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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
75
Administration of a single-shot intrathecal injection containing hyperbaric bupivacaine combined with preservative-free morphine (ITM) during spinal anesthesia prior to the surgical incision."
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.
Sohag University Hospital
Sohag, Egypt
RECRUITINGTime 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.
Time frame: Up to 48 hours postoperatively.
Postoperative Pain Intensity
Numeric Rating Scale (NRS) score ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: 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).
Time frame: Up to 48 hours postoperatively.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Assessed at 48 hours postoperatively.
Quality of Recovery
Total score obtained from the 9-item Quality of Recovery (QoR-9) questionnaire.
Time frame: Postoperative Day 1 (approximately 24 hours).
Healthcare Utilization
Total length of hospital stay measured in days.
Time frame: From day of surgery to hospital discharge (up to 30 days).
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