Dexamethasone/ Erector Spinae Plane Block Analgesia in Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-31

Study Completion Date

2023-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone/ Erector Spinae Plane Block

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

Group Type ACTIVE_COMPARATOR

Dexamethasone/ Erector Spinae Plane Block

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Erector Spinae Plane Block

Intervention Type DRUG

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

Interventions

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Dexamethasone/ Erector Spinae Plane Block

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No