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

Phase 3

Recruiting

• Conditions: Pain, Postoperative
• Interventions: Drug: Placebo; Drug: Morphine

• Registration Number: NCT06319859
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Study Start: 2024-03-17
• Study First Posted: 2024-03-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-21
• Last Update Posted: 2024-07-23
• Primary Completion: 2024-09
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Placebo	patients will receive 15 mg heavy bupivacaine with 0.1 ml saline intrathecally
Group A	Morphine	patients will receive 0.1 mg morphine with 15 mg heavy bupivacaine intrathecally

Primary Outcome Measures

Name	Time	Method
Time to first analgesic requirement	48 hours post-operatively	The time to first analgesic required by the patient will be recorded

Secondary Outcome Measures

Name	Time	Method
The incidence of other adverse effects	14 days post-operatively	The incidence of other adverse effects e.g. neurotoxicity, respiratory depression, nausea, vomiting, urine retention and pruritus will be recorded
Nalbuphine consumption	48 hours post-operatively	The amount of nalbuphine consumption as postoperative analgesia
Postoperative pain	at 2, 4,8,12,18,24,30,36,42, and 48 hours post-operatively	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'

Trial Locations

Locations (1)

Kasr Alaini hospital; 🇪🇬 Cairo, Egypt