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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06346860
• Other study ID #: 09.2024.241
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Marmara University
• Contact: Beliz Bilgili
• Phone: 05362187927
• Email: belizbilgili[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Regional Block Comparison
Comparing postoperative pain and opioid consumption in groups

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

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