Magnesium Sulfate for TAP Analgesia During Laparoscopic Cholecystectomy

Postoperative Pain Clinical Trial

Official title:

Magnesium Sulfate for TAP Analgesia During Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02533284
• Other study ID #: 5
• Status: Unknown status
• Phase: N/A
• First received: April 6, 2015
• Last updated: August 22, 2015
• Start date: January 2016
• Est. completion date: October 2017

Study information

• Verified date: August 2015
• Source: Mansoura University
• Contact: Alrefaey Kandeel, MD
• Phone: 00201008158591
• Email: refa3ey2[@]yahioo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 90
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• ASA I, II for lap cholecystectomy

Exclusion Criteria:

• ASA III, IV

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Magnesium Sulfate
preemptive US guided TAP block will be done using Bupivacaine 0.25% plus 0.5 gm MgSo4 in M group).
• bupevecaine
US guided TAP using Bupevecaine 0.25 %
• saline
US guided TAP using placebo (saline)

Locations

Country	Name	City	State
Egypt	Mansoura university	Mansoura	Dkahleya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analgesia after laparoscopic cholecystectomy		24 hours