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NCT05105997 Clinical Trial

Dexamethasone/ Erector Spinae Plane Block Analgesia in Laparoscopic Cholecystectomy

Post Operative Pain Clinical Trial

Official title:
Dexamethasone as a Bupivacaine Adjuvant in Ultrasound-guided Erector Spinae Plane Block for Patients Undergoing Laparoscopic Cholecystectomy: a Randomized Double-blind Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05105997
Other study ID # SM 10 2021
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date December 2022
Est. completion date July 2023

Study information
Verified date September 2022
Source Assiut University
Contact Seham M Moeen, MD
Phone 01006386324
Email seham.moeen@aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date July 2023
Est. primary completion date July 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• 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
Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and one ml of normal saline 15 minutes before skin incision.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary The intensity of postoperative pain Assessed by the verbal analog pain scale graded from 0 to 10 (0 = no pain, and 10 = the worst possible pain) 24 hours after surgery
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