Cesarean Section, Obstetric Anesthesia, Postoperative Pain
Conditions
Keywords
intrathecal morphine, spinal anesthesia, cesarean delivery, postoperative analgesia, opioid side effects, visual analog scale
Brief summary
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.
Detailed description
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.
Interventions
DRUGIntrathecal Morphine
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.
Sponsors
Hospital Universitario de Caracas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and outcomeassessors were blinded to group allocation. Intrathecal morphine dose were prepared in identical syringes to ensure cincealment.
Intervention model description
Patients were randomly assigned to one of two parallel groups to recieve either 75 mcg or 100 mcg of intrathecal morphine as part of spinal anesthesia for elective cesarean delivery. Each participant received a single assigned intervention with no crossover betweenn groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant women scheduled for elective cesarean delivery under spinal anesthesia. * Age between 18 and 45 years. * ASA physical status II * Singleton term pregnancy. * Ability to provide written informed consent.
Exclusion criteria
* Contraindications to spinal anesthesia. * Known allergy or hypersensitivity to morphine or opioids. * Chronic opioid use or opioid dependence. * Significant systemic disease (ASA more or equal to III). * Pregnancy complications (e.g., preeclampsia, eclampsia). * Body mass index more than 40 kg/m2. * Infection at the puncture site. * Coagulopathy or anticoagulant therapy. * Refusal to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity at 24 hours | 24 hours after cesarean delivery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption within 24 horas | 0 - 24 hours after surgery | Total supplemental opioid requirement (e.g., tramadol or morphine equivalents) during the first 24 hours postoperatively. |
| Incidence of postoperative nausea and vomiting (PONV) | 0 - 24 hours after surgery. | Number of patients experiencing nausea and/or vomiting requiring treatment. |
| Incidence of pruritus | 0 - 24 hours after surgery. | Number of patients reporting clinically significant itching requiring treatment. |
| Time to first rescue analgesia | 0 - 24 hours after surgery. | Time elapsed from spinal anesthesia to first request for additional analgesia. |
| Neonatal outcome | at birth (1 and 5 minutes) | Apgar scores assessed at 1 and 5 minutes after birth |
Countries
Venezuela
Contacts
PRINCIPAL_INVESTIGATORJoseph a Veraza, Md
Hospital Universitario de Caracas
Outcome results
None listed