Comparative Study Between Intrathecal Magnesium Sulfate, Neostigmine and Fentanyl As Adjuvant for Bubivacaine in Postoperative Analgesia in Lower Abdominal Surgeries

NCT06685705 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: MgSO4 neostigmine fentanyl
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

Lower abdominal surgeries often result in severe pain, which in turn can cause rapid and shallow breathing, retention of secretions and poor patient compliance. Justifiably, apart from the fear for the surgery outcome, patients are concerned mainly with postoperative pain. If treated inadequately, acute pain can have serious consequences for patient health mainly with postoperative complications, prolonged recovery and increased length of hospital stay. Higher levels of postoperative pain and pain distress are associated with increased morbidity, poorer functional recovery, and reduced quality of life. Aim of the study To compare the duration, quality of analgesia, and side effects between intrathecal Magnesium sulfate, neostigmine and fentanyl as adjuvant for bubivacaine as postoperative analgesia in lower abdominal surgeries

Conditions

Magnesium Sulfate; Neostigmine; Fentanyl

Keywords

lower abdominal surgeries

Outcome Measures

Primary Outcomes (1)

• first request of rescue analgesia

  The time of first request of rescue analgesia calculated from the time of spinal anesthesia.

  baseline

Secondary Outcomes (1)

• post operative VAS score

  baseline

Study Arms (3)

group 1

EXPERIMENTAL

patients will receive 15 mg of 0.5% hyperbaric bupivacaine + 50 mg Magnesium sulfate intrathecally.

Drug: Magnesium Sulfate and Bupivacaine 0.125%

group 2

EXPERIMENTAL

patients will receive 15mg of 0.5% hyperbaric bupivacaine + 50 µg Neostigmine intrathecally

Drug: bupivacaine and Neostigmine

group3

EXPERIMENTAL

patients will receive 15mg of 0.5% hyperbaric bupivacaine + 25µg of fentanyl intrathecally.

Drug: fentanyl and bupivacaine

Interventions

Magnesium Sulfate and Bupivacaine 0.125% DRUG

patients will receive 15 mg of 0.5% hyperbaric bupivacaine + 50 mg Magnesium sulfate intrathecally.

group 1

bupivacaine and Neostigmine DRUG

patients will receive 15mg of 0.5% hyperbaric bupivacaine + 50 µg Neostigmine intrathecally

group 2

fentanyl and bupivacaine DRUG

patients will receive 15mg of 0.5% hyperbaric bupivacaine + 25µg of fentanyl intrathecally.

group3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• the American Society of Anesthesiologists (ASA) classification I-II
• Age \>18 up to 55 years old
• Both sex
• Patients who will undergo lower abdominal surgeries

You may not qualify if:

• Patients' refusal.
• Patients with morbid obesity, cardiac diseases, hepatic diseases, renal diseases, diabetes mellitus with polyneuritis.
• Patients who were in risk-scoring groups American Society of Anesthesia III-IV.
• Hypertensive patients receiving therapy with adrenergic receptor antagonist, calcium channel blocker and/or angiotensin converting enzyme inhibitor.
• Patients with coagulation disorders, those receiving any anticoagulants.
• Any history of allergy to local anesthetic or other drugs used in the study, patients on examining drugs.
• Any contraindication to spinal anesthesia ( infection at puncture site and increased intracranial tension and Patients with psychiatric illness and neurologic diseases.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• Liu W, Bao S, Chen J, Li Y, Gu Y, Ye Q, Hai K. Bupivacaine-fentanyl isobaric spinal anesthesia reduces the risk of ICU admission in elderly patients undergoing lower limb orthopedic surgery. J Orthop Surg Res. 2024 Mar 1;19(1):160. doi: 10.1186/s13018-024-04618-x.

  PMID: 38429736 BACKGROUND

• Li LQ, Fang MD, Wang C, Lu HL, Wang LX, Xu HY, Zhang HZ. Comparative evaluation of epidural bupivacaine alone and bupivacaine combined with magnesium sulfate in providing postoperative analgesia: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Feb 5;20(1):39. doi: 10.1186/s12871-020-0947-8.

  PMID: 32024465 BACKGROUND

• Prabhakaraiah UN, Narayanappa AB, Gurulingaswamy S, Kempegowda K, Vijaynagar KA, Hanumantharayappa NB, Ramegowda DS. "Comparison of Nalbuphine Hydrochloride and Fentanyl as an Adjuvant to Bupivacaine for Spinal Anesthesia in Lower Abdominal Surgeries:" A Randomized, Double-blind Study. Anesth Essays Res. 2017 Oct-Dec;11(4):859-863. doi: 10.4103/aer.AER_40_17.

  PMID: 29284839 BACKGROUND

• Pandey V, Mohindra BK, Sodhi GS. Comparative evaluation of different doses of intrathecal neostigmine as an adjuvant to bupivacaine for postoperative analgesia. Anesth Essays Res. 2016 Sep-Dec;10(3):538-545. doi: 10.4103/0259-1162.180779.

  PMID: 27746548 BACKGROUND

• Si S, Zhao X, Su F, Lu H, Zhang D, Sun L, Wang F, Xu L. New advances in clinical application of neostigmine: no longer focusing solely on increasing skeletal muscle strength. Front Pharmacol. 2023 Aug 4;14:1227496. doi: 10.3389/fphar.2023.1227496. eCollection 2023.

  PMID: 37601044 BACKGROUND

• Liao Y, Li Y, Ouyang W. Effects and safety of neostigmine for postoperative recovery of gastrointestinal function: a systematic review and meta-analysis. Ann Palliat Med. 2021 Dec;10(12):12507-12518. doi: 10.21037/apm-21-3291.

  PMID: 35016456 BACKGROUND

• Hussien RM, Rabie AH. Sequential intrathecal injection of fentanyl and hyperbaric bupivacaine at different rates: does it make a difference? A randomized controlled trial. Korean J Anesthesiol. 2019 Apr;72(2):150-155. doi: 10.4097/kja.d.18.00173. Epub 2019 Jan 9.

  PMID: 30622224 BACKGROUND

• Taher-Baneh N, Ghadamie N, Sarshivi F, Sahraie R, Nasseri K. [Comparison of fentanyl and dexmedetomidine as an adjuvant to bupivacaine for unilateral spinal anesthesia in lower limb surgery: a randomized trial]. Braz J Anesthesiol. 2019 Jul-Aug;69(4):369-376. doi: 10.1016/j.bjan.2019.03.005. Epub 2019 Jul 27.

  PMID: 31362883 BACKGROUND

• Pirie K, Traer E, Finniss D, Myles PS, Riedel B. Current approaches to acute postoperative pain management after major abdominal surgery: a narrative review and future directions. Br J Anaesth. 2022 Sep;129(3):378-393. doi: 10.1016/j.bja.2022.05.029. Epub 2022 Jul 6.

  PMID: 35803751 BACKGROUND

MeSH Terms

Interventions

Magnesium Sulfate; Bupivacaine; Neostigmine; Fentanyl

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Mohsen Mohamed Mohsen Mahmoud, resident doctors

CONTACT

+101092209597; mohsen.16266366@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: patients will be randomly allocated into one of 3 study designed groups using serial number opaque closed envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Anesthesia, Intensive Care and Pain Management Department South Egypt cancer Institute

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11