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

Phase 3CompletedNCT06319859

Cairo University50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain, Postoperative

Interventions

MorphineDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Kasr Alaini hospital

Cairo, Egypt

Outcomes

Primary Outcomes

Time to first analgesic requirement

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

Time frame: 48 hours post-operatively

Secondary Outcomes

Nalbuphine consumption

The amount of nalbuphine consumption as postoperative analgesia

Time frame: 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'

Time frame: 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

Time frame: 14 days post-operatively

Data from ClinicalTrials.gov

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