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TAP Block in Laparoscopic Cholecystectomy.

NCT ID: NCT03612947

Last Updated: 2019-12-26

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2019-12-15

Brief Summary

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Ultrasound-guided transversus abdominis plane block is now widely used in abdominal surgery. Recently, magnesium sulphate is used as adjuvant to local anesthetics.

Detailed Description

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A significant pain experienced by patients after laparoscopic cholecystectomy surgery is required so as to block nociceptive transmission from both the abdominal wall incision, and visceral sites.

Using of opioids can result in significant adverse effects, thus delaying early mobilization of patients.

Ultrasound-guided transversus abdominis plane (TAP) block has been used as a satisfactory approach that provides postoperative analgesia. TAP block is safe; it diminishes or replaces the use of opioids; and it has a lower incidence of adverse effects.

Bupivacaine is a medication used to decrease feeling in a specific area. It is used by injecting it into the area, around a nerve that supplies the area, or into the spinal canal's epidural space. Bupivacaine is indicated for local infiltration, peripheral nerve block, sympathetic nerve block, and epidural and caudal blocks.

Magnesium is the fourth most plentiful cation in our body. It may be worthwhile to further study the role of supplemental magnesium in providing perioperative analgesia, because this is a relatively harmless molecule, is not expensive and also because the biological basis for its potential antinociceptive effect is promising.

Magnesium sulphate (MgSO4), N-methyl-D-aspartate receptor antagonist has the potential to be an ideal adjuvant in TAP block.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bupivacaine +magnesium sulphate

Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4.

Group Type ACTIVE_COMPARATOR

Bupivacaine +magnesium sulphate

Intervention Type DRUG

Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4

Bupivacaine only

Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).

Group Type PLACEBO_COMPARATOR

Bupivacaine only

Intervention Type DRUG

Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).

Interventions

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Bupivacaine +magnesium sulphate

Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4

Intervention Type DRUG

Bupivacaine only

Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients (age: 18-65 years old) undergoing laparoscopic cholecystectomy.

Exclusion Criteria

* Patient refusal
* Patients with a history of cardiac, or respiratory diseases ( \>ASA III).
* Patients with allergy to amide local anesthetics or medication included in the study.
* Infection at the needle insertion site.
* Pregnancy
* BMI \>35
* Drug abusers
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Seham Mohamed Moeen Ibrahim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine Assuit University

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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52018

Identifier Type: -

Identifier Source: org_study_id