TAP Block With Magnesium Sulfate Added to Local Anesthetic in Abdominal Hysterectomy

October 11, 2016 updated by: Ahmad Mohammad Abd El-Rahman, Assiut University

Efficacy and Safety of Magnesium Sulfate Added to Local Anesthetic in TAP Block for Postoperative Analgesia Following Total Abdominal Hysterectomy.

Major abdominal surgeries are associated with severe abdominal pain, which can affect respiratory and cardiac functions, if insufficiently managed. This increases the incidence of post-operative morbidity.

The objective of this study was to detect the efficacy and safety of magnesium sulphate as an adjuvant to the analgesia offered by local anesthetic in ultrasound guided TAP block in patients undergoing total abdominal hysterectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • weight: 50- 85 kg.
  • ASA score: I-III
  • scheduled for total abdominal hysterectomy

Exclusion Criteria:

  • history of relevant drug allergy.
  • coagulation disorders.
  • opioid dependence.
  • sepsis.
  • psychiatric illnesses that would interfere with perception and assessment of pain.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Magnesium group
patients received ultrasound guided TAP block with 20 mL of 0.25% bupivacaine plus 2 mL magnesium sulphate 10% (200 mg), on each side of the abdominal wall.
Drug: Magnesium Sulfate
ultrasound guided TAP block with 20 mL of 0.25% bupivacaine plus 2 mL magnesium sulfate 10% (200 mg), on each side of the abdominal wall.
Placebo Comparator: control group
patients received ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.
Drug: Bupivacaine
ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total postoperative morphine consumption
Time Frame: postoperative 24 hours
total amount of rescue morphine consumption in the first 24 hours postoperatively
postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: postoperative 24 hours
postoperative pain measured by VAS score recorded in the first 24 hours postoperatively
postoperative 24 hours
first request of rescue analgesia
Time Frame: postoperative 24 hours
time to the first requirement of rescue analgesia during the first 24 hours postoperatively
postoperative 24 hours
side effects
Time Frame: postoperative 24 hours
occurrence of side effects during the first 24 hours postoperatively
postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Estimate)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 11, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 177

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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