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NCT Number: NCT07720739

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

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.

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Key information

Conditions

Postoperative Pain Midline Laparotomy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University Hospital

Sohag, Egypt

Location status: Recruiting

Location contact

Ahmed Samir Abdelmonaem, Resident doctor

CONTACT

[email protected]

+201022447409

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intrathecal morphine

Drug

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

Other names: ITM, Spinal Morphine

Erector Spinae Plane Block

Procedure

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.

Other names: ESBP, Ultrasound-guided ESPB

Primary outcomes

  1. Time to First Rescue Analgesia

    Time frame: 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.

  2. Postoperative Pain Intensity

    Time frame: 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).

  3. Cumulative Opioid Consumption

    Time frame: Up to 48 hours postoperatively.

    Total postoperative intravenous rescue morphine consumed, calculated and recorded in Morphine Milligram Equivalents (MME).

Secondary outcomes

  1. Time to First Ambulation

    Time frame: Up to hospital discharge (typically up to 7 days).

    Time taken (in hours) from the end of surgery until the patient is able to walk more than 5 meters with assistance.

  2. Time to Readiness for PACU Discharge

    Time frame: Within the first 24 hours postoperatively.

    Time in minutes from PACU admission until the patient achieves a modified Aldrete score \\ge9.

  3. Incidence of Adverse Events

    Time frame: Up to 48 hours postoperatively.

    Presence or absence (percentages) of respiratory depression (RR <8/min or SpO_2 <90% on room air), PONV requiring treatment, or pruritus requiring treatment.

  4. Patient Satisfaction with Pain Management

    Time frame: Assessed at 48 hours postoperatively.

    Score on a 5-point Likert scale ranging from 1 (Dissatisfied) to 5 (Very Satisfied).

  5. Quality of Recovery

    Time frame: Postoperative Day 1 (approximately 24 hours).

    Total score obtained from the 9-item Quality of Recovery (QoR-9) questionnaire.

  6. Healthcare Utilization

    Time frame: From day of surgery to hospital discharge (up to 30 days).

    Total length of hospital stay measured in days.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Efficacy of Adding Intrathecal Morphine to Erector Spinae Plane Block for Postoperative Analgesia After Midline Laparotomy: A Prospective Randomized Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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