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

Pain, Postoperative Clinical Trial

Official 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06319859
• Other study ID #: N-72-2024
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 2024
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia, Inguinal
• Pain, Postoperative

Intervention

Drug:
• Morphine
The patients will receive 0.1 mg morphine with 15 mg heavy bupivacaine intrathecally
• Placebo
The patients will receive 15 mg heavy bupivacaine with 0.1 ml saline intrathecally

Locations

Country	Name	City	State
Egypt	Kasr Alaini hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first analgesic requirement	The time to first analgesic required by the patient will be recorded	48 hours post-operatively
Secondary	Nalbuphine consumption	The amount of nalbuphine consumption as postoperative analgesia	48 hours post-operatively
Secondary	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'	at 2, 4,8,12,18,24,30,36,42, and 48 hours post-operatively
Secondary	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	14 days post-operatively