scholarly journals Evaluation of postoperative analgesic efficacy and perioperative hemodynamic changes with low dose intravenous dexmedetomidine infusion in patients undergoing laparoscopic cholecystectomy – A randomised, double-blinded, placebo-controlled trial

2020 ◽  
Vol 36 (1) ◽  
pp. 72
Author(s):  
GeetanjaliT Chilkoti ◽  
Ganeshan Karthik ◽  
Rajesh Rautela
Author(s):  
Danielle M. Panelli ◽  
Deirdre J. Lyell

“CLASP: A Randomized Trial of Low-Dose Aspirin for the Prevention and Treatment of Preeclampsia Among 9364 Pregnant Women” was a double-blinded, placebo-controlled trial that evaluated the impact of antenatal aspirin administration on development of preeclampsia and intrauterine growth restriction (IUGR). A total of 9364 women either at risk for preeclampsia or currently experiencing preeclampsia or IUGR were enrolled between 12 and 32 weeks and randomized to receive 60mg aspirin daily or placebo. While a nonsignificant 12% reduction in the odds of preeclampsia was found among the entire cohort, the reduction in preeclampsia with aspirin use was more pronounced for those who began prophylaxis prior to 20 weeks (22% reduction, p = 0.06). There was also a lower risk of preterm birth before 37 weeks in those who received aspirin at any time (19.7% vs. 22.2%, p = 0.003) but no difference in IUGR infants. In conclusion, 60mg aspirin daily did not significantly reduce the risk of preeclampsia or IUGR among the women included in this study.


2019 ◽  
Vol 37 (6) ◽  
pp. 1118-1123 ◽  
Author(s):  
Seyed Mohammad Hosseininejad ◽  
Fatemeh Jahanian ◽  
Salman Erfanian Irankar ◽  
Mahmood Moosazadeh ◽  
Seyed Adel Hosseini ◽  
...  

2020 ◽  
Vol 45 (10) ◽  
pp. 767-773
Author(s):  
Zachary L. McCormick ◽  
Taylor Burnham ◽  
Shellie Cunningham ◽  
Richard W Kendall ◽  
David Bougie ◽  
...  

BackgroundLow-dose lidocaine is a common diluent for analgesia following cervical interlaminar epidural steroid injection (CIESI). Concerns with this practice exist. A single-arm cohort reported that 20% of patients develop postprocedural upper extremity weakness when using lidocaine as a diluent. Furthermore, a high-cervical spinal block with unintended intrathecal or subdural administration is possible.ObjectiveDetermine if low-dose lidocaine as a diluent during CIESI causes clinically meaningful (1) upper extremity weakness and (2) immediate pain relief when compared with saline.DesignDouble-blinded randomized control trial.MethodsPatients with cervical radicular pain scheduled for CIESI were enrolled. Participants received lidocaine (CIESI-L) or saline (CIESI-S) as a diluent for the epidural injectate. Myotomal strength was measured with dynamometry before and between 20 and 30 min after CIESI. Pre-pain and post-pain scores were obtained. Primary and secondary outcomes were post-CIESI weakness of ≥20% (minimal clinically important difference (MCID)) in >1 myotome and ≥50% pain reduction on the numerical scale.Results120 participants (64 females (53%), mean age, 56 (SD 13.7) years) completed the study and were analyzed (CIESI-L n=60; CIESI-S n=60). There was no significant between-group difference in the proportion of participants with postprocedural weakness, CIESI-L 41.7% (95% CI, 29.8% to 54.5%), CIESL-S 50% (95% CI, 37.5% to 62.5%). Between-group comparison showed no significant difference in pain reduction, relative risk 1.53 (95% CI, 0.82 to 2.86).ConclusionLow-dose lidocaine as a diluent in CIESI does not significantly increase the risk of post-CIESI myotomal weakness when compared with saline, but also does not substantially increase the likelihood of immediate, meaningful pain relief.Trial registration detailsClinicalTrials.gov (NCT03127137); December 26, 2017.


2020 ◽  
Vol 48 (3) ◽  
pp. 588-598 ◽  
Author(s):  
Jaime R. Garza ◽  
Richard E. Campbell ◽  
Fotios P. Tjoumakaris ◽  
Kevin B. Freedman ◽  
Lawrence S. Miller ◽  
...  

Background: Currently, there are limited nonoperative treatment options available for knee osteoarthritis (OA). Cell-based therapies have emerged as promising treatments for knee OA. Autologous stromal vascular fraction (SVF) has been identified as an efficient medium for intra-articular administration of progenitor cells and mesenchymal stem cells derived from adipose tissue. Hypothesis: Patients receiving intra-articular SVF would show significantly greater improvement than patients receiving placebo injections, and this improvement would be dose dependent. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This was a multisite prospective double-blinded randomized placebo-controlled clinical trial. Adult patients with symptomatic knee OA were eligible. Thirty-nine patients were randomized to high-dose SVF, low-dose SVF, or placebo (1:1:1). SVF was obtained via liposuction, processed to create the cellular implant, and injected during the same clinical visit. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores and magnetic resonance images were obtained preoperatively and at 6 and 12 months after injection. The Wilcoxon rank sum nonparametric test was utilized to assess statistical significance, and the Hodges-Lehmann location shift was used to assess superiority. Results: The median percentage change in WOMAC score at 6 months after injection for the high-dose, low-dose, and placebo groups was 83.9%, 51.5%, and 25.0%, respectively. The high- and low-dose groups had statistically significant changes in WOMAC scores when compared with the placebo group (high dose, P = .04; low dose, P = .02). The improvements were dose dependent. The median percentage change in WOMAC score from baseline to 1 year after injection for the high-dose, low-dose, and placebo groups was 89.5%, 68.2%, and 0%, respectively. The high- and low-dose groups displayed a greater percentage change at 12 months when compared with the placebo group (high dose, P = .006; low dose, P = .009). Magnetic resonance image review revealed no changes in cartilage thickness after treatment. No serious adverse events were reported. Conclusion: Intra-articular SVF injections can significantly decrease knee OA symptoms and pain for at least 12 months. The efficacy and safety demonstrated in this placebo-controlled trial support its implementation as a treatment option for symptomatic knee OA. Registration: NCT02726945 (ClinicalTrials.gov identifier)


Author(s):  
Priyanka Thakur ◽  
Prteet Negi ◽  
Ajay Sood ◽  
Aparna Sharma

Background: To compare the recovery in ketofol (ketamine and   propofol) with propofol alone for vas in   patients undergoing laparoscopic cholecystectomy Methods: Prospective, randomized, double blinded controlled trial. After approval by the research ethics committee and written informed valid consent of the patients, the proposed study was carried out for a period of one year in 60  patients , in ASA-I and ASA-II patients, aged between 19 to 60 years of either sex, who were  posted for laproscopic cholecystectomy surgery at Indira Gandhi Medical College, Shimla. Results: Recovery profile was statistically significant for two groups. In group P after stopping infusion ,mean time for eye opening was 8.27 ± 1.28 which was less than group K ( 12.53 ± 1.48).  Mean time of response to verbal command in group P(8.4 ± 1.19) was less than group K (12.5 ± 1.46) and mean time of extubation in group P (9.5 ± 1.25) was also less than group K (14.33 ± 1.52). Conclusion- Patients of Group P after stopping of infusion took less time for eye opening, obeying verbal command and also less time for extubation  in comparison to group K . Keywords: Recovery, Propofol, Ketamine


2018 ◽  
pp. annrheumdis-2018-214104 ◽  
Author(s):  
Elien A M Mahler ◽  
Michiel JM Minten ◽  
Mathilde M Leseman-Hoogenboom ◽  
Philip M P Poortmans ◽  
Jan Willem H Leer ◽  
...  

ObjectivesLow-dose radiation therapy (LDRT) for benign disorders such as knee osteoarthritis (OA) is widely used in some parts of the world, despite absence of controlled studies. We evaluated the effect of LDRT on symptoms and inflammation in patients with knee OA.MethodsIn this randomised, double-blinded, sham-controlled clinical trial (RCT), we recruited patients with knee OA (clinical ACR criteria) in the Netherlands, aged ≥50 years, pain score ≥5/10 and non-responding to analgesics and exercise therapy. Patients were randomised 1:1 to receive LDRT (1 Gray per fraction) or sham intervention six times in 2 weeks, stratified by pain (<8 versus ≥8/10). Primary outcome was the proportion of OMERACT-OARSI responders, 3 months postintervention. Secondary outcomes included pain, function and inflammatory signs assessed by ultrasound, MRI and serum inflammatory markers.ResultsWe randomly assigned 55 patients: 27 (49%) to LDRT and 28 (51%) to sham. At 3 months postintervention, 12/27 patients (44%; 95%  CI 26% to 63%) in the LDRT vs 12/28 patients (43%; 95%  CI 25% to 61%) in the sham group responded; difference 2% (95% CI 25% to 28%), OR adjusted for the stratifying variable was 1.1 (95% CI 0.4 to 3.2). Also, for clinical and any of the inflammatory signs, no differences were observed.ConclusionsWe found no substantial beneficial effect on symptoms and inflammatory signs of LDRT in patients knee OA, compared with sham treatment. Therefore, based on this RCT and the absence of other high-quality evidence, we advise against the use of LDRT as treatment for knee OA.Trial registration numberNTR4574.


2005 ◽  
Vol 71 (10) ◽  
pp. 827-829 ◽  
Author(s):  
Rob Schuster ◽  
David Stewart ◽  
Lynn Schuster ◽  
Gregory Greaney ◽  
Kenneth Waxman

Cyclooxygenase-2 (COX-2) inhibitors are a class of drugs that may avoid some of the side effects of narcotics and nonsteroidal anti-inflammatory drugs (NSAIDs). We performed a randomized, double-blinded, placebo-controlled trial giving a single oral dose of the COX-2 inhibitor rofecoxib 25 mg or placebo preoperatively to determine the impact upon postoperative pain, complications, narcotic use, and hospital stay after laparoscopic cholecystectomy. Investigators and patients were blinded. Pain was measured on a 10-point visual analogue scale. Eighty patients were randomized: 40 to the rofecoxib group and 40 to the placebo group. The amount of pain between the two groups postoperatively was equivalent. Pain was recorded at 1 hour, 4.03 ± 1.93 in the rofecoxib group versus 4.38 ± 1.34 in the placebo group ( P = 0.36); at 6 hours, 3.00 ± 1.12 in the rofecoxib group versus 2.78 ± 0.78 in the placebo group ( P = 0.42); and at 24 hours, 1.64 ± 0.67 in the rofecoxib group versus 2.68 ± 1.90 in the placebo group ( P = 0.17). The amount of pain medication received and lengths of hospital stay was not significantly different between the two groups. Our data demonstrate no significant benefit of preoperative oral rofecoxib in patients undergoing laparoscopic cholecystectomy.


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