Comparison Of Post-Operative Recovery In Single Puncture Subcostal Transversus Abdominis Plane And Rectus Sheath Block With Erector Spinae Plane Block In Patients Undergoing Laparoscopic Cholecystectomy-A Randomized Controlled Study.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- To compare the Quality of recovery after single puncture subcostal transversus abdominis plane and
研究概览
简要总结
Laparoscopic cholecystectomy is considered the gold standard of therapy for symptomatic cholelithiasis
and despite recent advances, majority of the patients still experience poor quality of recovery and pain in
the postoperative period. Untreated postoperative pain has many consequences, including patient
dissatisfaction, transition into chronic pain, delayed discharge from the hospital and increased healthcare
costs. This study aims to compare the post-operative quality of recovery in unilateral Erector Spinae
Block (ESB) versus unilateral single puncture subcostal transversus abdominis plane block and Rectus
sheath block. The study utilizes ropivacaine due to its reversible inhibition of nerve impulses, resulting
in prolonged sensory blockade at lower doses and fewer side effects like cardio-toxicity. Real-time
ultrasound is employed for precise imaging of abdominal wall muscular layers, ensuring accurate needle
placement and local anaesthetic injection, enhancing the efficacy and safety of the block.
The study employs the Quality of Recovery-15 (QoR-15 H), a validated patient-reported outcome
measure, to assess postoperative quality of recovery. This measurement has been found valid, reliable,
and responsive in surgical patients, meeting the requirements for outcome measurement instruments in
clinical trials.
This study also evaluates the duration of postoperative analgesia based on the demand for the, first rescue
analgesia, reduction in total doses of postoperative rescue analgesia, pain scores, and potential side effects
and complications.
Patient will be randomly divided into two groups with 50 patients in each group. Group ES will receive
30 ml of 0.25% isobaric ropivacaine unilaterally in plane below the erector spinae muscle before starting
of surgery. Group TR will receive 20ml of 0.25 % isobaric ropivacaine, unilaterally into plane between
the transversus abdominis and internal oblique muscles and 10ml of 0.25%isobaric ropivacane into plane
between rectus muscle and posterior rectus sheath before starting of the surgery.
Patient will be observed for quality of recovery and duration of postoperative analgesia by time to first
rescue analgesic after ultrasound guided Erector spinae plane block or subcostal transversus abdominis
plane and rectus sheath block in laparoscopic cholecystectomy. The Quality of recovery will be assessed
in patients using QoR-15 H score at 24 hrs, requirement of rescue analgesics in the first 24 hours
postoperatively, the hemodynamic changes perioperatively, any side effects in both the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient posted for Laparoscopic cholecystectomy under general anaesthesia Patient in the age group 18-65 years, of any gender Patients with American society of Anaesthesiologists physical status I or II.
排除标准
- •Patient’s refusal to participate in the study.
- •History of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic diseases.
- •Patient with any coagulopathy.
- •History of allergy to drugs under study.
- •Infection at regional block site.
- •Patients inability to understand QOR-15 questionnaire.
结局指标
主要结局
To compare the Quality of recovery after single puncture subcostal transversus abdominis plane and
时间窗: 24 hours
rectus sheath block versus erector spinae plane block in patients undergoing laparoscopic
时间窗: 24 hours
cholecystectomy under general anaesthesia.
时间窗: 24 hours
次要结局
- To compare the analgesic requirements in the 1st 24-hours post-operative period in terms of pain scores,(times of first rescue analgesic dosage, & total analgesic consumption in both the groups.)
研究者
NAVNEET
BPS GMC KHANPUR KALAN SONIPAT
