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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Midline Laparotomy
• Intervention / Treatment: Drug: Intrathecal Morphine; Procedure: Erector Spinae Plane Block

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University Hospital
    • Contact: Ahmed Samir Abdelmonaem, Resident doctor; Phone Number: +201022447409; Email: ahmed.abdelmonem@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intrathecal morphine alone; Drug: Intrathecal Morphine (ITM) Under sterile conditions preoperatively, a 25-gauge spinal needle is introduced at the L3-L4 or L2-L3 interspace. A 1.0 mL solution containing 100 µg of preservative-free morphine (diluted with 0.9% normal saline) is injected intrathecally upon free CSF flow. No ESPB is performed.	Drug: 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."; Other Names: Spinal Morphine; ITM
Active Comparator: Bilateral Erector Spinae Plane Block; Procedure: Bilateral Erector Spinae Plane Block Preoperatively, using a high-frequency linear ultrasound probe at the T8 vertebral level, an echogenic needle is inserted in-plane deep to the erector spinae muscle and superficial to the transverse process. After negative aspiration, 20 mL of 0.25% isobaric bupivacaine is injected. The procedure is repeated on the opposite side. No ITM is performed.	Procedure: 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.; Other Names: ESBP; Ultrasound-guided ESPB
Experimental: Intrathecal morphine + Bilateral Erector Spinae Plane Block; Combination Regimen Patients receive both interventions preoperatively. The bilateral T8 ESPB (20 mL 0.25% bupivacaine per side) is performed first in the lateral decubitus position, followed immediately by the lumbar L2-L3 or L3-L4 ITM injection (100 mcg preservative-free morphine).	Drug: 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."; Other Names: Spinal Morphine; ITM; Procedure: 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.; Other Names: ESBP; Ultrasound-guided ESPB

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Ambulation	Time taken (in hours) from the end of surgery until the patient is able to walk more than 5 meters with assistance.	Up to hospital discharge (typically up to 7 days).
Time to Readiness for PACU Discharge	Time in minutes from PACU admission until the patient achieves a modified Aldrete score \ge9.	Within the first 24 hours postoperatively.
Incidence of Adverse Events	Presence or absence (percentages) of respiratory depression (RR <8/min or SpO_2 <90% on room air), PONV requiring treatment, or pruritus requiring treatment.	Up to 48 hours postoperatively.
Patient Satisfaction with Pain Management	Score on a 5-point Likert scale ranging from 1 (Dissatisfied) to 5 (Very Satisfied).	Assessed at 48 hours postoperatively.
Quality of Recovery	Total score obtained from the 9-item Quality of Recovery (QoR-9) questionnaire.	Postoperative Day 1 (approximately 24 hours).
Healthcare Utilization	Total length of hospital stay measured in days.	From day of surgery to hospital discharge (up to 30 days).

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Beverly A, Kaye AD, Ljungqvist O, Urman RD. Essential Elements of Multimodal Analgesia in Enhanced Recovery After Surgery (ERAS) Guidelines. Anesthesiol Clin. 2017 Jun;35(2):e115-e143. doi: 10.1016/j.anclin.2017.01.018.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 19, 2026
• First Submitted That Met QC Criteria: July 19, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 19, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Intrathecal morphine; Abdominal surgery; Erector Spinae Plane Block; Opioid-sparing
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: Soh-Med-26-6-13MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared outside the research team to protect patient privacy, maintain strict data confidentiality regarding clinical interventions, and comply with institutional data management policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No