Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnesium sulfate.
- Who it may be relevant to
- Registry conditions: Abdominal Hysterectomy. Basic parameters: 40 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Magnesium sulfate
IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine
Primary outcome measures
- effect on postoperative pain after abdominal hysterectomy using visual analog score [Time frame: Baseline]
Secondary outcome measures (4)
- sedation by Ramsay sedation scale [Time frame: Baseline]
- time of the first opioid request [Time frame: Baseline]
- Mean arterial blood pressures (MAP) [Time frame: Baseline]
- Heart rate (HR) [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Brandsborg B. Pain following hysterectomy: epidemiological and clinical aspects. Dan Med J. 2012 Jan;59(1):B4374. PMID 22239844
- Kim TK, Yoon JR. Comparison of the neuroendocrine and inflammatory responses after laparoscopic and abdominal hysterectomy. Korean J Anesthesiol. 2010 Oct;59(4):265-9. doi: 10.4097/kjae.2010.59.4.265. Epub 2010 Oct 21. PMID 21057617
- Wu CL, Fleisher LA. Outcomes research in regional anesthesia and analgesia. Anesth Analg. 2000 Nov;91(5):1232-42. doi: 10.1097/00000539-200011000-00035. No abstract available. PMID 11049915
- Camu F, Van Aken H, Bovill JG. Postoperative analgesic effects of three demand-dose sizes of fentanyl administered by patient-controlled analgesia. Anesth Analg. 1998 Oct;87(4):890-5. doi: 10.1097/00000539-199810000-00027. PMID 9768789
- Koltka K, Uludag E, Senturk M, Yavru A, Karadeniz M, Sengul T, Ozyalcin S. Comparison of equipotent doses of ropivacaine-fentanyl and bupivacaine-fentanyl in spinal anaesthesia for lower abdominal surgery. Anaesth Intensive Care. 2009 Nov;37(6):923-8. doi: 10.1177/0310057X0903700606. PMID 20014598
- Buvanendran A, McCarthy RJ, Kroin JS, Leong W, Perry P, Tuman KJ. Intrathecal magnesium prolongs fentanyl analgesia: a prospective, randomized, controlled trial. Anesth Analg. 2002 Sep;95(3):661-6, table of contents. doi: 10.1097/00000539-200209000-00031. PMID 12198056
- De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d. PMID 23669270
- Do SH. Magnesium: a versatile drug for anesthesiologists. Korean J Anesthesiol. 2013 Jul;65(1):4-8. doi: 10.4097/kjae.2013.65.1.4. Epub 2013 Jul 19. PMID 23904932
Identifiers
NCT: NCT06367595 · Intrathecal MgSO4