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

NCT07720739 | Recruiting

• 1 other identifier: Soh-Med-26-6-13MS
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain; Midline Laparotomy

Keywords

Erector Spinae Plane Block; Intrathecal morphine; Opioid-sparing; Abdominal surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Time to First Ambulation

  Up to hospital discharge (typically up to 7 days).

• Time to Readiness for PACU Discharge

  Within the first 24 hours postoperatively.

• Incidence of Adverse Events

  Up to 48 hours postoperatively.

• Patient Satisfaction with Pain Management

  Assessed at 48 hours postoperatively.

• Quality of Recovery

  Postoperative Day 1 (approximately 24 hours).

Study Arms (3)

Intrathecal morphine alone

ACTIVE COMPARATOR

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

Bilateral Erector Spinae Plane Block

ACTIVE COMPARATOR

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

Intrathecal morphine + Bilateral Erector Spinae Plane Block

EXPERIMENTAL

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; Procedure: Erector Spinae Plane Block

Interventions

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."

Also known as: ITM, Spinal Morphine

Intrathecal morphine + Bilateral Erector Spinae Plane Block; Intrathecal morphine alone

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.

Also known as: ESBP, Ultrasound-guided ESPB

Bilateral Erector Spinae Plane Block; Intrathecal morphine + Bilateral Erector Spinae Plane Block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 28526156 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; 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: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Surgical Intensive Care and Pain management

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)