Adding Magnesium Sulfate to Bupivacaine for Ilioinguinal and Iliohypogastric Nerve Block

December 14, 2021 updated by: Abdelrady S Ibrahim, MD

Efficacy of Adding Magnesium Sulfate to Bupivacaine for Ilioinguinal and Iliohypogastric Nerve Block in Acute Postherniorrhaphy Pain

Regional block of ilioinguinal and iliohypogastric (IIIH) nerves has been applied to provide postoperative analgesia after inguinal hernia repair. Magnesium sulfate (MgSo4) blocks N-methyl-d-aspartate receptors, and that is why, it was used as an adjuvant to the local anesthetic (LA) in different anesthetic approaches. Although the prolongation in postoperative duration resulting from the addition of MgSO4 to LA was significant in some literature studies, it was insignificant in others. This study was designed to investigate the adjunctive effect of MgSo4 when added to bupivacaine for IIIH blockade on the postoperative analgesic duration as a primary outcome and on the verbal rating scale (VRS) scores, analgesic consumption, and hemodynamics as secondary outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Regional block of ilioinguinal and iliohypogastric (IIIH) nerves has been applied to provide postoperative analgesia after inguinal hernia repair. Magnesium sulfate (MgSo4) blocks N-methyl-d-aspartate receptors, and that is why, it was used as an adjuvant to the local anesthetic (LA) in different anesthetic approaches. Although the prolongation in postoperative duration resulting from the addition of MgSO4 to LA was significant in some literature studies, it was insignificant in others. This study was designed to investigate the adjunctive effect of MgSo4 when added to bupivacaine for IIIH blockade on the postoperative analgesic duration as a primary outcome and on the verbal rating scale (VRS) scores, analgesic consumption, and hemodynamics as secondary outcomes. Patients were divided into two groups of 45 patients each by means of coded envelopes according to the LA used for IIIH blockade. In the first group (control group), patients received 10 ml 0.5% isobaric bupivacaine plus 1 ml normal saline for IIIH blockade, whereas in the second group (MgSo4 group), 10 ml 0.5% isobaric bupivacaine and 1 ml of MgSo4 10% were prepared. All the patients received intrathecal 3 ml 0.5% hyperbaric bupivacaine, and then, IIIH blockade was performed under ultrasound guidance according to the group. Postoperatively, VRS scores,analgesic duration, and any complication were recorded.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Mahmoud S Elmansy

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Adult male
  • American Society of Anesthesiologists physical status I or II

Exclusion Criteria:

  • Patients with body mass index greater than or equal to 35 kg/m2
  • allergy to the study drugs
  • on chronic analgesics or drug containing magnesium

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: control group
10-ml 0.5% isobaric bupivacaine and 1ml normal saline were prepared for IIIH blockade
Other: normal saline
10-ml 0.5% isobaric bupivacaine and 1ml normal saline were prepared for IIIH blockade
Other Names:
  • Control group
ACTIVE_COMPARATOR: MgSo4 group
10 ml 0.5% isobaric bupivacaine and 1ml of MgSo4 10% (100 mg) were used.
Drug: MgSo4
10 ml 0.5% isobaric bupivacaine and 1ml of MgSo4 10% (100 mg) were used
Other Names:
  • Magnesium Sulphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative incisional pain
Time Frame: 2 hours postoperatively
Postoperative incisional pain was evaluated by VRS
2 hours postoperatively
Postoperative incisional pain
Time Frame: 4 hours postoperatively
Postoperative incisional pain was evaluated by VRS
4 hours postoperatively
Postoperative incisional pain
Time Frame: 6 hours postoperatively
Postoperative incisional pain was evaluated by VRS
6 hours postoperatively
Postoperative incisional pain
Time Frame: 12 hours postoperatively
Postoperative incisional pain was evaluated by VRS
12 hours postoperatively
Postoperative incisional pain
Time Frame: 18 hours postoperatively
Postoperative incisional pain was evaluated by VRS
18 hours postoperatively
Postoperative incisional pain
Time Frame: 24 hours postoperatively
Postoperative incisional pain was evaluated by VRS
24 hours postoperatively

Collaborators and Investigators

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

Sponsor

Abdelrady S Ibrahim, MD

Investigators

  • Principal Investigator: Mahmoud S Elmansy, faculty of medicine Mansoura 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 (ACTUAL)

August 12, 2018

Primary Completion (ACTUAL)

February 7, 2020

Study Completion (ACTUAL)

April 21, 2020

Study Registration Dates

First Submitted

December 3, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (ACTUAL)

December 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 15, 2021

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB0000871250

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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