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Recruiting Not applicable

Efficacy of Adding Intrathecal Morphine to Erector Spinae Plane Block for Postoperative Analgesia After Midline Laparotomy

NCT07720739 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-07
Last updated
2026-07-22

Condition(s) studied

Postoperative PainMidline Laparotomy

Investigational drug(s) / intervention(s)

Intrathecal Morphine →Erector Spinae Plane Block

Intrathecal Morphine: Administration of a single-shot intrathecal injection containing hyperbaric bupivacaine combined with preservative-free morphine (ITM) during spinal anesthesia prior to the surgical incision."

Erector Spinae Plane Block: Bilateral ultrasound-guided erector spinae plane block performed at the T8-T10 level using a local anesthetic solution (such as bupivacaine or ropivacaine) injected deep to the erector spinae muscle fascia for postoperative abdominal analgesia.

Study summary

This study evaluates whether combining two distinct pain-relief techniques-a peripheral nerve block called the Erector Spinae Plane Block (ESPB) and a low-dose spinal medication injection called Intrathecal Morphine (ITM)-provides better postoperative pain management for adult patients undergoing major midline abdominal surgery (laparotomy) compared to using either technique alone. The main goal is to see if this combination improves pain control and reduces the total amount of opioids required by patients within the first 48 hours after surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria Patients scheduled to undergo elective or emergency midline exploratory laparotomy. American Society of Anesthesiologists (ASA) physical status I, II, or III. Intact cognitive ability to comprehend study procedures, use the Numeric Rating Scale (NRS) accurately, and provide informed consent. Exclusion Criteria Contraindications to regional or neuraxial anesthesia (e.g., patient refusal, localized infection at needle insertion sites, known coagulopathy (INR \>1.5 or platelet count \<80,000/\\mu L), or un-pausable therapeutic anticoagulation). Known allergy or severe hypersensitivity to local anesthetics or morphine. Chronic pain conditions requiring daily opioid consumption for \>3 months preoperatively. Documented history of substance use disorder. Severe chronic respiratory disease (e.g., COPD requiring home oxygen therapy, or severe obstructive sleep apnea not managed with CPAP). Neurological or psychiatric conditions that compromise sensory perception or communication. Surgical incisions planned to extend significantly past the midline. Severe spinal deformities or a history of spinal surgery at the targeted block/injection interspaces. Concurrent enrollment in any other interventional clinical trial.

Primary outcome measure(s)

  • Time to First Rescue Analgesia — Up to 48 hours postoperatively.
    Duration of time (in minutes/hours) elapsed from PACU admission to the patient's first request for an IV morphine rescue bolus.
  • Postoperative Pain Intensity — At rest and during a standardized cough at 0, 2, 4, 6, 12, 24, and 48 hours postoperatively.
    Numeric Rating Scale (NRS) score ranging from 0 (no pain) to 10 (worst imaginable pain).
  • Cumulative Opioid Consumption — Up to 48 hours postoperatively.
    Total postoperative intravenous rescue morphine consumed, calculated and recorded in Morphine Milligram Equivalents (MME).

Trial sites (1)

FacilityCityRegionStatus
Sohag University Hospital Sohag Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07720739 on ClinicalTrials.gov ↗ ← All trials in Egypt