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Dexamethasone/ Erector Spinae Plane Block Analgesia in Laparoscopic Cholecystectomy

Primary Purpose

Post Operative Pain

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Dexamethasone/ Erector Spinae Plane Block

Erector Spinae Plane Block

About this trial

This is an interventional prevention trial for Post Operative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone/ Erector Spinae Plane Block

Erector Spinae Plane Block

Arm Description

Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and dexamethasone 15 minutes before skin incision.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT05105997

First Posted

October 23, 2021

Last Updated

September 21, 2022

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT05105997

Brief Title

Dexamethasone/ Erector Spinae Plane Block Analgesia in Laparoscopic Cholecystectomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2022 (Anticipated)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Pain

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dexamethasone/ Erector Spinae Plane Block

Arm Type

Active Comparator

Arm Description

Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and dexamethasone 15 minutes before skin incision.

Arm Title

Erector Spinae Plane Block

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone/ Erector Spinae Plane Block

Intervention Description

Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and dexamethasone 15 minutes before skin incision

Intervention Type

Drug

Intervention Name(s)

Erector Spinae Plane Block

Intervention Description

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 Measure Information:

Title

The intensity of postoperative pain

Description

Assessed by the verbal analog pain scale graded from 0 to 10 (0 = no pain, and 10 = the worst possible pain)

Time Frame

24 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Seham M Moeen, MD

Phone

01006386324

Ext

seham.moeen@aun.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Girgis W Alexan, Msc

Phone

01200379884

Ext

welsonnet89@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Dexamethasone/ Erector Spinae Plane Block Analgesia in Laparoscopic Cholecystectomy

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