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

Assiut University

Status and phase: Not yet enrolling; Phase 4

Conditions: Fentanyl; Magnesium Sulfate; Neostigmine

Treatments: Drug: fentanyl and bupivacaine; Drug: Magnesium Sulfate and Bupivacaine 0.125%; Drug: bupivacaine and Neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT06685705

MgSO4 neostigmine fentanyl

Details and patient eligibility

About

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

Full description

Effective analgesia aims to minimize patients stress response, pain intensity and distress, and side-effects of large single drug doses (typically an opioid). Numerous analgesic options exist for postoperative analgesia after abdominal surgery, including multiple classes of drugs and routes of administration e.g. parenteral, regional, neuraxial analgesia which include (epidural/intrathecal) techniques, truncal nerve blocks, and systemic drugs infusions.

Spinal anesthesia is a widely used technique in lower abdominal surgeries, offering several benefits such as allowing the patient to remain awake during the procedure, quick onset of action, high success rate, minimal drug dosage, effective sensory and motor blocks, and cost-effectiveness. However, despite these advantages, it can also cause side effects like hypotension, bradycardia, nausea, vomiting, and shivering.

Bupivacaine, is a commonly used local anesthetic, but its use can be limited by the duration of action and potential side effects. To enhance the analgesic effects and prolong the duration of bupivacaine, various adjuvants such as magnesium sulfate, neostigmine, and fentanyl are added intrathecally. Each adjuvant offers unique pharmacological properties that can influence spinal anesthesia's efficacy.

Magnesium sulfate, known for its N-methyl-D-aspartate (NMDA) receptor antagonist properties, decreases sensitivity to both central and peripheral pain stimuli by blocking calcium influx and reducing the excitability of NMDA receptors. Several studies have evaluated the role of magnesium sulfate (MgSO4) as an agent for pain control and reduction of analgesia requirement intra-and post-operatively. In some of these studies, researchers concluded that MgSO4 may reduce the need for opioid analgesic agents.

Neostigmine is a water-soluble, ionized compound that inhibits acetylcholinesterase (AChE). Its indication in FDA is to reverse the effect of non-depolarizing neuromuscular blockers after surgery. The drug is usually administered by intravenous injection, and the main route of excretion is the kidney. Neostigmine should be used with caution in patients with coronary heart disease, arrhythmia, recent acute coronary syndrome and myasthenia gravis. Neostigmine works by preventing the breakdown of the neurotransmitter acetylcholine. Recent studies suggest that this inhibition of acetylcholine degradation strengthens the descending modulation of afferent pain signals, offering a novel method for improving analgesia with minimal dose-related side effects. It enhances spinal cholinergic transmission, potentially increasing the analgesic effects without causing respiratory depression.

Fentanyl, a potent opioid, is commonly used as an adjuvant due to its strong analgesic properties, its primary clinical uses include sedation for intubated patients and managing severe pain, especially in those with renal failure, as it's predominantly metabolized by the liver . Fentanyl is also prescribed for chronic pain patients who have developed a tolerance to other opioids. Fentanyl is more lipid soluble than morphine which is more rapidly eliminated from cerebrospinal fluid. It provides dense blockade with complete intra- and postoperative analgesia without causing hemodynamic instability. It has relatively fewer side effects which are manageable and very well tolerated by the patients.

The comparative effectiveness of these adjuvants in prolonging the duration of analgesia, reducing postoperative opioid requirements, and minimizing adverse effects is crucial for improving patient outcomes.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • 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

Exclusion criteria

• • 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 3 patient groups

group 1

Experimental group

Description:

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

Treatment:

Drug: Magnesium Sulfate and Bupivacaine 0.125%

group 2

Experimental group

Description:

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

Treatment:

Drug: bupivacaine and Neostigmine

group3

Experimental group

Description:

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

Treatment:

Drug: fentanyl and bupivacaine