Efficacy of Adding Intrathecal Morphine to Erector Spinae Plane Block for Postoperative Analgesia After Midline Laparotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intrathecal Morphine, Erector Spinae Plane Block.
- Who it may be relevant to
- Registry conditions: Postoperative Pain, Midline Laparotomy. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Adding Intrathecal Morphine to Erector Spinae Plane Block for Postoperative Analgesia After Midline Laparotomy: A Prospective Randomized Study
Overview
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.
Interventions
- 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." - 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.
Primary outcome measures
- Time to First Rescue Analgesia [Time frame: Up to 48 hours postoperatively.]
- Postoperative Pain Intensity [Time frame: At rest and during a standardized cough at 0, 2, 4, 6, 12, 24, and 48 hours postoperatively.]
- Cumulative Opioid Consumption [Time frame: Up to 48 hours postoperatively.]
Secondary outcome measures (6)
- Time to First Ambulation [Time frame: Up to hospital discharge (typically up to 7 days).]
- Time to Readiness for PACU Discharge [Time frame: Within the first 24 hours postoperatively.]
- Incidence of Adverse Events [Time frame: Up to 48 hours postoperatively.]
- Patient Satisfaction with Pain Management [Time frame: Assessed at 48 hours postoperatively.]
- Quality of Recovery [Time frame: Postoperative Day 1 (approximately 24 hours).]
- Healthcare Utilization [Time frame: From day of surgery to hospital discharge (up to 30 days).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Sohag University Hospital — Sohag
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. PMID 28526156
Identifiers
NCT: NCT07720739 · Soh-Med-26-6-13MS