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

Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries: A Randomized Controlled Clinical Trial.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06319859

Enrollment

Registered

2024-03-20

Start date

2024-08-03

Completion date

2025-11-25

Last updated

2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

Interventions

DRUGMorphine

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Time to first analgesic requirement	48 hours post-operatively	The time to first analgesic required by the patient will be recorded

Secondary

Measure	Time frame	Description
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'
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026