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Clinical Trials/NCT07489872
NCT07489872Active, not recruitingNot Applicable

Efficacy of Analgesic Methods for Pain Control After Lower Abdominal Surgery With Midline Incision

Marmara University2 sites in 1 country66 target enrollmentStarted: February 24, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
66
Locations
2
Primary Endpoint
Opioid Consumption

Study Overview

Brief Summary

This study aims to evaluate the efficacy of intrathecal morphine and rectus sheath block compared with standard postoperative analgesia for pain management in patients undergoing lower abdominal surgery with a midline incision. Effective postoperative analgesia is essential to enhance recovery, reduce opioid consumption, and improve overall patient comfort.

In this prospective randomized controlled trial, eligible patients scheduled for lower abdominal surgery through a midline incision will be randomly assigned to one of three groups: intrathecal morphine, rectus sheath block, or control (standard postoperative analgesia without regional intervention). Postoperative outcomes will include pain scores, quality of recovery (QoR) scores, functional recovery parameters, patient satisfaction, incidence of postoperative nausea and vomiting, and rescue analgesic requirements.

The findings of this study may provide evidence on the comparative effectiveness of these analgesic strategies and contribute to the development of optimized multimodal pain management protocols in lower abdominal surgery.

Detailed Description

This study aims to evaluate the efficacy of intrathecal morphine and rectus sheath block compared with standard postoperative analgesia for pain management in patients undergoing lower abdominal surgery with a midline incision. Effective postoperative analgesia is essential to enhance recovery, reduce opioid consumption, and improve overall patient comfort.

In this prospective randomized controlled trial, eligible patients scheduled for lower abdominal surgery through a midline incision will be randomly assigned to one of three groups: intrathecal morphine, rectus sheath block, or control (standard postoperative analgesia without regional intervention). Postoperative outcomes will include pain scores, quality of recovery (QoR) scores, functional recovery parameters, patient satisfaction, incidence of postoperative nausea and vomiting, and rescue analgesic requirements.

The findings of this study may provide evidence on the comparative effectiveness of these analgesic strategies and contribute to the development of optimized multimodal pain management protocols in lower abdominal surgery.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients over 18 years old
  • Patients undergoing lower abdominal surgery via midline incision.

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

Outcomes

Primary Outcomes

Opioid Consumption

Time Frame: 24 hours postoperatively

The total amount of intravenous tramadol administered during the first 24 hours after surgery will be recorded to evaluate postoperative analgesic requirements.

Secondary Outcomes

  • Change in QoR-15 score(preoperative baseline and 24 hours postoperatively)
  • NRS Score(24 hours postoperatively)
  • Functional recovery(24 hours postoperatively)
  • Rescue Analgesic Consumption(24 hours postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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