TAP Block in Laparoscopic Cholecystectomy.
Effect of Magnesium Sulfate When Added to TAP Block With Bupivacaine in Patients Undergoing Laparoscopic Cholecystectomy.
1 other identifier
interventional
60
1 country
1
Brief Summary
Ultrasound-guided transversus abdominis plane block is now widely used in abdominal surgery. Recently, magnesium sulphate is used as adjuvant to local anesthetics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 postoperative-pain
Started Sep 2018
Typical duration for phase_2 postoperative-pain
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
July 19, 2018
CompletedFirst Posted
Study publicly available on registry
August 2, 2018
CompletedStudy Start
First participant enrolled
September 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2019
CompletedDecember 26, 2019
December 1, 2019
1.3 years
July 19, 2018
December 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The postoperative pain
Visual analogue pain score ranging from 0-10 cm where 0 cm = no pain and 10 cm = the worst imaginable pain.
The first 24 hours after surgery
Secondary Outcomes (4)
Time to first dose of post-operative analgesia
First occurrence during hospitalization (up to 24 hours postoperatively)
Postoperative nausea and vomiting
The first 24 hours after surgery
postoperative sedation
The first 24 hours after surgery
Patient satisfaction
At 24 hours after surgery
Study Arms (2)
Bupivacaine +magnesium sulphate
ACTIVE COMPARATORUltrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4.
Bupivacaine only
PLACEBO COMPARATORUltrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).
Interventions
Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4
Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).
Eligibility Criteria
You may qualify if:
- Adult patients (age: 18-65 years old) undergoing laparoscopic cholecystectomy.
You may not qualify if:
- Patient refusal
- Patients with a history of cardiac, or respiratory diseases ( \>ASA III).
- Patients with allergy to amide local anesthetics or medication included in the study.
- Infection at the needle insertion site.
- Pregnancy
- BMI \>35
- Drug abusers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine Assuit University
Asyut, Asyut Governorate, 71516, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- Principal Investigator
Study Record Dates
First Submitted
July 19, 2018
First Posted
August 2, 2018
Study Start
September 3, 2018
Primary Completion
December 15, 2019
Study Completion
December 15, 2019
Last Updated
December 26, 2019
Record last verified: 2019-12