To evaluate bilateral versus unilateral erector spinae plane block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy

Phase 3

Not yet recruiting

Conditions: Cholelithiasis,

Registration Number: CTRI/2024/02/063085

Lead Sponsor: Pt B D Sharma PGIMS Rohtak

Brief Summary: The laparoscopic technique for cholecystectomy surgery has gained popularity in recent years and it is the most commonly performed surgical procedure for benign biliary diseases. Being minimally invasive, it offers advantage of shorter hospital stay, faster recovery, lesser pain and reduced perioperative complications as compared with open techniques performed for biliary diseases.Laparocopic cholecystectomy (LC) produces significant moderate to severe immediate postoperative pain despite being a minimally invasive technique. Furthermore, postoperative pain can affect physical and mental health of the patient and may lead to secondary complications such as nausea, vomiting, slowed bowel movements, muscle spasms, thrombosis, cardiopulmonary complications and delayed recovery of organ function. Perioperative pain management goals are to alleviate suffering, discomfort, early mobilization, rapid recovery, rapid discharge and most importantly patient satisfaction.4 Due to multiple pain sources, multimodal analgesia approaches with non steroidal inflammatory agents, opioids, dexamethasone, gabapentin, local anesthetics infiltration to port sites and regional anesthetic techniques such as epidural, transversus abdominis plane block, erector spinae plane block, oblique subcostal transversus abdominis plane block and paravertebral blocks have been used for pain management in perioperative period following LC.Ultrasound-guided interfascial plane blocks are being commonly used for management of postoperative pain and one of the such novel technique is the USG guided erector spinae plane block (ESPB). USG guided erector spinae plane block has emerged as a well established block for providing perioperative and postoperative analgesia in LC patients.ESPB has shown its value and efficacy in acute as well as in chronic pain management. All blocks will be performed in the sitting position. All the blocks will be performed 20min prior to surgery in sitting position at T8 level in the preoperative room. Under all aseptic precautions, the probe will be placed longitudinally 3 cm lateral to the T8 level. Following identification of the transverse process and erector spinae muscle, the needle will be inserted with in-plane approach from cranial to caudal direction. Confirmation of correct needle tip placement will be done by injecting 5ml saline and visualizing the lifting of the erector spinae muscle away from the transverse process. Twenty milliliter of 0.25% bupivacaine will be then administered on the right side in group U patients and bilaterally at the T8 level in group B patients. The spread of the injectate beneath the erector spinae muscle will be visualized in both the cranial and caudal directions. ESPB will be given bilaterally in patients of group B and unilaterally(right side) in patients of group U. Time at which the block is given will be noted (To).

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 72

Inclusion Criteria

Adult patients of either gender, aged 18-60 years belonging to American society of Anaesthesiologists (ASA) I-II scheduled for elective laparoscopic cholecystectomy under general anaesthesia will be included in the study.

Exclusion Criteria

Patients with : Contraindications to regional anaesthesia such as coagulopathy, infection at the site of puncture etc.
Known history of hypersensitivity/anaphylaxis/contraindications to bupivacaine or its components Pregnancy Mental disorders/o Illness BMI >35kg/m2 Chronic drug/analgesic abuse Refusal to give consent Severe renal or liver diseases Will be excluded from the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare post operative numerical rating scale (NRS) for pain following bilateral versus right sided ESPB in patients undergoing laparoscopic cholecystectomy.	Score at rest and score on coughing at \| 15 min \| 1 hr \| 6 hr \| 24 hr

Secondary Outcome Measures

Name	Time	Method
Duration of postoperative analgesia	Duration of postoperative analgesia (in hours)
Total analgesic consumption in 24hrs	Total analgesic consumption in 24hrs
Postoperative nausea and vomiting	Postoperative nausea and vomiting
Block related complications, if any	Block related complications, if any

Trial Locations

Locations (1): Pt.B D Sharma PGIMS, Rohtak
🇮🇳
Rohtak, HARYANA, India
Pt.B D Sharma PGIMS, Rohtak
🇮🇳Rohtak, HARYANA, India
Dr Urmi Malik
Principal investigator
8607642799
Urmi.malik1997@gmail.com