Dexamethasone/ Erector Spinae Plane Block Analgesia in Laparoscopic Cholecystectomy

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

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.

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

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Dexamethasone/ Erector Spinae Plane Block
* Drug: Erector Spinae Plane Block


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone/ Erector Spinae Plane Block<br>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<br>* Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and dexamethasone 15 minutes before skin incision<br>|
| Placebo Comparator: Erector Spinae Plane Block<br>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<br>* Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and one ml of normal saline 15 minutes before skin incision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |