Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries

Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries: A Randomized Controlled Clinical Trial.

This study will evaluate the efficacy and safety of intrathecal non-preservative-free morphine and its effect on pain in patients undergoing unilateral inguinal hernia surgeries.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Morphine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr Alaini Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18-65 years old.
• Both genders.
• ASA I and II class.

Exclusion Criteria:

• Patient refusal.
• Known local anesthetic (LA) allergy.
• Skin lesions or infections at the site of needle insertion.
• Contraindications to spinal anesthesia.
• Failure of spinal anesthesia.
• ASA III and VI class.
• Central or peripheral neuropathies.
• Severe respiratory or cardiac diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; patients will receive 0.1 mg morphine with 15 mg heavy bupivacaine intrathecally	Drug: Morphine; The patients will receive 0.1 mg morphine with 15 mg heavy bupivacaine intrathecally
Active Comparator: Group B; patients will receive 15 mg heavy bupivacaine with 0.1 ml saline intrathecally	Drug: Placebo; The patients will receive 15 mg heavy bupivacaine with 0.1 ml saline intrathecally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first analgesic requirement	The time to first analgesic required by the patient will be recorded	48 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nalbuphine consumption	The amount of nalbuphine consumption as postoperative analgesia	48 hours post-operatively
Postoperative pain	Postoperative pain at rest and movement by numeric rating scale Patients will be asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'	at 2, 4,8,12,18,24,30,36,42, and 48 hours post-operatively
The incidence of other adverse effects	The incidence of other adverse effects e.g. neurotoxicity, respiratory depression, nausea, vomiting, urine retention and pruritus will be recorded	14 days post-operatively

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Pain, Postoperative; Hernia, Inguinal; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: N-72-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No