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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal Morphine 75 mcg | Experimental | Participants receive a single intrathecal dose of 75 mcg morphine during spinal anesthesia for elective cesarean delivery. |
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| Intrathecal Morphine 100 mcg | Experimental | Participants receive a single intrathecal dose of 100 mcg morphine during spinal anesthesia for elective cesarean delivery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal Morphine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours after cesarean delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Total opioid consumption within 24 horas | Total supplemental opioid requirement (e.g., tramadol or morphine equivalents) during the first 24 hours postoperatively. | 0 - 24 hours after surgery |
| Incidence of postoperative nausea and vomiting (PONV) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph a Veraza, Md | Hospital Universitario de Caracas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Caracas | Caracas | Miranda | 1040 | Venezuela |
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| Label | URL |
|---|---|
| PROSPECT guideline for elective caesarean section | View source |
| Non-opioid analgesics for chronic postsurgical pain | View source |
| Optimal dose of intrathecal morphine for cesarean delivery |
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Individual participant data (IPD) sharing has not yet been determined. Data may be shared upon reasonable request after study completion, subject to institutional approval, ethical considerations, and data protection regulations.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 12, 2026 | |
| Reset | Apr 30, 2026 | |
| Release | May 4, 2026 | |
| Reset | May 28, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 12, 2026 | Apr 30, 2026 | |||
| May 4, 2026 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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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.
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Participants and outcomeassessors were blinded to group allocation. Intrathecal morphine dose were prepared in identical syringes to ensure cincealment.
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Number of patients experiencing nausea and/or vomiting requiring treatment.
| 0 - 24 hours after surgery. |
| Incidence of pruritus | Number of patients reporting clinically significant itching requiring treatment. | 0 - 24 hours after surgery. |
| Time to first rescue analgesia | Time elapsed from spinal anesthesia to first request for additional analgesia. | 0 - 24 hours after surgery. |
| Neonatal outcome | Apgar scores assessed at 1 and 5 minutes after birth | at birth (1 and 5 minutes) |
| ERAS Society recommendations for cesarean delivery | View source |
| Intrathecal morphine dose in total hip surgery | View source |
| May 28, 2026 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |