Comparison of Intrathecal Morphine and Rectus Sheath Block for Postoperative Pain Management After Lower Abdominal Surgery With Midline Incision
Efficacy of Analgesic Methods for Pain Control After Lower Abdominal Surgery With Midline Incision
1 other identifier
interventional
66
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 24, 2025
CompletedFirst Submitted
Initial submission to the registry
March 18, 2026
CompletedFirst Posted
Study publicly available on registry
March 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
March 30, 2026
March 1, 2026
1.3 years
March 18, 2026
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Opioid Consumption
The total amount of intravenous tramadol administered during the first 24 hours after surgery will be recorded to evaluate postoperative analgesic requirements.
24 hours postoperatively
Secondary Outcomes (4)
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
Study Arms (2)
Intrathecal Morphine
ACTIVE COMPARATORPatients in this group will receive intrathecal morphine administered prior to general anesthesia as part of their perioperative analgesic regimen for postoperative pain control following lower abdominal surgery with a midline incision. Standard postoperative care will also be provided.
Bilateral Rectus Sheath Block
ACTIVE COMPARATORPatients in this group will receive a bilateral rectus sheath block administered after general anesthesia but prior to surgical incision, in addition to standard postoperative analgesia for pain management following lower abdominal surgery via midline incision.
Interventions
Patients in this group will receive 200 mcg of intrathecal morphine administered at the L3-L4 interspace prior to general anesthesia as part of their perioperative analgesic regimen for postoperative pain control following lower abdominal surgery with a midline incision. As part of standard perioperative care, all patients will receive 8 mg dexamethasone and 1.5 mg/kg intravenous tramadol. Postoperatively, all patients will have intravenous tramadol PCA (10 mg/kg). Rescue analgesia with 3 mg intravenous morphine will be administered if the numeric rating scale (NRS) pain score is 4 or higher.
Patients in this group will receive a bilateral rectus sheath block after induction of general anesthesia but prior to surgical incision, with 20 ml solution (10 ml of 0.25% bupivacaine and 10 ml of normal saline) administered to each side, in addition to standard perioperative analgesia. As part of standard care, all patients will receive 8 mg dexamethasone and 1.5 mg/kg intravenous tramadol. Postoperatively, all patients will have intravenous tramadol PCA (10 mg/kg). Rescue analgesia with 3 mg intravenous morphine will be administered if the numeric rating scale (NRS) pain score is 4 or higher.
Eligibility Criteria
You may qualify if:
- Patients over 18 years old
- Patients undergoing lower abdominal surgery via midline incision.
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 (2)
Marmara University School of Medicine, Istanbul
Istanbul, Turkey (Türkiye)
Marmara University School of Medicine
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2026
First Posted
March 24, 2026
Study Start
February 24, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
July 30, 2026
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share