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

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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06367595
Enrollment
90
Registered
2024-04-16
Start date
2024-06-30
Completion date
2026-11-30
Last updated
2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Hysterectomy

Brief summary

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.

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.

Interventions

DRUGMagnesium sulfate

IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
effect on postoperative pain after abdominal hysterectomy using visual analog scoreBaselinethe 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

MeasureTime frameDescription
sedation by Ramsay sedation scaleBaselineFrom 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.
time of the first opioid requestBaselinetime of the first opioid request, concentration and the occurrence of complications (hypotension, bradycardia, itching, urinary retention.) all over 24 hours postoperatively.
Mean arterial blood pressures (MAP)Baselinemean 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.
Heart rate (HR)BaselineHeart rate (HR) will be recorded at time 0 then every 15 minutes in the first 2 hours, then at 6, 12, 24 hours postoperatively.

Contacts

Primary ContactMarwa S Hassanein, Res
marwasalah2525@gmail.com00201159511004
Backup ContactAhmed M Elsonbaty, Lecturer
elsonbatyahmed89@gmail.com00201011403456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026