NCT06346860

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2024

Completed
Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

March 29, 2024

Last Update Submit

February 4, 2026

Conditions

Opioid UsePostoperative Pain

Keywords

intrathecal morphineModified Thoracoabdominal Nerve Block Through Perichondral Approach

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Postoperative pain assessment with Numeric Rating Scale (NRS)

    48 hours

  • Comparison of the frequency of treatment related complications

    48 hours

  • Participant satisfaction

    48 hours

Study Arms (2)

Modified Thoracoabdominal Nerve BlockThrough Perichondral Approach and PCA

ACTIVE COMPARATOR

Modified Thoracoabdominal Nerve BlockThrough Perichondral Approach and Intravenous Patient Controlled Analgesia

Procedure: Regional Block Comparison

Intrathecal Morphine and Intravenous Patient Controlled Analgesia

PLACEBO COMPARATOR

Intrathecal Morphine 200 mcg and Intravenous Patient Controlled Analgesia (1 mg/ml morphine, 1 cc bolus, 7 min. locked

Procedure: Regional Block Comparison

Interventions

Regional Block ComparisonPROCEDURE

Comparing postoperative pain and opioid consumption in groups

Intrathecal Morphine and Intravenous Patient Controlled AnalgesiaModified Thoracoabdominal Nerve BlockThrough Perichondral Approach and PCA

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 29, 2024

First Posted

April 4, 2024

Study Start

April 15, 2024

Primary Completion

July 29, 2024

Study Completion

July 29, 2024

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations

TU(1)