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
• Status: Not yet recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

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