Magnesium Sulfate for TAP Analgesia During Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Study the effect of adding Magnesium sulfate to TAP block in analgesia after laparoscopic cholecystectomy.

Detailed Description
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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.

Official Title
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Magnesium Sulfate for TAP Analgesia During Laparoscopic Cholecystectomy

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: bupevecaine
* Drug: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I, II for lap cholecystectomy Exclusion Criteria: ASA III, IV

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium sulfate group<br>US guided TAP with magnesium sulfate | Drug: Magnesium Sulfate<br>* preemptive US guided TAP block will be done using Bupivacaine 0.25% plus 0.5 gm MgSo4 in M group).<br>* Other names: Group 1;Drug: bupevecaine<br>* US guided TAP using Bupevecaine 0.25 %<br>* Other names: group 2;|
| Experimental: B group<br>TAP bupevecaine | Drug: bupevecaine<br>* US guided TAP using Bupevecaine 0.25 %<br>* Other names: group 2;|
| Placebo Comparator: C group<br>control TAP saline | Drug: saline<br>* US guided TAP using placebo (saline)<br>* Other names: group3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesia after laparoscopic cholecystectomy |  | 24 hours |