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

NCT06367595 | Not Yet Recruiting Phase 2

• 1 other identifier: Intrathecal MgSO4
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Abdominal Hysterectomy

Outcome Measures

Primary Outcomes (1)

• effect on postoperative pain after abdominal hysterectomy using visual analog score

  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 Outcomes (4)

• sedation by Ramsay sedation scale

  Baseline

• time of the first opioid request

  Baseline

• Mean arterial blood pressures (MAP)

  Baseline

• Heart rate (HR)

  Baseline

Study Arms (3)

intrathecal

ACTIVE COMPARATOR

will include 30 patients who will receive * Intrathecal hyperbaric bupivacaine 0.5 % 20 mg in 4 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

intravenous

ACTIVE COMPARATOR

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 % 20 mg in 4 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

placebo

PLACEBO COMPARATOR

will include 30 patients who will receive * intrathecal hyperbaric bupivacaine 0.5 % 20 mg in 4 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

Interventions

Magnesium sulfate DRUG

IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine

intrathecal; intravenous; placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (15)

• Brandsborg B. Pain following hysterectomy: epidemiological and clinical aspects. Dan Med J. 2012 Jan;59(1):B4374.

  PMID: 22239844 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Ishii H, Kohno T, Yamakura T, Ikoma M, Baba H. Action of dexmedetomidine on the substantia gelatinosa neurons of the rat spinal cord. Eur J Neurosci. 2008 Jun;27(12):3182-90. doi: 10.1111/j.1460-9568.2008.06260.x. Epub 2008 Jun 1.

  PMID: 18554299 BACKGROUND

• Shang AB, Gan TJ. Optimising postoperative pain management in the ambulatory patient. Drugs. 2003;63(9):855-67. doi: 10.2165/00003495-200363090-00002.

  PMID: 12678572 BACKGROUND

• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

  PMID: 30211382 BACKGROUND

• Khan BA, Guzman O, Campbell NL, Walroth T, Tricker JL, Hui SL, Perkins A, Zawahiri M, Buckley JD, Farber MO, Ely EW, Boustani MA. Comparison and agreement between the Richmond Agitation-Sedation Scale and the Riker Sedation-Agitation Scale in evaluating patients' eligibility for delirium assessment in the ICU. Chest. 2012 Jul;142(1):48-54. doi: 10.1378/chest.11-2100.

  PMID: 22539644 BACKGROUND

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

• Yazdi AP, Esmaeeli M, Gilani MT. Effect of intravenous magnesium on postoperative pain control for major abdominal surgery: a randomized double-blinded study. Anesth Pain Med (Seoul). 2022 Jul;17(3):280-285. doi: 10.17085/apm.22156. Epub 2022 Jul 28.

  PMID: 35918860 BACKGROUND

• Benevides ML, Fialho DC, Linck D, Oliveira AL, Ramalho DHV, Benevides MM. Intravenous magnesium sulfate for postoperative analgesia after abdominal hysterectomy under spinal anesthesia: a randomized, double-blind trial. Braz J Anesthesiol. 2021 Sep-Oct;71(5):498-504. doi: 10.1016/j.bjane.2021.01.008. Epub 2021 Mar 21.

  PMID: 33762190 BACKGROUND

MeSH Terms

Interventions

Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Hamdy A Youssef, Professor

  Assuit University Hospital

  STUDY CHAIR

• Mohamed F Mostafa, Ass professor

  Assuit University Hospital

  STUDY CHAIR

• Ahmed M Elsonbaty, Lecturer

  Assuit University Hospital

  STUDY DIRECTOR

• Marwa S Hassanein, Resident

  Assuit University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa S Hassanein, Res

CONTACT

00201159511004; marwasalah2525@gmail.com

Ahmed M Elsonbaty, Lecturer

CONTACT

00201011403456; elsonbatyahmed89@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: April 16, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share