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临床试验/CTRI/2023/11/059968
CTRI/2023/11/059968尚未招募1/2 期

Comparing erector spinae plane block with serratus anterior plane block for Coronary Bypass Graft Surgery

MANDAR GALANDE1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年11月20日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
OPIOID REQUIREMENT

研究概览

简要总结

TITLE - Comparingerector spinae plane block with serratus anterior plane block for CoronaryBypass Graft Surgery. 

Background - Coronaryartery bypass grafting surgery is done in those patients who are havingmultiple blockages in the coronary arteries or in those patients angioplasty isnot possible. ForCABG thoracotomy has to be performed which causes significant pain intra aswell as post operatively. Erector spinae plane (ESP) block and serratus anterior plane (SAP) blockpromise effective thoracic analgesia compared with systemically administeredopioids. Needs to be compared in terms ofreduction in the opioids requirement during the surgery plus quality ofrecovery and overall morbidity after thoracic surgery.

Aim-  To compare the reduction ofthe opioids and to assess the quality of recovery and morbidity between ESB ( Erector spinae planeblock) and SAP (Serratus anterior plane)block

primary Objectives - Toassess the intra and post operative opioids requirement in erector spinae planeblock versus serratus anterior plane block in patients undergoing CABG.

Secondary Objectives - Toassess post-op complication using comprehensive complication index calculator and To assess qualityof recovery as per QoR-15 Scale after CABG in ESP AND SAP block patients.

Selection criteria - InclusionCriteria- 1. Elective Cardiac Surgeries UndergoingGeneral Anaesthesia.2: Age Between 18 To 80 3:Asa Grade 1 To 3 ExclusionCriteria- 1: Patient Refused To Give Consent ForStudy. 2: Patient Having Infections At BlockSite. 3: Contraindication to RegionalAnesthesia – preexisting coagulopathy, known local anesthetic sensitivity etc. 4: History Of Opiate Abuse 5: Pre- Existing Chronic Pain OrCognitive Dysfunction.

Materials Metods - •Studydesign - prospective randomized, observational study â€¢Duration-  4 to 8 months.

•Studygroups – a) ESP – erector spinae plane block. b) SAP – serratus anterior planeblock

•Levobupivacaine0.25% 20ml on each side given in both the blocks.

•Opioidsrequirement during the surgery and in the post op period will be noted as per haemodynamicparameters

•Qualityof recovery will be assessed using the quality of recovery-15 (qor-15) scale at24 h postoperatively.

•Consent- Informed consent will be obtained prior to surgery.

•Group size - calculated using power analysis based on a previous study report.

sample size - InDylan T. Finnerty et al in 2020.primaryoutcome was the QoR-15 score at 24 h postoperatively. The established minimumclinically important difference in QoR-15 is 8.0, and  SD ofQoR-15 scores after major surgery is in the order of 16 (range of QoRscore is 1–150).Therefore,assuming Type I error=0.05 and Type II error=0.2 (80% power to detect thisdifference), and using Power method  -Comparison of two means. Minimumestimated sample size was 82 (41 in each group), we will therefore include 90patients (45 per group) to in accordance to the pre-specified selectioncriteria.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1: Elective Cardiac Surgeries Undergoing General Anaesthesia.
  • 2: Age Between 18 To 80 3: Asa Grade 1 To 3.

排除标准

  • 1: Patient Refused To Give Consent For Study.
  • 2: Patient Having Infections At Block Site.
  • 3: Contraindication to Regional Anesthesia – preexisting coagulopathy, known local anesthetic sensitivity etc.
  • 4: History Of Opiate Abuse 5: Pre- Existing Chronic Pain Or Cognitive Dysfunction.

结局指标

主要结局

OPIOID REQUIREMENT

时间窗: DURING OPERATION AND POST OP PERIOD

次要结局

  • POST-OP COMPLICATIONS AND QUALITY OF RECOVERY(DURING POST OPERATIVE PERIOD)

研究者

发起方
MANDAR GALANDE
申办方类型
Other [investigator inititated]

研究点 (1)

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