NCT06319859
Completed
Phase 3
Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries: A Randomized Controlled Clinical Trial.
Overview
- Phase
- Phase 3
- Intervention
- Morphine
- Conditions
- Pain, Postoperative
- Sponsor
- Cairo University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Time to first analgesic requirement
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
AbdElKhalik Mahmoud Shaban
Lecturer of anaesthesia
Cairo University
Eligibility Criteria
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.
Arms & Interventions
Group A
patients will receive 0.1 mg morphine with 15 mg heavy bupivacaine intrathecally
Intervention: Morphine
Group B
patients will receive 15 mg heavy bupivacaine with 0.1 ml saline intrathecally
Intervention: Placebo
Outcomes
Primary Outcomes
Time to first analgesic requirement
Time Frame: 48 hours post-operatively
The time to first analgesic required by the patient will be recorded
Secondary Outcomes
- The incidence of other adverse effects(14 days post-operatively)
- Nalbuphine consumption(48 hours post-operatively)
- Postoperative pain(at 2, 4,8,12,18,24,30,36,42, and 48 hours post-operatively)
Study Sites (1)
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