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NCT Number: NCT06367595

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

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.

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Key information

Conditions

Abdominal Hysterectomy

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

Drug

IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine

Primary outcomes

  1. 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

Secondary outcomes

  1. sedation by Ramsay sedation scale

    Time frame: Baseline

    From 1 to 6

    • Patient is anxious and agitated or restless, or both.
    • Patient is cooperative, oriented, and tranquil.
    • Patient responds to commands only.
    • Patient exhibits brisk response to light glabellar tab or loud auditory stimulus.
    • Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.
    • Patient exhibits no response.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed M Elsonbaty, Lecturer

CONTACT

[email protected]

00201011403456

Marwa S Hassanein, Res

CONTACT

[email protected]

00201159511004

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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