Magnesium Sulfate for TAP Analgesia During Laparoscopic Cholecystectomy
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Magnesium Sulfate
bupevecaine
saline
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- ASA I, II for lap cholecystectomy
Exclusion Criteria:
- ASA III, IV
Sites / Locations
- Mansoura university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Magnesium sulfate group
B group
C group
Arm Description
US guided TAP with magnesium sulfate
TAP bupevecaine
control TAP saline
Outcomes
Primary Outcome Measures
analgesia after laparoscopic cholecystectomy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02533284
Brief Title
Magnesium Sulfate for TAP Analgesia During Laparoscopic Cholecystectomy
Official Title
Magnesium Sulfate for TAP Analgesia During Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study the effect of adding Magnesium sulfate to TAP block in analgesia after laparoscopic cholecystectomy.
Detailed Description
After approval of local ethical committee, consent will be obtained from 90 patients scheduled for laparoscopic cholecystectomy in GEC center, Mansoura University, Egypt. Patients will be of either ASA I and II, with Age ranging from 18-40 years, and BMI less than 35. Patients will be randomized into 3 groups (using closed envelope technique in blocks of 18); Controlled group (C group), Bupivacaine group (B group), Bupivacaine Magnesium group (M group).
Anesthesia induction will be the same in the three groups (Propofol 1-1.5mglkg, Fentanyl 1 mic/kg, Atracrium 0.5 mg/kg) then Sevoflorane inhalational anesthesia for maintainace in 0.4 oxygen/air mixtures.
In both M group and B group, preemptive US guided Subcostal TAP block (Toshiba Xario, Japan) was performed on both sides using 20 ml volume (0.25 Bupivacaine in B group or 0.25 Bupivacaine plus 0.5 gm MgSo4 in M group). Surgical sterilization will be started 5 minutes after the block and surgery started5 minutes later. Hemodynamic data (HR, MAP) will be collected immediately after induction, at start of surgery, and each 10 minutes later.
At the end of surgery, and after closure of surgical ports, anesthesia was terminated and extubation done when patients fulfilled the required criteria. Postoperative hemodynamic data (HR, MAP), VAS, and PONV will berecorded at 0, 1, 2, 6, 12, 24 hours after surgery, Ramsay sedation was recorded at 0, 1, 2, 6 hours postoperatively. Boluses of Morphine (0.02 mg/kg) will be given whenever VAS ≥4.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Magnesium sulfate group
Arm Type
Experimental
Arm Description
US guided TAP with magnesium sulfate
Arm Title
B group
Arm Type
Experimental
Arm Description
TAP bupevecaine
Arm Title
C group
Arm Type
Placebo Comparator
Arm Description
control TAP saline
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
Group 1
Intervention Description
preemptive US guided TAP block will be done using Bupivacaine 0.25% plus 0.5 gm MgSo4 in M group).
Intervention Type
Drug
Intervention Name(s)
bupevecaine
Other Intervention Name(s)
group 2
Intervention Description
US guided TAP using Bupevecaine 0.25 %
Intervention Type
Drug
Intervention Name(s)
saline
Other Intervention Name(s)
group3
Intervention Description
US guided TAP using placebo (saline)
Primary Outcome Measure Information:
Title
analgesia after laparoscopic cholecystectomy
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I, II for lap cholecystectomy
Exclusion Criteria:
ASA III, IV
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alrefaey Kandeel, MD
Phone
00201008158591
Email
refa3ey2@yahioo.com
Facility Information:
Facility Name
Mansoura university
City
Mansoura
State/Province
Dkahleya
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alreafey Kandeel, MD
Phone
00201008158591
Email
refa3ey2@yahoo.com
12. IPD Sharing Statement
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Magnesium Sulfate for TAP Analgesia During Laparoscopic Cholecystectomy
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