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

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Morphine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06319859

N-72-2024

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Group A

Active Comparator group

Description:

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

Treatment:

Drug: Morphine

Group B

Active Comparator group

Description:

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

Treatment:

Drug: Placebo