Dexamethasone/ Erector Spinae Plane Block Analgesia in Laparoscopic Cholecystectomy

September 21, 2022 updated by: Seham Mohamed Moeen Ibrahim, Assiut University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Dexamethasone/ Erector Spinae Plane Block
Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and dexamethasone 15 minutes before skin incision.
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
PLACEBO_COMPARATOR: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intensity of postoperative pain
Time Frame: 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)
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2022

Primary Completion (ANTICIPATED)

July 1, 2023

Study Completion (ANTICIPATED)

July 1, 2023

Study Registration Dates

First Submitted

October 23, 2021

First Submitted That Met QC Criteria

October 23, 2021

First Posted (ACTUAL)

November 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM 10 2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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