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NCT Number: NCT06319859

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

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kasr Alaini hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Morphine

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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

  1. Nalbuphine consumption

    Time frame: 48 hours post-operatively

    The amount of nalbuphine consumption as postoperative analgesia

  2. Postoperative pain

    Time frame: 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'

  3. The incidence of other adverse effects

    Time frame: 14 days post-operatively

    The incidence of other adverse effects e.g. neurotoxicity, respiratory depression, nausea, vomiting, urine retention and pruritus will be recorded

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2024
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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