scholarly journals Preemptive analgesia for postoperative pain relief in thoracolumbosacral spine operations: a double-blind, placebo-controlled randomized trial

2018 ◽  
Vol 29 (6) ◽  
pp. 647-653 ◽  
Author(s):  
Linda S. Aglio ◽  
Muhammad M. Abd-El-Barr ◽  
Vwaire Orhurhu ◽  
Grace Y. Kim ◽  
Jie Zhou ◽  
...  

OBJECTIVEPreemptive administration of analgesic medication is more effective than medication given after the onset of the painful stimulus. The efficacy of preoperative or preemptive pain relief after thoracolumbosacral spine surgery has not been well studied. The present study was a double-blind, placebo-controlled randomized trial of preemptive analgesia with a single-shot epidural injection in adult patients undergoing spine surgery.METHODSNinety-nine adult patients undergoing thoracolumbosacral operations via a posterior approach were randomized to receive a single shot of either epidural placebo (group 1), hydromorphone alone (group 2), or bupivacaine with hydromorphone (group 3) before surgery at the preoperative holding area. The primary outcome was the presence of opioid sparing and rescue time—defined as the time interval from when a patient was extubated to the time pain medication was first demanded during the postoperative period. Secondary outcomes include length of stay at the postanesthesia care unit (PACU), pain score at the PACU, opioid dose, and hospital length of stay.RESULTSOf the 99 patients, 32 were randomized to the epidural placebo group, 33 to the hydromorphone-alone group, and 34 to the bupivacaine with hydromorphone group. No significant difference was seen across the demographics and surgical complexities for all 3 groups. Compared to the control group, opioid sparing was significantly higher in group 2 (57.6% vs 15.6%, p = 0.0007) and group 3 (52.9% vs 15.6%, p = 0.0045) in the first demand of intravenous hydromorphone as a supplemental analgesic medication. Compared to placebo, the rescue time was significantly higher in group 2 (187 minutes vs 51.5 minutes, p = 0.0014) and group 3 (204.5 minutes vs 51. minutes, p = 0.0045). There were no significant differences in secondary outcomes.CONCLUSIONSThe authors’ study demonstrated that preemptive analgesia in thoracolumbosacral surgeries can significantly reduce analgesia requirements in the immediate postoperative period as evidenced by reduced request for opioid medication in both analgesia study groups who received a preoperative analgesic epidural. Nonetheless, the lack of differences in pain score and opioid dose at the PACU brings into question the role of preemptive epidural opioids in spine surgery patients. Further work is necessary to investigate the long-term effectiveness of preemptive epidural opioids and their role in pain reduction and patient satisfaction.Clinical trial registration no.: NCT02968862 (clinicaltrials.gov)

Author(s):  
Jose Lenin Beltran Gonzalez ◽  
Mario González Gámez ◽  
Emanuel Antonio Mendoza Enciso ◽  
Ramiro Josue Esparza Maldonado ◽  
Daniel Hernández Palacios ◽  
...  

AbstractBackgroundIn the search for active drugs against COVID-19, the indications of many have been redirected. Ivermectin and Hydroxychloroquine are drugs that inhibit viral replication in vitro and that have been used in several medical centers.ObjectivesThis clinical trial analyzes the efficacy of Ivermectin and Hydroxychloroquine in patients with moderate COVID-19 and in need of hospitalization.MethodsThis a controlled, clinical, randomized, double-blind trial that included patients with COVID-19-induced pneumonia and hospitalization criteria, but no severe respiratory failure. Patients were randomized to one of three groups: Group1-hydroxychloroquine, 400 mg every 12 hours on the first day and subsequently, 200 mg every 12 hours for 4 days, Group 2-ivermectin, 12 mg or 18 mg, according to patient weight and, Group 3-placebo. At inclusion, blood samples for arterial blood gases and biochemical markers associated with a poor prognosis were obtained. The primary outcome was established as the duration of hospitalization until discharge due to patient improvement, the total duration of hospitalization, and the safety outcomes were either respiratory deterioration or death.ResultsDuring the month of August, the admission of patients requiring hospitalization mostly encompassed cases with severe respiratory failure, so we ended the recruitment process and analyzed the data that was available at the time. One hundred and six (106) patients with an average age of 53 yrs. (±16.9) were included, with a greater proportion of males (n=66, 62.2 %). Seventy-two percent (72%) (n= 76) had an associated comorbidity. Ninety percent (90 %) of patients were discharged due to improvement (n=96). The average duration of hospitalization was 6 days (IQR, 3 – 10). No difference in hospitalization duration was found between the treatment groups (Group1: 7 vs Group 2: 6 vs Group 3: 5, p=0.43) nor in respiratory deterioration or death (Group 1: 18 % vs Group 2: 22.2 % vs Group 3: 24.3 %, p =0.83).ConclusionsIn non-critical hospitalized patients with COVID-19 pneumonia, neither ivermectin nor hydroxychloroquine decreases the number of in-hospital days, respiratory deterioration, or deaths.ClinicalTrials identifier NCT04391127


Author(s):  
Benjamin Gaborit ◽  
Eric Dailly ◽  
Bernard Vanhove ◽  
Régis Josien ◽  
Karine Lacombe ◽  
...  

Objective: We assessed the pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal antibody against SARS-CoV-2, in COVID-19-related moderate pneumonia. To evaluate the optimal dose and safety of XAV-19 during this first administration to patients with COVID-19-related moderate pneumonia. Methods : In this phase 2a trial, adults with COVID-19-related moderate pneumonia of ≤10 days duration were randomized to infusion of XAV-19 0.5mg/kg at day 1 and day 5 (group 1), 2mg/kg at day 1 and day 5 (group 2), 2mg/kg at day 1 (group 3) or placebo. Results : Eighteen patients (n=7 for group 1, n=1 for group 2, n=5 for group 3, and n=5 for placebo) were enrolled. Baseline characteristics were similar across groups, XAV-19 serum concentrations (μg/mL, median, range) at C max and at day 8 were 9.1 (5.2-18.1) and 6.4 (2.8-11.9), 71.5 and 47.2, and 50.4 (29.1-55.0) and 20.3 (12.0-22.7) for groups 1, 2 and 3, respectively (p=0.012). Terminal half-life (median, range) was estimated at 11.4 (5.5-13.9) days for 2 mg/kg of XAV-19 at day 1. Serum XAV-19 concentrations were above the target concentration of 10 μg/mL (tow fold the in vitro 100% inhibitory concentration [IC 100 ]) from the end of perfusion to more than 8 days for XAV-19 2 mg/kg at day 1. No hypersensitivity or infusion-related reactions were reported during treatment, there was no discontinuation for adverse events and no serious adverse events related to study drug. Conclusions : Single intravenous dose of 2mg/kg of XAV-19 demonstrated high serum concentrations, predictive of potent durable neutralizing activity with good tolerability. Trial registration: ClinicalTrials.gov Identifier: NCT04453384


2015 ◽  
Vol 2 (2) ◽  
pp. 46-51
Author(s):  
Anuj Jung Rayamajhi ◽  
Balbrishna Bhattarai ◽  
Birendra Prasad Shah

Background: Epidural block with local anaesthetic with or without additives is being used for perioperative analgesia. Various additives have been used to enhance the effect of regional blocks including epidural blocks. This study aimed to investigate the effect of adding a single shot epidural dexamethasone to bupivacaine on postoperative analgesia and dose of rescue analgesics used.Methods: A prospective, randomized, double blinded study was conducted in 90 adult patients undergoing lower abdominal surgery. The patients were randomized into two groups. Group 1 received 9ml of 0.5% bupivacaine plain with 1 ml of normal saline. Group 2 received 9ml of 0.5% bupivacaine plain 9 ml with 1 ml of dexamethasone (4mg). After standard balanced anesthesia technique, patients were observed in postoperative period for pain and hemodynamic variables accordingly.Results: Our study showed significantly longer duration of analgesia of 468 minutes (almost 8 hours) when dexamethasone was added to bupivacaine for single shot epidural injection compared to 271 minutes (approximately 4 and half hours) when bupivacaine alone was used (p<0.001). Consumption of rescue analgesic, Tramadol, was significantly lower in dexamethasone group in 24 hours (169.31±50.82 mg in Group 1 and 114.77±60.59mg in Group 2, p<0.001). No adverse events were noted.Conclusion: Addition of dexamethasone to bupivacaine for single shot epidural block almost doubled the duration of analgesia. Single shot epidural block using bupivacaine with addition of dexamethasone provides effective post operative analgesia and significantly reduced the postoperative rescue analgesic requirement.Journal of Society of Anesthesiologists of Nepal 2015; 2(2): 46-51


2017 ◽  
Vol 9 ◽  
pp. 176 ◽  
Author(s):  
Diah Ayu Maharani ◽  
Alia Ramadhani ◽  
Melissa Adiatman ◽  
Yuniardini Septorini Wimardhani ◽  
Linda Kusdhany ◽  
...  

Objective: This study aimed at comparing the antiplaque, anticalculus, and antigingivitis potentials of a mouth rinse containing essential oil, alcohol,zinc, and fluoride with a mouth rinse containing cetylpyridinium chloride (CPC) 0.1% over 1-, 2-, and 3-month periods.Methods: This study was a double-blind, parallel randomized clinical trial with a 3-day run-in phase. Respondents were asked to gargle twice dailywith 15 ml of mouth rinse for 30 seconds after brushing teeth. Respondents were 80 females with a mean age of 21 years, and a single dental examinerwas employed throughout the study to decrease the variance. Prophylaxis was performed for all respondents before the intervention. Three mouthrinses were tested: Group 1 with the mouth rinse containing CPC 0.1%, Group 2 as the negative control, and Group 3 as the positive control with amouth rinse containing alcohol. Evaluations were conducted by plaque index, gingival index, calculus index, and CariScreen examinations.Results: The clinical trial showed that the mouth rinse with alcohol and the mouth rinse containing CPC 0.1% were effective in inhibiting bacterialbuildup (antiplaque) and have anticalculus properties, but with no statistically significant antigingivitis effect.Conclusion: It was found that the mouth rinse containing alcohol has similar effectiveness with CPC 0.1% mouth rinse, but side effects, such as aburning sensation, were reported in the alcohol-containing mouth rinse.


2012 ◽  
Vol 30 (27) ◽  
pp. 3389-3395 ◽  
Author(s):  
Joseph A. Roscoe ◽  
Charles E. Heckler ◽  
Gary R. Morrow ◽  
Supriya G. Mohile ◽  
Shaker R. Dakhil ◽  
...  

Purpose We conducted a double-blind randomized clinical trial of the following four regimens for controlling delayed nausea (DN): group 1: palonosetron + dexamethasone on day 1 with prochlorperazine on days 2 and 3; group 2: granisetron + dexamethasone on day 1 with prochlorperazine on days 2 and 3; group 3: aprepitant + palonosetron + dexamethasone on day 1 with aprepitant + dexamethasone on days 2 and 3; and group 4: palonosetron + dexamethasone on day 1 with prochlorperazine + dexamethasone on days 2 and 3. Patients and Methods Chemotherapy-naive patients received doxorubicin, epirubicin, cisplatin, carboplatin, or oxaliplatin. The primary end point was average nausea assessed four times daily on days 2 and 3. Primary analyses were whether nausea control would be improved by using palonosetron versus granisetron on day 1 (group 1 v group 2); by adding dexamethasone on days 2 and 3 (group 1 v group 4); and by using aprepitant versus prochlorperazine (group 3 v group 4). Statistical significance was set at P = .017. Results Two hundred thirty-four, 234, 241, and 235 evaluable patients were accrued to groups 1, 2, 3, and 4, respectively. Adjusted mean differences for the three planned analyses were as follows: palonosetron versus granisetron: −0.01 (95% CI, −0.23 to 0.20; P = .72); adding dexamethasone on days 2 and 3: 0.20 (95% CI, −0.02 to 0.41; P = .01); and using aprepitant versus prochlorperazine: −0.03 (95% CI, −0.24 to 0.19; P = .56). Conclusion The addition of dexamethasone on days 2 and 3 reduced DN. Palonosetron and granisetron have similar effects on DN. The beneficial effect of adding aprepitant for control of DN was the same as adding prochlorperazine.


2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Andri M. T. Lubis ◽  
Rangga B. V. Rawung ◽  
Aida R. Tantri

Acute pain is the most common early complication after total knee arthroplasty causing delayed mobilization and increased demands of morphine, leading to higher operative cost. Several studies have assessed the effectiveness, side-effects, and ease of use of various analgesics. Preemptive analgesia with combined celecoxib and pregabalin has been reported to yield positive outcomes. In this randomized, double-blind controlled clinical trial, 30 subjects underwent surgery for total knee arthroplasty using 15-20mg bupivacaine 5% epidural anesthesia. All subjects were divided into three groups. Group 1 was given celecoxib 400mg and pregabalin 150mg 1 hour before the operation, Group 2 was given celecoxib 200mg and pregabalin 75mg twice daily starting from 3 days before the operation, and Group 3 was given a placebo. The outcome was measured with Visual Analog Scale, knee range of motion, and postoperative mobilization. There was a significant difference in postoperative morphine usage between the groups that were administered with preemptive analgesia and the placebo group, but no significant difference was found between Group 1 and Group 2 that were given preemptive analgesia at different doses. ROM and postoperative mobilization were not significantly different among the three groups. Two patients in the first group, one patient in the second group, and one patient in the third group developed nausea. Preemptive analgesia is proven to reduce postoperative usage of morphine independent of the dosage. We recommend the use of combined celecoxib and pregabalin as preemptive analgesia after the total knee arthroplasty procedure. This trial is registered with NCT03523832 (ClinicalTrials.gov).


QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Shaimaa G Helmy ◽  
Mohammed A El-Kadi ◽  
Mohamed E Elhodiby ◽  
Mohamed H Salama

Abstract Objective This study aims to compare the efficacy and safety of different doses of vaginal misoprostol prior to IUCD insertion among women with nulliparous cervix “those who 29never delivered-vaginally”. Study design: The current study was a randomized, double-blind, placebo-controlled trial conducted in the Family Planning Clinic of Ain Shams University’s Maternity Hospital Egypt. It involved women who delivered only by elective CD (cesarean delivery). One hundred and eighty women were randomized into three groups, Group 1 received misoprostol 200 mcg. Group 2 received misoprostol 100 mcg. Group 3 received placebo. The primary outcome was pain scores which were measured using a visual analogue scale (VAS), the secondary outcome was the ease of insertion score (ES). Results VAS and ES were significantly lower in group 1 compared to group 2 and group 3 (P &lt; 0.001).There was insignificant difference among the three groups as regards successful IUD insertion (P = 0.477). Duration of insertion was significantly lower in group 1 than group 2 (P &lt; 0.001). Satisfaction was significantly higher in group 1 compared to group 2 and group 3 (P &lt; 0.001) Conclusion The effect of misoprostol seems to be dose-dependent. Dose of 200mcg seems to be ideal with best efficacy and with no significant increase in the adverse effects Implications: The dose of 200mcg vaginal misoprostol prior to IUD insertion in women, who had never delivered vaginally before, seems to be the most effective dose. Trail to lower the dose to100mcg significantly compromises the efficacy without remarkable benefit on the side effect profile.


2016 ◽  
Vol 32 (7) ◽  
pp. 488-495 ◽  
Author(s):  
Illymack CF de Araújo ◽  
Elenice Defune ◽  
Luciana PF Abbade ◽  
Hélio A Miot ◽  
Matheus Bertanha ◽  
...  

Objectives Compare the efficacy and safety of fibrin gel to 8% papain gel for wound dressing of venous ulcers. Method Patients with chronic venous ulcers were randomly assigned to one in three groups: Group 1—fibrin gel; Group 2—8% papain gel; Group 3—carbopol gel (control). Patients were seen every 15 days during 2 months, verifying reduction of the ulcer area, local infection, exudation, and epithelization. All serious or nonserious adverse events were recorded. Results Fifty-five patients (total of 63 ulcers) were randomly distributed in three groups (G1 = 21; G2 = 19; G3 = 23). No patient was excluded or discontinued treatment throughout the study. The areas of the ulcers were similarly reduced in all groups (14.3%, 21.1%, and 30.4% in groups 1, 2, and 3, respectively), and all had significant reduction in exudation and contamination. Conclusion The data demonstrate that neither fibrin gel nor papain gel were able to improve the process of ulcer-healing, as compared to control.


2010 ◽  
Vol 17 (02) ◽  
pp. 318-324
Author(s):  
AZMAT RIAZ ◽  
HAMID SAEED MALIK ◽  
BILAL YASIN

Objectives: To compare the benefits and adverse effects of three different drug combinations when used for single-shot epidural anaesthesia for day-case arthroscopy. Design of Study: Prospective, random, double-blind study. Setting: A 250 bedded secondary care hospital. Period: From October 2005 to Feb 2007. Material and Methods: We studied 75 adult male patients, aged between 23 to 63 years, weight <100 kg, ASA physical status I or II undergoing elective knee arthroscopy as day-case procedure. Patients were randomly divided into three groups ( 25 patients in each group) and single-shot epidural anaesthesia was performed using a total of 20 ml epidural lignocaine 2% (Group 1) bupivacaine 0.5% (Group 2) or a mixture containing lignocaine 2% and bupivacaine 0.5%, 10 ml each (Group 3). Results: Time to achieve maximum height (in minutes) was similar in group-1 and group-3 (10±4 and 11±2), but it was significantly longer in group-2 (20±3). Block time was comparable in group-2 and 3 (130±25 and 118±37) but it was significantly shorter in group-1 (60±20). Post-operative discharge time was longest in the group-2, and comparable in group-1 and 3.The incidence of complications like bradycardia, hypotension, nausea and vomiting were more in group-2 and less in group-1 and group-3. Inadequate anaesthesia was more in group-1 and least in other two groups.Four patients of group-1 needed rescue analgesia and two from same group needed general anaesthesia as compared to none in group-2 and group-3. In 4-point patient satisfaction scale, maximum patients from Group-3 rated it perfect while most patients from group-1 were not satisfied with the quality of anaesthesia. Conclusions: The results of our study show that a 50-50 mixture of lignocaine and bupivacaine withfentanyl 50 μg when used for single-shot epidural anaesthesia for day case knee arthroscopy, provides better quality of analgesia, with fewer incidences of side effects and more patient satisfaction as compared to lignocaine or bupivacaine alone.


2018 ◽  
Vol 2018 ◽  
pp. 1-5
Author(s):  
Jagdeep Sharma ◽  
Ruchi Gupta ◽  
Anita Kumari ◽  
Lakshmi Mahajan ◽  
Jasveer Singh

Aim. There are limited data comparing levobupivacaine, ropivacaine, and bupivacaine in paediatric patients. So, this study was performed to evaluate the caudal effectiveness of all the three drugs in paediatric patients undergoing infraumbilical surgeries and associated complications with these drugs. Material and Methods. 90 patients of ASA grade I and II posted for elective infraumbilical surgeries were randomly divided into three groups of 30 each. A standardized anaesthetic protocol was used. Patients received 0.25% levobupivacaine in group 1, 0.25% ropivacaine in group 2, and 0.25% bupivacaine in group 3. The effectiveness of block was assessed using caudal effectiveness score. Postoperative pain relief was assessed with modified Hannallah pain score. Haemodynamic parameter monitoring was done. The duration of analgesia and associated complications were studied. Statistical analysis was done using the chi-square test for nonparametric data. Parametric data were analysed using ANOVA for intergroup comparison and Tukey’s HSD for intragroup comparison. Results. Demographic data were comparable. Haemodynamic parameters remained within normal range. Mean caudal effectiveness score in all the three groups was statistically insignificant (p>0.05). The duration of analgesia provided by bupivacaine (145.31 ± 26.17 min) was longer than levobupivacaine (126.15 ± 15.15 min) and ropivacaine (114.68 ± 11.32 min) (p<0.01). Mean postoperative pain scores were lower in group 3 as compared to group 1 and group 2. Conclusion. We conclude that levobupivacaine and ropivacaine provide similar intraoperative quality with minimal haemodynamic variability and shorter duration of postoperative analgesia without any significant complications when compared with racemic bupivacaine. This trial is registered with CTRI/2018/03/012402.


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