Intrathecal Morphine or Fentanyl for Spine Surgery

Phase 3

Recruiting

• Conditions: Spinal Diseases.; Disease of spinal cord, unspecified; G95.9

• Registration Number: IRCT20230717058820N1
• Lead Sponsor: Kerman University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Age between 18 to 85
American Society of Anesthesia (ASA) classification I or II
Candidates for surgeries of spine
Informed consent to enter the study

Exclusion Criteria

Pregnancy or breastfeeding at the time of enrollment
History of allergy to local anesthetic agents
History of cardiac or renal failure
Opioid use disorder
Uncontrolled blood pressure
Body mass index above 40 kg/m2
Preoperative heart rate less than 50 beats/min
Spinal cord injuries that could interfere with the pain assessment
Incidental intraoperative durotomy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain intensity. Timepoint: 4, 6, 12, 18 hours post-operation. Method of measurement: Visual Analogue Scale.

Secondary Outcome Measures

Name	Time	Method
Time interval from the surgical procedure until the patient required supplementary analgesics. Timepoint: From the operation till maximum 18 hours. Method of measurement: Timer.;Side effects (Postoperative nausea/vomiting, pruritus, dyspnea, respiratory depression). Timepoint: From the operation till maximum 18 hours. Method of measurement: Subjective assessment.