COMPARISON OF ULTRASOUND GUIDED ERECTOR SPINAE PLANE BLOCK (PAIN RELIEF TECHNIQUE) PERFORMED WITH DIFFERENT CONCENTRATIONS OF MEDICINE (BUPIVACAINE) FOR POST SURGERY PAIN SEVERITY, SURGICAL STRESS AND SATISFACTION IN PATIENTS UNDERGOING GALL BLADDER REMOVAL (LAPAROSCOPIC CHOLECYSTECTOMY) SURGERY.

Completed

• Conditions: Calculus of gallbladder without cholecystitis,

• Registration Number: CTRI/2021/07/034629
• Lead Sponsor: Dr Ali Saloda

Brief Summary

The laparoscopic technique is the standard of care for cholecystectomy surgery. Although considered a minimally invasive procedure, it results in moderate to severe immediate postoperative pain. Postoperative pain consists of both somatic and visceral pain components. In addition to predominant visceral pain, nearly half of all patients suffer from shoulder pain.

Due to multiple sources of pain multimodal analgesia approaches have been used. Narcotic medications like opioids help in reducing somatic and visceral pain but they are associated with increased postoperative nausea and vomiting, ileus, sedation, and delayed hospital discharge.

Blocks like Transverse abdominis plane block and oblique subcostal TAP block only help in reducing the somatic pain and have no effect on the visceral component of pain. As the erector spinae fascia extends from the nuchal fascia cranially to the sacrum caudally, the local anaesthetic drugs extend through several levels, and the block can be effective over a large area.

Better postoperative analgesia, reduced nausea, vomiting and reduced surgical stress is expected to enhance the recovery of patients after surgery and lead to greater patient satisfaction. So our study intends to find out the effectiveness of USG-ESPB using different concentrations of bupivacaine on postoperative pain management, reducing perioperative surgical stress and improving patient satisfaction in patients undergoing laparoscopic cholecystectomy.

The procedure shall be performed after inducing general anaesthesia to the patient for surgery. Following intubation, the patient shall be placed in a lateral position and USG guided block shall be given bilaterally at the level of T7 spinous process.

The following parameters shall be recorded in the first 24 hours: NRS score at the surgical site at rest, on movement and on deep breathing at various time intervals, shoulder pain, intraoperative fentanyl requirements, total postoperative analgesic consumption, the incidence of nausea and vomiting and complications related to ESP block. A patient satisfaction survey shall be done on all patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-07
• Study Completion: 2022-01-31
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

All patients aged 18-65yrs, posted for elective laparoscopic cholecystectomy, with American society of Anaesthesiologist (ASA) physical status I-II shall be included in the study.

Exclusion Criteria

• Patient refusal.
• Patients with known allergy to local anaesthetics.
• Patients with presence of bleeding disorders.
• Patients with infection at injection sites.
• Patients with prior addiction or analgesics abuse (opioid and nonsteroidal anti-inflammatory drug medications).
• Patients with BMI <18.5kg/m2 and >34.9kg/m2.
• Patients with weight under 50kgs.
• Patients with history of psychiatric or neurological disease, deafness.
• Patients in whom the total surgical duration exceeds 2 hours (after incision) or surgery is converted to open cholecystectomy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the reduction in Numerical Rating Scale (NRS) score at 30 minutes after extubation between the control group, group receiving ESPB with bupivacaine 0.25% and the group receiving ESPB with bupivacaine 0.375% respectively.	30 minutes after extubation

Secondary Outcome Measures

Name	Time	Method
1. To compare total intraoperative fentanyl requirement in the 3 groups.	2. To compare total analgesic consumption postoperatively in 24 hours between the 3 groups.

Trial Locations

Locations (1)

HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH, HAMDARD NAGAR, DELHI 110062; 🇮🇳 South, DELHI, India

HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH, HAMDARD NAGAR, DELHI 110062

🇮🇳South, DELHI, India

Dr Ali Saloda

Principal investigator

9928297948

ali.saloda@gmail.com