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Magnesium Sulfate for TAP Analgesia During Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT02533284
Recruitment Status : Unknown
Verified August 2015 by AlRefaey Kandeel, Mansoura University.
Recruitment status was:  Not yet recruiting
First Posted : August 26, 2015
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
AlRefaey Kandeel, Mansoura University

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

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Magnesium Sulfate Drug: bupevecaine Drug: saline Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Magnesium Sulfate for TAP Analgesia During Laparoscopic Cholecystectomy
Study Start Date : January 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Magnesium sulfate group
US guided TAP with magnesium sulfate
 Drug: Magnesium Sulfate
preemptive US guided TAP block will be done using Bupivacaine 0.25% plus 0.5 gm MgSo4 in M group).
Other Name: Group 1

Drug: bupevecaine
US guided TAP using Bupevecaine 0.25 %
Other Name: group 2
Experimental: B group
TAP bupevecaine
 Drug: bupevecaine
US guided TAP using Bupevecaine 0.25 %
Other Name: group 2
Placebo Comparator: C group
control TAP saline
 Drug: saline
US guided TAP using placebo (saline)
Other Name: group3


Outcome Measures
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Primary Outcome Measures :
  1. analgesia after laparoscopic cholecystectomy [ Time Frame: 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I, II for lap cholecystectomy

Exclusion Criteria:

  • ASA III, IV
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533284


Contacts
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Contact: Alrefaey Kandeel, MD 00201008158591 refa3ey2@yahioo.com

Locations
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Egypt
Mansoura university
Mansoura, Dkahleya, Egypt
Contact: Alreafey Kandeel, MD    00201008158591    refa3ey2@yahoo.com   
Sponsors and Collaborators
Mansoura University
More Information
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Responsible Party: AlRefaey Kandeel, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02533284    
Other Study ID Numbers: 5
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents