Comparing Intrathecal Morphine With Modified Thoracoabdominal Nerve Block Through Perichondral Approach in Major Abdominal Surgery

Not Applicable

Completed

• Conditions: Opioid Use; Postoperative Pain
• Interventions: Procedure: Regional Block Comparison

• Registration Number: NCT06346860
• Lead Sponsor: Marmara University

Brief Summary

Abdominal surgery causes severe postoperative pain due to retraction of the abdominal wall and direct manipulation of visceral organs. It leads to delayed postoperative recovery, increased postoperative morbidity and mortality. Intrathecal morphine, epidural analgesia and patient-controlled intravenous analgesia are used in postoperative pain management of abdominal surgeries. Intrathecal morphine is frequently used in many centers because it provides effective pain control. However; morphine has undesirable effects such as urinary retention, postoperative nausea and vomiting, and respiratory depression. Modified thoracoabdominal nerves block through perichondrial approach is a technique defined by the modification of the thoracoabdominal nerves block through perichondrial approach, in which local anesthetics are delivered only to the underside of the perichondral surface. The primary implication of this study is to compare postoperative pain scores and opioid consumption in patients undergoing major abdominal surgery with intrathecal morphine or modified thoracoabdominal nerves block through perichondrial approach.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-03-29
• Study First Posted: 2024-04-04
• Study Start: 2024-04-15
• Status Verified: 2024-05
• Primary Completion: 2024-07-29
• Study Completion: 2024-07-29
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Patients over 18 years old
• Patients undergoing major abdominal surgery

Exclusion Criteria

• Patients with solid organ dysfunction
• Patients who receive opioid or corticosteroid medication prior to surgery
• Patients with bleeding diathesis
• Patients with psychiatric disorders
• Patients who can not be contacted after surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Thoracoabdominal Nerve BlockThrough Perichondral Approach and PCA	Regional Block Comparison	Modified Thoracoabdominal Nerve BlockThrough Perichondral Approach and Intravenous Patient Controlled Analgesia
Intrathecal Morphine and Intravenous Patient Controlled Analgesia	Regional Block Comparison	Intrathecal Morphine 200 mcg and Intravenous Patient Controlled Analgesia (1 mg/ml morphine, 1 cc bolus, 7 min. locked

Primary Outcome Measures

Name	Time	Method
Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device	48 hours	Intravenous patient-controlled analgesia (PCA) is a system of opioid delivery that consists of an infusion pump interfaced with a timing device. Intravenous morphine consumption will be recorded via PCA device, then it will be documented in mg/kg units.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain assessment with Numeric Rating Scale (NRS)	48 hours	In a Numerical Rating Scale (NRS), patients are asked to choose the number
Comparison of the frequency of treatment related complications	48 hours	Bradycardia, hypotension, sedation, respiratory depression, urinary retention, itching, need for rescue analgesics.
Participant satisfaction	48 hours	Whether the patient is very pleased/ satisfied/ unsatisfied/ complainant with the pain treatment will be recorded.

Trial Locations

Locations (1)

Marmara University School of Medicine; 🇹🇷 Istanbul, Turkey