahimi ◽

Mohammad Sadegh Fazeli ◽

Seyedeh Adeleh Mirjafari ◽

Hamid Ghaderi ◽

...

Keyword(s):

Clinical Trial ◽

Postoperative Pain ◽

Spinal Anesthesia ◽

Normal Saline ◽

Adult Patients ◽

Time Interval ◽

Random Allocation ◽

Anal Surgery ◽

Significant Difference ◽

Group 3

Background and Objective. This study aimed to compare the effects of different local anesthetic solutions on postoperative pain of anal surgery in adult patients.Method. In this randomized double-blind prospective clinical trial, 60 adult patients (18 to 60 years old) with physical status class I and class II that had been brought to a university hospital operating room for fistula anal surgery with spinal anesthesia were selected. Patients were randomly divided into 4 equal groups according to table of random numbers (created by Random Allocation Software 1). Group 1 received 3 mL of normal saline, group 2, 1 mL of normal saline plus 2 mL of bupivacaine 0.5%, group 3, 1 mL of ketamine plus 2 mL of bupivacaine 0.5%, and group 4, no infiltration. Intensity of pain in patients was measured using visual analogue scale (VAS) at 0 (transfer to ward), 2, 6, 12, and 24 hours after surgery. Time interval to administration of drugs and overall dose of drugs were measured in 4 groups.Results. Mean level of pain was the lowest in group 3 at all occasions with a significant difference, followed by groups 2, 4, and lastly 1 (P<0.001). Furthermore, groups 2 and 3 compared to groups 1 and 4 had the least overall dose of analgesics and requested them the latest, with a significant difference (P<0.05).Conclusion. Local anesthesia (1 mL of ketamine plus 2 mL of bupivacaine 0.5% or 1 mL of normal saline plus 2 mL of bupivacaine 0.5%) combined with spinal anesthesia reduces postoperative pain and leads to greater comfort in recovering patients.

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A comparison of the effect of dexamethasone and pethidine for prevention of shivering after spinal anesthesia in caesarean section: randomization clinical trial

Biomedical Research and Therapy ◽

10.15419/bmrat.v5i9.473 ◽

2018 ◽

Vol 5 (9) ◽

pp. 2646-2650 ◽

Cited By ~ 2

Author(s):

Hamideh Gholami ◽

Yousef Moradi ◽

Zaher Khazaei ◽

Shahrzad Tehrani

Keyword(s):

Clinical Trial ◽

Caesarean Section ◽

Spinal Anesthesia ◽

Normal Saline ◽

Saline Group ◽

Elective Cesarean Section ◽

Double Blind ◽

Dexamethasone Group ◽

Postanesthetic Shivering ◽

Significant Difference

Background: Postanesthetic shivering is one of the most common complications and problems after operations. Medications and drugs can be used to prevent postanesthetic shivering. The aim of this study is to compare the effects of Dexamethasone and Pethidine in preventing postanesthetic shivering after spinal anesthesia in Iranian women undergoing caesarean section. Method: This double-blind randomized clinical trial was performed in 66 pregnant women who were referred to Ayatollah Moosavi Hospital in Zanjan, Iran for elective cesarean section, from December 2011 to November 2012. All participants who have ASA I-II were randomly classified into three groups: Dexamethasone receivers (Group A), Pethidine receivers (Group B), and Normal Saline receivers (Group C). Data were collected and analyzed using SPSS16 software. IRCT registration number of this study is IRCT201112198469N1. Conclusion: Although statistically there was no significant difference between the three groups of Dexamethasone, Pethidine and Normal Saline receivers regarding shivering reduction; clinical complication rate in Dexamethasone group was lower comparedto Pethidine and Normal Saline groups. Results: There was no significant difference between three groups regarding shivering reduction. There were 11 (72.5%) trembling cases in Normal Saline group, 6 cases (27.3%) in Dexamethasone group, and 12 cases (54.5%) in Pethidine group.

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A comparative study on treatment outcomes of bandage and casting in non-displaced extra-articular fracture of distal radius: A clinical trial study

Polish Journal of Surgery ◽

10.5604/01.3001.0014.3760 ◽

2020 ◽

Vol 92 (5) ◽

pp. 1-5

Author(s):

Hamid Reza Arti ◽

Reza farahnak

Keyword(s):

Clinical Trial ◽

Distal Radius ◽

Dash Score ◽

Articular Fracture ◽

Appropriate Treatment ◽

Significant Difference ◽

Vas Scores ◽

The Difference ◽

Fracture Of Distal Radius

Background: There are some therapeutic choices in non-displaced extra-articular fracture of distal radius that confront with some controversy in their selection. We tried to study these two methods in this article. Methods: This was a prospective randomized clinical trial conducted on the patients (n=62) with NDEA fracture of distal radius, during 2015. The patients were randomly assigned to casting (n-32) or bandage (n=30) group to receive the respective fracture healing procedure. The patients were followed-up at the first, second, third, and sixth weeks after the treatment. The Disabilities of the DASH and the VAS questionnaire were completed. All patients underwent an X-ray radiographic assessment to evaluate any potential complication. Results: At the end of the study, in the bandage and casting group 30 and 32 patients finished the study. The statistical analyses showed that the bandage group showed significantly higher mean DASH score than the casting group at the first week, but for the second week the difference decreased so that for the third week, the casting group showed significantly higher value than the bandage group. Finally, at the sixth week the two groups showed no significant difference in the DASH value. The two groups showed no significant differences in the VAS scores for all follow up assessments. The returning time to work was shorter in the bandage group and the treatment cost was also lower in this group. Conclusion: Bandage is more appropriate treatment option for the NDEA fractures of distal radius.

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Pain Experience with Micro-osteoperforations during Initial Orthodontic Alignment: A Randomized Clinical Trial.

Journal Of Oral Research ◽

10.17126/joralres.2020.072 ◽

2020 ◽

Vol 9 (4) ◽

pp. 309-318

Author(s):

Azaitun Akma Shahrin ◽

◽

Sarah Haniza Abdul Ghani ◽

Noraina Hafizan Norman ◽

◽

...

Keyword(s):

Clinical Trial ◽

Repeated Measures ◽

Pain Perception ◽

Tooth Movement ◽

Intervention Group ◽

Orthodontic Tooth Movement ◽

Control Group ◽

Initial Alignment ◽

Significant Difference ◽

Fixed Appliances

Objetive: The objective of this clinical trial was to investigate the perception of pain during initial maxillary alignment with an adjunctive procedure of micro-osteoperforations (MOPs) compared to conventional orthodontics. Material and methods: This study design was a single-centre, two-arm parallel prospective randomised clinical trial. Thirty consecutive adult subjects (25 females and 5 males; mean age ± SD, 22.66 ± 3.27 years) with 5-8mm moderate upper labial segment crowding were randomly allocated using block randomisation into intervention and control group. All subjects had first premolar extractions, bonded conventional fixed appliances and 0.014-inch nickel-titanium archwire was placed for initial alignment. The intervention group received a 3-mm deep MOPs procedure under local anaesthesia using a Propel device (PROPEL Ortho Singapore) on the labiogingival aspect between the maxillary incisors. Both groups received a set of 100 mm visual analogue scale to complete over the first week, recording pain at 24 hours, 3 days and 1 week. Data were analysed using repeated-measures analysis of variance (ANOVA). Results: There was a statistically significant difference observed in perceived pain levels between MOPs and the control group on day 1, day 3 and day 7 postoperatively. Pain perception was significantly lower in the intervention group at all time points. Conclusion: Accelerating orthodontic tooth movement with MOPs did not accentuate pain perceived during initial maxillary alignment with fixed appliances.

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Comparison of Hemodynamic Response following Spinal Anesthesia between Controlled Hypertensive and Normotensive Patients Undergoing Surgery below the Umbilicus: An Observational Prospective Cohort Study

Anesthesiology Research and Practice ◽

10.1155/2021/8891252 ◽

2021 ◽

Vol 2021 ◽

pp. 1-9

Author(s):

Leake Gebrargs ◽

Bereket Gebremeskel ◽

Bacha Aberra ◽

Assefa Hika ◽

Yusuf Yimer ◽

...

Keyword(s):

Blood Pressure ◽

Heart Rate ◽

Cohort Study ◽

Spinal Anesthesia ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Study Groups ◽

Categorical Variables ◽

Time Interval ◽

Significant Difference

Background. Hypotension and bradycardia are the most common complications associated with spinal anesthesia and more common in patients with a history of hypertension. Regular use of antihypertensive medications can prevent these complications. The occurrence of hypotension under spinal anesthesia among controlled hypertensive and normotensive patients with age 40 years and above is still debated. The objective of the study was to compare blood pressure and heart rate changes following spinal anesthesia between controlled hypertensive and normotensive patients undergoing surgery below the umbilicus at Black lion hospital, Addis Ababa, Ethiopia, 2020. Method. A hospital-based prospective cohort study was conducted. A total of 110 elective patients with controlled hypertension (55) and normotensive (55) patients who underwent surgery with spinal anesthesia at black lion hospital during the study period were included. The sample was selected using a systematic random sampling technique. Continuous data of independent and dependent variables were analyzed using an independent sample t-test for normally distributed and Mann–Whitney U-test for nonnormally distributed between the study groups. Categorical variables between the study groups were analyzed using the chi-square test. Descriptive data were displayed using tables and figures. For continuous and categorical variables, a p value <0.05 was considered statistically significant. Results. The incidence of hypotension in the controlled hypertension group (23.6%) was higher than the normotensive group (7.3%) with p value of 0.018. The occurrence of bradycardia was seen to be 12.7% in each group with a p value >0.05. There was a statistically significant difference in the mean systolic blood pressure, mean arterial pressure, mean heart rate, and vasopressor consumption at the measurement time interval between controlled hypertension and normotensive groups. Conclusion. Under spinal anesthesia, patients with controlled hypertension are more likely to develop hypotension than normotensive patients, but on the occurrence of bradycardia, there was no statistically significant difference between the two groups.

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Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial

European Respiratory Journal ◽

10.1183/13993003.01471-2021 ◽

2021 ◽

pp. 2101471

Author(s):

Leo Sekine ◽

Beatriz Arns ◽

Bruna R. Fabro ◽

Murillo M. Cipolatt ◽

Rafael R. G. Machado ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Improvement ◽

Critically Ill ◽

Primary Outcome ◽

Ventilatory Support ◽

Standard Of Care ◽

Randomised Clinical Trial ◽

Open Label ◽

Hospitalised Patients ◽

Significant Difference

BackgroundThe effects of convalescent plasma (CP) therapy hospitalised patients with coronavirus disease 2019 (COVID-19) remain uncertain. This study investigates the effect CP on clinical improvement in these patients.MethodsThis is an investigator-initiated, randomised, parallel arm, open-label, superiority clinical trial. Patients were randomly (1:1) assigned to two infusions of CP plus standard of care (SOC) or SOC alone. The primary outcome was the proportion of patients with clinical improvement 28 days after enrolment.ResultsA total of 160 (80 in each arm) patients (66.3% were critically ill and 33.7%, severe) completed the trial. The median age was 60.5 years (interquartile range [IQR], 48–68), 58.1% were men and the median time from symptom onset to randomisation was 10 days (IQR, 8–12). Neutralising antibodies titres >1:80 were present in 133 (83.1%) patients at baseline. The proportion of patients with clinical improvement on day 28 was 61.3% in the CP+SOC and 65.0% in the SOC group (difference, −3.7%; 95% Confidence Interval [CI], −18.8%-11.3%). The results were similar in the subgroups of severe and critically ill. There was no significant difference between CP+SOC and SOC groups in prespecified secondary outcomes, including 28-day mortality, days alive and free of respiratory support and duration of invasive ventilatory support. Inflammatory and other laboratorial markers values on days 3, 7 and 14 were similar between groups.ConclusionsCP+SOC did not result in a higher proportion of clinical improvement on at day 28 in hospitalised patients with COVID-19 compared to SOC alone.

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Single-Needle Arthrocentesis with Upper Compartment Distension versus Conventional Two-Needle Arthrocentesis: Randomized Clinical Trial

Pain Research and Management ◽

10.1155/2017/2435263 ◽

2017 ◽

Vol 2017 ◽

pp. 1-5 ◽

Cited By ~ 8

Author(s):

Eduardo Grossmann ◽

Primo Guilherme Vargas Pasqual ◽

Rodrigo Lorenzi Poluha ◽

Lilian Cristina Vessoni Iwaki ◽

Liogi Iwaki Filho ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Disc Displacement ◽

Articular Disc ◽

Analog Scale ◽

Significant Difference ◽

Interincisal Distance ◽

Vas Scores ◽

Tmj Pain ◽

One Year

The objective of this study was to compare single-needle arthrocentesis with distension of the upper compartment of the temporomandibular joint (TMJ) with the conventional two-needle arthrocentesis. Twenty-six patients with articular disc displacement without reduction (DDWOR) were included in the study and assigned to two groups (n=13): single-needle arthrocentesis with distension of the upper compartment of the TMJ (1N) and conventional two-needle arthrocentesis (2N). The maximum interincisal distance (MID) and TMJ pain as measured by the visual analog scale (VAS) were compared. MID and VAS data were obtained: before (T1), seven days after (T2), fifteen days after (T3), one month after (T4), three months after (T5), six months after (T6), nine months after (T7), and one year after the arthrocentesis procedures (T8). Considering each group individually, results of the VAS scores and MID measurements showed a significant difference between T1 and T2–T8 (p<0.001) in both groups. Between two groups, results show no significant differences (p>0.05). Both techniques tested were effective in reducing pain and increasing MID. Due to the advantages over the conventional two-needle arthrocentesis, single-needle arthrocentesis with distension of the upper compartment should be considered as the first treatment option for patients with painful hypomobilized TMJ of DDWOR.

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Bleeding complications of thromboprophylaxis with dabigatran, nadroparin or rivaroxaban for 6 weeks after total knee arthroplasty surgery: a randomised pilot study

BMJ Open ◽

10.1136/bmjopen-2020-040336 ◽

2021 ◽

Vol 11 (1) ◽

pp. e040336

Author(s):

Lucia van der Veen ◽

Marijn Segers ◽

Jos JAM van Raay ◽

Carina LE Gerritsma-Bleeker ◽

Reinoud W Brouwer ◽

...

Keyword(s):

Clinical Trial ◽

Total Knee Arthroplasty ◽

Pilot Study ◽

Knee Arthroplasty ◽

Major Bleeding ◽

Primary Outcome ◽

Bleeding Event ◽

Bleeding Complications ◽

Significant Difference ◽

Total Knee

ObjectivesFor the non-vitamin-K oral anticoagulants, data on bleeding when used for 42 days as thromboprophylaxis after total knee arthroplasty (TKA) are scarce. This pilot study assessed feasibility of a multicentre randomised clinical trial to evaluate major and clinically relevant non-major bleeding during 42-day use of dabigatran, nadroparin and rivaroxaban after TKA.Patients and methodsIn 70 weeks, between July 2012 and November 2013, 198 TKA patients were screened for eligibility in the Martini Hospital (Groningen, the Netherlands). Patients were randomly assigned to dabigatran (n=45), nadroparin (n=45) or rivaroxaban (n=48). The primary outcome was the combined endpoint of major bleeding and clinically relevant non-major bleeding. Secondary endpoints of this study were the occurrence of clinical venous thromboembolism (VTE) (pulmonary embolism or deep venous thrombosis), compliance, duration of hospital stay, rehospitalisation, adverse events and Knee Injury and Osteoarthritis Outcome Score (KOOS).ResultsThe primary outcome was observed in 33.3% (95% CI 20.0% to 49.0%), 24.4% (95% CI 12.9% to 39.5%) and 27.1% (95% CI 15.3% to 41.8%) of patients who received dabigatran, nadroparin or rivaroxaban, respectively (p=0.67). Major bleeding was found in two patients who received nadroparin (p=0.21). Clinically relevant non-major bleeding was observed in 33.3% (95% CI 20.0% to 49.0%), 22.2% (95% CI 11.2% to 37.1%) and 27.1% (95% CI 15.3% to 41.8%) for dabigatran, nadroparin and rivaroxaban, respectively (p=0.51). Wound haematoma was the most observed bleeding event. VTE was found in one patient who received dabigatran (p=0.65). The presurgery and postsurgery KOOS qQuestionnaires were available for 32 (71%), 35 (77%) and 35 (73%) patients for dabigatran, nadroparin and rivaroxaban, respectively. KOOS was highly variable, and no significant difference between treatment groups in mean improvement was observed.ConclusionsA multicentre clinical trial may be feasible. However, investments will be substantial. No differences in major and clinically relevant non-major bleeding events were found between dabigatran, nadroparin and rivaroxaban during 42 days after TKA. KOOS may not be suitable to detect functional loss due to bleeding.Trial registration numberNCT01431456.

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