Comparative evaluation of analgesic efficacy of ultrasound guided external oblique intercostal plane block versus port site infiltration in patients undergoing laparoscopic cholecystectomy under general anaesthesia.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr Samiksha Kalra
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Time of first rescue analgesia post operatively
Overview
Brief Summary
Study Title: Comparative evaluation of analgesic efficacy of ultrasound guided external oblique intercostal plane block versus port site infiltration in patients undergoing laparoscopic cholecystectomy under general anaesthesia. Study Type: Interventional, Randomized, Double-Blind, Parallel comparative study
Objective: To compare the analgesic efficacy of ultrasound guided unilateral external oblique intercostal plane block versus local port site infiltration in patients undergoing laparoscopic cholecystectomy under general anaesthesia.
Participants: Adult patients aged 18–65 years, ASA physical status I–II, body mass index 18 - 30 kg/m² scheduled for elective laparoscopic cholecystectomy under general anaesthesia.
Interventions:
- Group A: Patients will receive right sidedultrasound- guided external oblique intercostal plane block using 20 ml of 0.20% ropivacaine after induction of anaesthesia
- Group B: Patients will receive local infiltration at port site using 20 ml of 0.20% ropivacaine after induction of anaesthesia.
Primary Outcome: To evaluate and compare time to first rescue analgesia postoperatively
Secondary Outcomes:
- Hemodynamic parameters intraoperatively at 5, 30, 60, 90 minutes, at the end of surgery and postoperatively at 1, 6, 24 hours
- Intraoperative fentanyl (microgram) requirement
- Postoperative Numerical Rating Scale (NRS) score for pain at rest, deep breathing at 1, 6, 24 hours and on movement at 24 hours
- Total rescue analgesic requirement in first 24 hours
- Patient’s satisfaction score at 6 hours postoperatively
- Incidence of postoperative nausea and vomiting (PONV) in first 24 hours
Sample Size: 50 patients (25 per group) .
**Rationale:**EOIPB is a newer interfascial analgesic technique that anaesthetise lateral as well as anterior cutaneous branches of T6–T10 intercostal nerves and provides better outcomes in reducing postoperative pain and opioid consumption in post laparoscopic cholecystectomy patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Patients belonging to American Society of Anaesthesiologists (ASA) physical status I or II 2 Body mass index 18 to 30 kg/m² 3 Patients undergoing elective laparoscopic cholecystectomy under general anaesthesia.
Exclusion Criteria
- •History of allergy or hypersensitivity to local anaesthetics
- •Infection at the site of needle insertion
- •Pregnant or lactating females
- •Patients with history of narcotic or alcohol addiction
- •Coagulopathy
- •Psychiatric disorders.
Outcomes
Primary Outcomes
Time of first rescue analgesia post operatively
Time Frame: Time of first rescue analgesia within first 24 hours post operatively
Secondary Outcomes
- Hemodynamic Parameters(intraoperatively at 5,30,60 and 90 minutes and at end of surgery)
- Intraoperative fentanyl requirement (in micrograms)
- Numerical rating scale for postoperative pain(at rest, deep breathing (1,6,24 hours))
- Total rescue analgesic requirement in first 24 hours
- Incidence of postoperative nausea and vomitting in first 24 hours postoperatively
Investigators
Dr Samiksha Kalra
ESIC Medical College and Hospital Faridabad