Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy

April 12, 2024 updated by: Marwa Salah Hassanein, Assiut University
The present study aims to compare the effect of adding IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine in total abdominal hysterectomy regarding the duration of postoperative analgesia, hemodynamic stability, and complications.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Abdominal Hysterectomy (AH) is associated with an intense inflammatory response that can result in moderate to severe postoperative pain, sometimes difficult to control.

Postoperative pain can cause many complications such as restlessness, increased sympathetic activity, high blood pressure, and tachycardia. Opioids are effective analgesics; however, they produce unwanted side effects, such as respiratory depression, nausea, and vomiting. Nonopioid drugs can decrease opioid usage and dependency.

Different adjuvants have been added to local anesthetics to increase the duration of the regional anesthesia, decrease pain-relieving drugs, and delay the onset of postoperative pain.

According to numerous reports, Magnesium sulfate has analgesic effects and lowers opioid consumption in many surgeries especially abdominal surgeries.

The analgesic properties of magnesium are based on acting as a non-competitive antagonist of N-Methyl-D-Aspartate (NMDA) receptors in central nervous system and regulating the calcium influx into the cell. These properties avoid the central sensitization mechanisms due to the stimulation of peripheral nociceptive nerves In the spinal cord, magnesium sulfate decreases pain transmission by hyperpolarizing spinal interneurons via G-protein-mediated activation of potassium channels and by decreasing the release of the neurotransmitters (substance P and glutamate) from primary afferent terminals.

Adequate postoperative pain relief can enhance recovery and increase patient satisfaction.

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Contact Backup

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients between 40-65 years old
  • Patients with ASA clinical status I/II
  • Patients eligible for abdominal hysterectomy
  • Oncological surgery

Exclusion Criteria:

  • Body mass index (BMI) ≥ 40/kg / m2
  • Previous abdominal surgery (except cesarean section)
  • Severe cardiovascular, renal, and hepatic dysfunction
  • Contraindications to spinal anesthesia
  • Neuromuscular diseases
  • Inappropriate for spinal anesthesia
  • Patient refusal

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intrathecal

will include 30 patients who will receive

  • Intrathecal hyperbaric bupivacaine 0.5 % 12.5 mg in 2.5 ml plus magnesium sulfate 30 mg of 0.5 ml volume.
  • 250 ml of isotonic saline infusion over 15 minutes immediately before spinal anesthesia, then 250 ml of isotonic saline infusion over 2 hours.
Drug: Magnesium sulfate
IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine
Active Comparator: intravenous

will include 30 patients who will receive

- 30 mg/kg magnesium sulfate at a concentration of 100 mg/ml (regarding the ideal body weight) in 250 ml of isotonic saline infusion over 15 minutes immediately before spinal anesthesia (intrathecal hyperbaric bupivacaine 0.5 % 12.5 mg in 2.5 ml plus 0.5 ml of isotonic saline), and then 10 mg/kg/h magnesium sulfate in 250 ml isotonic saline infusion over 2 hours.
Drug: Magnesium sulfate
IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine
Placebo Comparator: placebo

will include 30 patients who will receive

  • intrathecal hyperbaric bupivacaine 0.5 % 12.5 mg in 2.5 ml plus 0.5 ml of isotonic saline.
  • 250 ml of isotonic saline infusion over 15 minutes immediately before spinal anesthesia then 250 ml of isotonic saline infusion over 2 hours.
Drug: Magnesium sulfate
IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect on postoperative pain after abdominal hysterectomy using visual analog score
Time Frame: Baseline
the pain intensity assessment at rest and on movement (from lying to sitting on the bed) using Visual analog score (VAS) This will measure pain intensity from 0 to 10 (goal is to be < 4) 0: no pain 3: mild pain 7: moderate pain 10: severe pain
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sedation by Ramsay sedation scale
Time Frame: Baseline

From 1 to 6

  1. Patient is anxious and agitated or restless, or both.
  2. Patient is cooperative, oriented, and tranquil.
  3. Patient responds to commands only.
  4. Patient exhibits brisk response to light glabellar tab or loud auditory stimulus.
  5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.
  6. Patient exhibits no response.
Baseline
time of the first opioid request
Time Frame: Baseline
time of the first opioid request, concentration and the occurrence of complications (hypotension, bradycardia, itching, urinary retention.) all over 24 hours postoperatively.
Baseline
Mean arterial blood pressures (MAP)
Time Frame: Baseline
mean arterial blood pressures (MAP) will be recorded at time 0 then every 15 minutes in the first 2 hours, then at 6, 12, 24 hours postoperatively.
Baseline
Heart rate (HR)
Time Frame: Baseline
Heart rate (HR) will be recorded at time 0 then every 15 minutes in the first 2 hours, then at 6, 12, 24 hours postoperatively.
Baseline

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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Intrathecal MgSO4

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

product manufactured in and exported from the U.S.

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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