Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy
1 other identifier
interventional
110
1 country
1
Brief Summary
Postoperative abdominal and shoulder pain that are experienced in patients undergoing laparoscopic cholecystectomy (LC) is significant. Although it is generally less sever than post open cholecystectomy pain, it still causes an avoidable distress in the first 24 hours postoperatively
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2020
Shorter than P25 for not_applicable
1 active site
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
September 3, 2020
CompletedStudy Start
First participant enrolled
October 24, 2020
CompletedFirst Posted
Study publicly available on registry
October 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2021
CompletedAugust 30, 2021
August 1, 2021
4 months
September 3, 2020
August 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative level of ACTH hormone
a stress marker that increase with pain and surgery
6 hours
Secondary Outcomes (1)
VISUUEAL ANALOGE SCORE
24 hours
Study Arms (4)
bupivacaine group
ACTIVE COMPARATORbupivacaine + morphine
ACTIVE COMPARATORbupivacaine + morphine + ketamine
ACTIVE COMPARATORisotonic saline
PLACEBO COMPARATORInterventions
instillation of local anaesthetic in the abdominal cavity at the end of the procedure
instillation of local anaesthetic in the abdominal cavity at the end of the procedure
instillation of local anaesthetic + morphine sulfate in the abdominal cavity at the end of the procedure
instillation of local anaesthetic + morphine sulfate + ketamine in the abdominal cavity at the end of the procedure
Eligibility Criteria
You may qualify if:
- Patients scheduled for Laparoscopic cholecystectomy.
- Age spectrum of 18 - 55 years
- ASA I, II
- Have no comorbid chronic medical diseases
You may not qualify if:
- Patients with co morbid medical diseases
- Age outside the specified range
- Acute inflammation of the gall bladder
- Critically ill patient
- Emergency operations
- Patient refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University Hospitals
Asyut, 71515, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- consultant
Study Record Dates
First Submitted
September 3, 2020
First Posted
October 30, 2020
Study Start
October 24, 2020
Primary Completion
March 1, 2021
Study Completion
March 30, 2021
Last Updated
August 30, 2021
Record last verified: 2021-08