Midline Laparotomy, Postoperative Pain
Conditions
Keywords
Erector Spinae Plane Block, Intrathecal morphine, Opioid-sparing, Abdominal surgery
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.
Interventions
DRUGIntrathecal 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."
PROCEDUREErector 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.
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Ambulation | 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. |
| Time to Readiness for PACU Discharge | Within the first 24 hours postoperatively. | Time in minutes from PACU admission until the patient achieves a modified Aldrete score \\ge9. |
| Incidence of Adverse Events | 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. |
| Patient Satisfaction with Pain Management | Assessed at 48 hours postoperatively. | Score on a 5-point Likert scale ranging from 1 (Dissatisfied) to 5 (Very Satisfied). |
| Quality of Recovery | Postoperative Day 1 (approximately 24 hours). | Total score obtained from the 9-item Quality of Recovery (QoR-9) questionnaire. |
| Healthcare Utilization | From day of surgery to hospital discharge (up to 30 days). | Total length of hospital stay measured in days. |
Countries
Egypt
Outcome results
None listed