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
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Although considered a minimally invasive procedure, laparoscopic cholecystectomy (LC) frequently results in moderate to severe immediate postoperative pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2022
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2021
CompletedFirst Posted
Study publicly available on registry
November 3, 2021
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedSeptember 23, 2022
September 1, 2022
7 months
October 23, 2021
September 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Dexamethasone/ Erector Spinae Plane Block
ACTIVE COMPARATORPatients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and dexamethasone 15 minutes before skin incision.
Erector Spinae Plane Block
PLACEBO COMPARATORPatients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and one ml of normal saline 15 minutes before skin incision.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients undergoing elective LC under general anesthesia, ASA status I-II, aged from 18 to 65 years old of both sex
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of Anesthesia and Intensive Care
Study Record Dates
First Submitted
October 23, 2021
First Posted
November 3, 2021
Study Start
December 1, 2022
Primary Completion
July 1, 2023
Study Completion
July 1, 2023
Last Updated
September 23, 2022
Record last verified: 2022-09