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

NCT06319859 | Completed Phase 3

• 1 other identifier: N-72-2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Time to first analgesic requirement

  The time to first analgesic required by the patient will be recorded

  48 hours post-operatively

Secondary Outcomes (3)

• Nalbuphine consumption

  48 hours post-operatively

• Postoperative pain

  at 2, 4,8,12,18,24,30,36,42, and 48 hours post-operatively

• The incidence of other adverse effects

  14 days post-operatively

Study Arms (2)

Group A

ACTIVE COMPARATOR

patients will receive 0.1 mg morphine with 15 mg heavy bupivacaine intrathecally

Drug: Morphine

Group B

ACTIVE COMPARATOR

patients will receive 15 mg heavy bupivacaine with 0.1 ml saline intrathecally

Drug: Placebo

Interventions

Morphine DRUG

The patients will receive 0.1 mg morphine with 15 mg heavy bupivacaine intrathecally

Group A

Placebo DRUG

The patients will receive 15 mg heavy bupivacaine with 0.1 ml saline intrathecally

Group B

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alaini hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anaesthesia

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: August 3, 2024
• Primary Completion: October 15, 2025
• Study Completion: November 25, 2025
• Last Updated: December 5, 2025

Record last verified: 2024-07

Locations

EG (1)