NCT07489872

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

75
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Feb 2025

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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 Progress91%
Feb 2025Jul 2026

Study Start

First participant enrolled

February 24, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

March 18, 2026

Last Update Submit

March 25, 2026

Conditions

Keywords

intrathecal morphinerectus sheath blocklower abdominal surgerypostoperative analgesia

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 COMPARATOR

Patients 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.

Procedure: Intrathecal Morphine

Bilateral Rectus Sheath Block

ACTIVE COMPARATOR

Patients 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.

Procedure: Rectus Sheath Block

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.

Intrathecal Morphine

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.

Bilateral Rectus Sheath Block

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 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)

Location

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations