This study evaluates the efficacy and safety of two different doses of intrathecal morphine (75 mcg versus 100 mcg) for postoperative analgesia in patients undergoing elective cesarean delivery under spinal anesthesia. Effective postoperative pain control is essential to improve maternal recovery, facilitate early mobilization, and enhance neonatal care. Participants were randomly of assigned to receive either 75 mcg or 100 mcg of intrathecal morphine dose that provides effective analgesia while minimizing adverse effects in the obstetric population.
This prospective, randomized, double-blind controlled trial was designed to compare the analgesic efficacy and safety of two doses of intrathecal morphine (75 mcg versus 100 mcg) in patients undergoing elective cesarean delivery under spinal anesthesia. A total of 240 ASA physical status II patients schedule for elective cesarean delivery were enrolled and randomly assigned into two parallel groups. Patients received either 75 mcg or 100 mcg of intrathecal morphine as part of a standardized spinal anesthesia technique using local anesthetic. Randomization was performed using a predefined allocation method, and both patients and outcome assessors were blinded to group assignment. Perioperative management was standardized across both groups to minimize confounding variables. Postoperative pain intensity was assessed using the Visual Analog Scale (VAS) at 2, 4, 8, 12 and 24 hours following surgery. The primary outcome was VAS pain score at 24 hours. Secondary outcomes included pain scores at earlier time points, requirement for rescue analgesia, incidence of opioid-related adverse effects (nausea, vomiting, pruritus), and neonatal outcomes assessed by Apgar scores. The objetive of this study was to determinethe optimal intrathecal morphine dose that provides effective postoperative analgesia while minimizing adverse effects in the obstetric population. The study was conducted in accordance with institutional ethical standards and approved by the corresponding ethics committee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
Intrathecal administration of preservative-free morphine sulfate at doses of 75 mcg or 100 mcg as part of spinal anesthesia for elective cesarean delivery. The drug is administered once at the time the spinal anesthesia to provide postoperative analgesia.
Hospital Universitario de Caracas
Caracas, Miranda, Venezuela
Postoperative pain intensity at 24 hours
Pain intensity will be assessed using the Visual Analog Scale (VAS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain. Measurements will be recorded at 2, 4, 8, 12 and 24 hours after surgery. The primary endpoint is the VAS score at 24 hours.
Time frame: 24 hours after cesarean delivery
Total opioid consumption within 24 horas
Total supplemental opioid requirement (e.g., tramadol or morphine equivalents) during the first 24 hours postoperatively.
Time frame: 0 - 24 hours after surgery
Incidence of postoperative nausea and vomiting (PONV)
Number of patients experiencing nausea and/or vomiting requiring treatment.
Time frame: 0 - 24 hours after surgery.
Incidence of pruritus
Number of patients reporting clinically significant itching requiring treatment.
Time frame: 0 - 24 hours after surgery.
Time to first rescue analgesia
Time elapsed from spinal anesthesia to first request for additional analgesia.
Time frame: 0 - 24 hours after surgery.
Neonatal outcome
Apgar scores assessed at 1 and 5 minutes after birth
Time frame: at birth (1 and 5 minutes)
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