Magnesium Sulfate for TAP Analgesia During Laparoscopic Cholecystectomy

NCT ID: NCT02533284

Last Updated: 2015-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Magnesium sulfate group

US guided TAP with magnesium sulfate

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

preemptive US guided TAP block will be done using Bupivacaine 0.25% plus 0.5 gm MgSo4 in M group).

bupevecaine

Intervention Type DRUG

US guided TAP using Bupevecaine 0.25 %

B group

TAP bupevecaine

Group Type EXPERIMENTAL

bupevecaine

Intervention Type DRUG

US guided TAP using Bupevecaine 0.25 %

C group

control TAP saline

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

US guided TAP using placebo (saline)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Magnesium Sulfate

preemptive US guided TAP block will be done using Bupivacaine 0.25% plus 0.5 gm MgSo4 in M group).

Intervention Type DRUG

bupevecaine

US guided TAP using Bupevecaine 0.25 %

Intervention Type DRUG

saline

US guided TAP using placebo (saline)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Group 1 group 2 group3

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ASA I, II for lap cholecystectomy

Exclusion Criteria

* ASA III, IV
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

AlRefaey Kandeel

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mansoura university

Al Mansurah, Dkahleya, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alrefaey Kandeel, MD

Role: CONTACT

00201008158591

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alreafey Kandeel, MD

Role: primary

00201008158591

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.