Comparison of analgesic efficacy of ultrasound guided erector spinae plane block with port site infiltration in laparoscopic cholecystectomy: A SINGLE BLIND randomized controlled trial.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Govt Medical College
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- a. Hemodynamic profile (heart rate and mean blood pressure) in the intraoperative period
Overview
Brief Summary
Laparoscopic cholecystectomy is the standard treatment for gallstone disease, yet many patients still experience moderate-to-severe postoperative pain. Opioid-based analgesia, though effective, is limited by side effects such as respiratory depression, nausea, vomiting, and delayed recovery, making multimodal, opioid-sparing strategies preferable. The erector spinae plane block (ESPB), first described in 2016, has shown promising results in thoracic and upper abdominal surgeries, but evidence in laparoscopic cholecystectomy remains limited. This randomized controlled trial aims to evaluate the analgesic efficacy of ESPB combined with port-site infiltration compared with port-site infiltration alone in adult patients undergoing laparoscopic cholecystectomy. Patients will be randomly assigned to receive either ultrasound-guided ESPB at the T7–T8 level with port-site infiltration or port-site infiltration alone, with standardized general anesthesia and non-opioid analgesia in both groups. The primary outcome is the time to first rescue analgesia within 24 hours, with intraoperative fentanyl consumption as a key secondary outcome. Additional endpoints include postoperative opioid use, pain scores, incidence of postoperative nausea and vomiting, recovery quality, and block-related complications. Approximately ninety-two patients will be enrolled to detect a clinically significant difference with adequate power. By assessing whether ESPB can reduce perioperative opioid requirements and prolong postoperative analgesia, this study seeks to establish its role in enhancing multimodal pain management for laparoscopic cholecystectomy. Our research hypothesis will be Ultrasound guided erector spinae block may reduce the requirement of intraoperative fentanyl consumption and increase the time of 1st rescue analgesic dose.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •American Society of Anesthesiologists Physical Status I and II b.
- •Age between 18 and 60 years old undergoing laparoscopic cholecystectomy.
Exclusion Criteria
- •refusal for regional anaesthesia b.
- •patient having infection at site of injection c.
- •patients having coagulopathy and platelet count less than 1 lakh per cmm d.
- •patients with a known allergy to local anaesthetics.
- •pregnancy, f.
- •body mass index more than 35 kg per m2, g.
- •chronic pain h.
- •hepatic or renal dysfunction( Srerum creatinine more than 1.2 ;liver enzymes exceeding normal limit).
Outcomes
Primary Outcomes
a. Hemodynamic profile (heart rate and mean blood pressure) in the intraoperative period
Time Frame: Intra-operatively every 10 minutes and post-operatively every 30 minutes till the patient is shifted to the ward and then every hourly for the next 24 hours
b. Mean total dose of fentanyl during the intraoperative period during laparoscopic cholecystectomy
Time Frame: Intra-operatively every 10 minutes and post-operatively every 30 minutes till the patient is shifted to the ward and then every hourly for the next 24 hours
c. Time to requirement of first rescue analgesic (inj Diclofenac 75mg iv) when VAS score more than 4.
Time Frame: Intra-operatively every 10 minutes and post-operatively every 30 minutes till the patient is shifted to the ward and then every hourly for the next 24 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Nairita Mayur
College of Medicine & Sagore Dutta Hospital