- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07489872
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
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Marmara University School of Medicine
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Istanbul, Turkey (Türkiye)
- Marmara University School of Medicine, Istanbul
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Intrathecal Morphine
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.
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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.
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Active Comparator: Bilateral Rectus Sheath Block
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Opioid Consumption
Time Frame: 24 hours postoperatively
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The total amount of intravenous tramadol administered during the first 24 hours after surgery will be recorded to evaluate postoperative analgesic requirements.
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24 hours postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NRS Score
Time Frame: 24 hours postoperatively
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Postoperative pain will be assessed using the Numeric Rating Scale (NRS: 0= no pain to 10= worst pain) at 24 hours after surgery.
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24 hours postoperatively
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Functional recovery
Time Frame: 24 hours postoperatively
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Functional recovery will be assessed by recording the time to first mobilization, time to first oral intake, and time to return of bowel function within the first 24 hours after surgery.
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24 hours postoperatively
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Rescue Analgesic Consumption
Time Frame: 24 hours postoperatively
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Total amount of rescue analgesics (intravenous morphine) administered within the first 24 hours postoperatively will be recorded.
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24 hours postoperatively
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Change in QoR-15 score
Time Frame: preoperative baseline and 24 hours postoperatively
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Quality of recovery (QoR) will be assessed using the validated QoR-15 questionnaire both preoperatively and at 24 hours after surgery.
The primary analysis will evaluate the change in score from baseline to 24 hours.
The total score ranges from 0 (very poor recovery) to 150 (excellent recovery).
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preoperative baseline and 24 hours postoperatively
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2025.174
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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