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

Abdominal Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06367595
• Other study ID #: Intrathecal MgSO4
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: November 2026

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: Marwa S Hassanein, Res
• Phone: 00201159511004
• Email: marwasalah2525[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: November 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Hysterectomy
• Pain, Postoperative

Intervention

Drug:
• Magnesium sulfate
IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (15)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	sedation by Ramsay sedation scale	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.	Baseline
Secondary	time of the first opioid request	time of the first opioid request, concentration and the occurrence of complications (hypotension, bradycardia, itching, urinary retention.) all over 24 hours postoperatively.	Baseline
Secondary	Mean arterial blood pressures (MAP)	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
Secondary	Heart rate (HR)	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