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

Comparing Postoperative Analgesic Effects of Intrathecal Morphine With Modified Thoracoabdominal Nerve Block Through Perichondral Approach in Major Abdominal Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Opioid Use
• Intervention / Treatment: Procedure: Regional Block Comparison

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Marmara University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Patients over 18 years old undergoing major abdominal surgery in Marmara University Training and Research Hospital

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Modified Thoracoabdominal Nerve BlockThrough Perichondral Approach and PCA; Modified Thoracoabdominal Nerve BlockThrough Perichondral Approach and Intravenous Patient Controlled Analgesia	Procedure: Regional Block Comparison; Comparing postoperative pain and opioid consumption in groups
Placebo Comparator: Intrathecal Morphine and Intravenous Patient Controlled Analgesia; Intrathecal Morphine 200 mcg and Intravenous Patient Controlled Analgesia (1 mg/ml morphine, 1 cc bolus, 7 min. locked	Procedure: Regional Block Comparison; Comparing postoperative pain and opioid consumption in groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device	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.	48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): July 29, 2024
• Study Completion (Actual): July 29, 2024

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: intrathecal morphine; Modified Thoracoabdominal Nerve Block Through Perichondral Approach
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: 09.2024.241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No