Intra-operative Magnesium Sulphate for Post-operative Pain in Patients Undergoing Total Abdominal Hysterectomy Under General Anesthesia

NCT06026527 | Completed Phase 3 DMC

• 1 other identifier: MagSulf1234
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Post-operative pain management is a complex entity. It is one of the most critical parameters in the enhanced recovery after surgery protocol. Adequate postoperative pain relief leads to earlier mobilisation, shortened hospital stay, reduced hospital costs and increased patient satisfaction. For post-operative analgesia, opioids have long been the mainstay of drugs used; however, they produce unwanted side effects, such as respiratory depression, nausea, vomiting and dependence. The major goal in postoperative pain management is to minimise the dose of a single medication and lessen its side effects, while still providing adequate analgesia by the use of multimodal analgesia. Paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), regional techniques like epidural analgesia, different kind of blocks and local wound infiltration are some of the components of multimodal approach to post- operative analgesia. Besides, there are some drugs that may be used as adjuvants to opioids to enhance the analgesic efficacy and facilitate opioid sparing with a reduction in opioid related side effects. Magnesium sulphate, due to its N- Methyl D- Aspartate (NMDA) blocking property, has been studied as one of such non opioid adjuvants. The outcome of many of these studies is in favour of magnesium sulphate but there are negative reports as well. So, in this study the investigators aim to evaluate the efficacy of intra-operative intravenous magnesium sulphate for post-operative pain and opioid use in patients undergoing abdominal hysterectomy under general anaesthesia.

Conditions

Post-operative Pain

Keywords

Magnesium, Pain, NRS, Abdominal hysterectomy, MgSO4

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of magnesium sulphate for post-operative pain

  Post operative pain will be assessed by using Numerical rating score (NRS) of pain. The NRS is a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  At 0, 1, 6,12 18 and 24 hours post-operatively

Secondary Outcomes (4)

• Comparison of Numerical Rating Scale (NRS) score of pain

  at 0, 1, 6, 12, 18, 24 hours post-operatively

• Opioid as rescue analgesic use

  The time to first rescue analgesic use within 24 hours post-operatively will be noted

• Total opioid use

  within 24 hours post-operatively

• Side effects

  within 24 hours post-operatively

Study Arms (2)

Group M

EXPERIMENTAL

Magnesium group

Drug: Magnesium sulfate

Group C

PLACEBO COMPARATOR

Control group

Drug: Normal Saline

Interventions

Magnesium sulfate DRUG

50 mg/kg Magnesium sulphate in 93-95 ml Normal Saline ( making a total of 100 ml solution )will be infused intravenously over 20-30 minutes in the participants allocated to M group starting from the moment of induction of anaesthesia

Also known as: Magnesium sulphate

Group M

Normal Saline DRUG

100 ml Normal Saline will be infused intravenously over 20-30 minutes in the participants allocated to control group starting from the moment of induction of anaesthesia

Also known as: NS

Group C

Eligibility Criteria

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

You may qualify if:

• Patient undergoing elective abdominal hysterectomy.
• Between the ages of 18- 65.
• American Society of Anesthesiologists Physical Status (ASA PS) I and II.

You may not qualify if:

• Neurological and psychiatric disorder.
• Drug or alcohol abuse.
• Patients with a known or suspected allergy to magnesium sulphate.
• Patients with any contraindication to magnesium sulphate (heart blocks, neuromuscular diseases)

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead

Study Sites (1)

Tribhuvan University Teaching Hospital

Kathmandu, Bagmati, 44600, Nepal

Location

Related Publications (21)

• Shekhar C, Paswan B, Singh A. Prevalence, sociodemographic determinants and self-reported reasons for hysterectomy in India. Reprod Health. 2019 Aug 2;16(1):118. doi: 10.1186/s12978-019-0780-z.

  PMID: 31375139 BACKGROUND

• Clarke-Pearson DL, Geller EJ. Complications of hysterectomy. Obstet Gynecol. 2013 Mar;121(3):654-673. doi: 10.1097/AOG.0b013e3182841594.

  PMID: 23635631 BACKGROUND

• Perniola A, Gupta A, Crafoord K, Darvish B, Magnuson A, Axelsson K. Intraabdominal local anaesthetics for postoperative pain relief following abdominal hysterectomy: a randomized, double-blind, dose-finding study. Eur J Anaesthesiol. 2009 May;26(5):421-9. doi: 10.1097/EJA.0b013e3283261b53.

  PMID: 19521298 BACKGROUND

• Chung F, Ritchie E, Su J. Postoperative pain in ambulatory surgery. Anesth Analg. 1997 Oct;85(4):808-16. doi: 10.1097/00000539-199710000-00017.

  PMID: 9322460 BACKGROUND

• Kehlet H, Dahl JB. The value of "multimodal" or "balanced analgesia" in postoperative pain treatment. Anesth Analg. 1993 Nov;77(5):1048-56. doi: 10.1213/00000539-199311000-00030. No abstract available.

  PMID: 8105724 BACKGROUND

• White PF. The role of non-opioid analgesic techniques in the management of pain after ambulatory surgery. Anesth Analg. 2002 Mar;94(3):577-85. doi: 10.1097/00000539-200203000-00019. No abstract available.

  PMID: 11867379 BACKGROUND

• Woolf CJ, Thompson SWN. The induction and maintenance of central sensitization is dependent on N-methyl-D-aspartic acid receptor activation; implications for the treatment of post-injury pain hypersensitivity states. Pain. 1991 Mar;44(3):293-299. doi: 10.1016/0304-3959(91)90100-C.

  PMID: 1828878 BACKGROUND

• Latremoliere A, Woolf CJ. Central sensitization: a generator of pain hypersensitivity by central neural plasticity. J Pain. 2009 Sep;10(9):895-926. doi: 10.1016/j.jpain.2009.06.012.

  PMID: 19712899 BACKGROUND

• Woolf CJ, Salter MW. Neuronal plasticity: increasing the gain in pain. Science. 2000 Jun 9;288(5472):1765-9. doi: 10.1126/science.288.5472.1765.

  PMID: 10846153 BACKGROUND

• Tramer MR, Schneider J, Marti RA, Rifat K. Role of magnesium sulfate in postoperative analgesia. Anesthesiology. 1996 Feb;84(2):340-7. doi: 10.1097/00000542-199602000-00011.

  PMID: 8602664 BACKGROUND

• Wilder-Smith CH, Knopfli R, Wilder-Smith OH. Perioperative magnesium infusion and postoperative pain. Acta Anaesthesiol Scand. 1997 Sep;41(8):1023-7. doi: 10.1111/j.1399-6576.1997.tb04830.x.

  PMID: 9311401 BACKGROUND

• Ko SH, Lim HR, Kim DC, Han YJ, Choe H, Song HS. Magnesium sulfate does not reduce postoperative analgesic requirements. Anesthesiology. 2001 Sep;95(3):640-6. doi: 10.1097/00000542-200109000-00016.

  PMID: 11575536 BACKGROUND

• Kara H, Sahin N, Ulusan V, Aydogdu T. Magnesium infusion reduces perioperative pain. Eur J Anaesthesiol. 2002 Jan;19(1):52-6. doi: 10.1017/s026502150200008x.

  PMID: 11913804 BACKGROUND

• Feld JM, Laurito CE, Beckerman M, Vincent J, Hoffman WE. Non-opioid analgesia improves pain relief and decreases sedation after gastric bypass surgery. Can J Anaesth. 2003 Apr;50(4):336-41. doi: 10.1007/BF03021029. English, French.

  PMID: 12670809 BACKGROUND

• Taheri A, Haryalchi K, Mansour Ghanaie M, Habibi Arejan N. Effect of low-dose (single-dose) magnesium sulfate on postoperative analgesia in hysterectomy patients receiving balanced general anesthesia. Anesthesiol Res Pract. 2015;2015:306145. doi: 10.1155/2015/306145. Epub 2015 Feb 1.

  PMID: 25705223 BACKGROUND

• Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.

  PMID: 18487245 BACKGROUND

• Hammond DA, Stojakovic J, Kathe N, Tran J, Clem OA, Erbach K, King J. Effectiveness and Safety of Magnesium Replacement in Critically Ill Patients Admitted to the Medical Intensive Care Unit in an Academic Medical Center: A Retrospective, Cohort Study. J Intensive Care Med. 2019 Nov-Dec;34(11-12):967-972. doi: 10.1177/0885066617720631. Epub 2017 Jul 13.

  PMID: 28703019 BACKGROUND

• Yamaguchi H, Shimada H, Yoshita K, Tsubata Y, Ikarashi K, Morioka T, Saito N, Sakai S, Narita I. Severe hypermagnesemia induced by magnesium oxide ingestion: a case series. CEN Case Rep. 2019 Feb;8(1):31-37. doi: 10.1007/s13730-018-0359-5. Epub 2018 Aug 22.

  PMID: 30136128 BACKGROUND

• Kobelt P, Burke K, Renker P. Evaluation of a standardized sedation assessment for opioid administration in the post anesthesia care unit. Pain Manag Nurs. 2014 Sep;15(3):672-81. doi: 10.1016/j.pmn.2013.11.002. Epub 2014 Jan 22.

  PMID: 24461253 BACKGROUND

• BELLVILLE JW, BROSS ID, HOWLAND WS. A method for the clinical evaluation of antiemetic agents. Anesthesiology. 1959 Nov-Dec;20:753-60. doi: 10.1097/00000542-195911000-00002. No abstract available.

  PMID: 13798617 BACKGROUND

• Blaine J, Chonchol M, Levi M. Renal control of calcium, phosphate, and magnesium homeostasis. Clin J Am Soc Nephrol. 2015 Jul 7;10(7):1257-72. doi: 10.2215/CJN.09750913. Epub 2014 Oct 6.

  PMID: 25287933 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Magnesium Sulfate; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Subhash P Acharya, MD FACC FCCP

  Tribhuvan University Teaching Hospital

  STUDY CHAIR

• Bashu D Parajuli, MD, FOA

  Tribhuvan University Teaching Hospital

  STUDY CHAIR

• Pankaj Joshi, MD, FLTA (ICA)

  Tribhuvan University Teaching Hospital

  STUDY CHAIR

• Priyanka Dahal, MD Resident

  Tribhuvan University Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Resident- Anaesthesiology

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 7, 2023
• Study Start: March 3, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 30, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)