Dexamethasone/ Erector Spinae Plane Block Analgesia in Laparoscopic Cholecystectomy

Phase 2

Not yet recruiting

• Conditions: Post Operative Pain
• Interventions: Drug: Dexamethasone/ Erector Spinae Plane Block; Drug: Erector Spinae Plane Block

• Registration Number: NCT05105997
• Lead Sponsor: Assiut University

Brief Summary

Although considered a minimally invasive procedure, laparoscopic cholecystectomy (LC) frequently results in moderate to severe immediate postoperative pain.

Detailed Description

Although considered a minimally invasive procedure, laparoscopic cholecystectomy (LC) frequently results in moderate to severe immediate postoperative pain. In addition to predominant visceral pain, nearly half of all patients suffer from shoulder pain in the early postoperative period. The most likely reason is sub-diaphragmatic irritation, which is transmitted by the phrenic nerve, causing referred pain in the C4 dermatome. Due to multiple sources of pain, multimodal analgesia approaches have been used in the perioperative period following LC.

Study Timeline

• Study First Submitted: 2021-10-23
• Study First Submitted QC: 2021-10-23
• Study First Posted: 2021-11-03
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-21
• Last Update Posted: 2022-09-23
• Study Start: 2022-12
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients undergoing elective LC under general anesthesia, ASA status I-II, aged from 18 to 65 years old of both sex

Exclusion Criteria

• Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis)
• Altered conscious level
• Pregnancy
• Body mass index (BMI > 35)
• Advanced hepatic or renal failure
• Chronic opioid consumption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone/ Erector Spinae Plane Block	Dexamethasone/ Erector Spinae Plane Block	Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and dexamethasone 15 minutes before skin incision.
Erector Spinae Plane Block	Erector Spinae Plane Block	Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and one ml of normal saline 15 minutes before skin incision.

Primary Outcome Measures

Name	Time	Method
The intensity of postoperative pain	24 hours after surgery	Assessed by the verbal analog pain scale graded from 0 to 10 (0 = no pain, and 10 = the worst possible pain)