Dexamethasone/ Erector Spinae Plane Block Analgesia in Laparoscopic Cholecystectomy

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05105997

Enrollment

Registered

2021-11-03

Start date

2022-12-31

Completion date

2023-07-31

Last updated

2022-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

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.

Interventions

DRUGDexamethasone/ Erector Spinae Plane Block

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

DRUGErector 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The intensity of postoperative pain	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)

Contacts

Primary ContactSeham M Moeen, MD

seham.moeen@aun.edu.eg01006386324

Backup ContactGirgis W Alexan, Msc

welsonnet89@gmail.com01200379884

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026