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

NCT ID: NCT06319859

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-03

Study Completion Date

2025-11-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

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

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

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

Group B

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

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Morphine

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

AbdElKhalik Mahmoud Shaban

Lecturer of anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kasr Alaini hospital

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N-72-2024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Spinal Analgesia in Labour Pain
NCT07332130 NOT_YET_RECRUITING PHASE1