Postoperative PainPhase 4ITM-CESAREANNCT07516717
Intrathecal Morphine 75 mcg Versus 100 mcg for Post-Cesarean Analgesia: A Randomized Double-blind Trial
A Phase 4 study testing Intrathecal Morphine in people with Postoperative Pain and Cesarean Section, run by Hospital Universitario de Caracas at 1 site in Venezuela.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Pain, Cesarean Section, Obstetric Anesthesia
- What is being tested?
- Intrathecal Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteVenezuela
- Study dates
- 7 Jan 2023to 17 Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Infection at the puncture site.
- Coagulopathy or anticoagulant therapy.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Two Doses of Intrathecal Morphine (75 mcg Versus 100mcg) for Postoperative Analgesia After Elective Cesarean Section: A Prospective, Randomized, Double-blind Controlled Trial
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.
Read the 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.
- Conditions
- Postoperative Pain, Cesarean Section, Obstetric Anesthesia
- Being tested
- Intrathecal Morphine
- Keywords
- intrathecal morphine, spinal anesthesia, cesarean delivery, postoperative analgesia, opioid side effects, visual analog scale
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineDrug
Also called Morphine sulfate
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.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Morphine 75 mcg | Experimental | Participants receive a single intrathecal dose of 75 mcg morphine during spinal anesthesia for elective cesarean delivery. Receives: Drug: Intrathecal Morphine |
| Intrathecal Morphine 100 mcg | Experimental | Participants receive a single intrathecal dose of 100 mcg morphine during spinal anesthesia for elective cesarean delivery. Receives: Drug: Intrathecal Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after cesarean delivery
Secondary outcomes (5)
Total opioid consumption within 24 horas
Total supplemental opioid requirement (e.g., tramadol or morphine equivalents) during the first 24 hours postoperatively.
Measured: 0 - 24 hours after surgery
Incidence of postoperative nausea and vomiting (PONV)
Number of patients experiencing nausea and/or vomiting requiring treatment.
Measured: 0 - 24 hours after surgery.
Incidence of pruritus
Number of patients reporting clinically significant itching requiring treatment.
Measured: 0 - 24 hours after surgery.
Time to first rescue analgesia
Time elapsed from spinal anesthesia to first request for additional analgesia.
Measured: 0 - 24 hours after surgery.
Neonatal outcome
Apgar scores assessed at 1 and 5 minutes after birth
Measured: at birth (1 and 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start7 Jan 2023
- Primary completion15 Jun 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Caracas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Alejandro Veraza Almeida, Hospital Universitario de Caracas
- Investigators
- Joseph a Veraza, Md, Principal investigator, Hospital Universitario de Caracas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516717
- Sponsor's protocol ID
- HUC-ITM-2023-01
- Acronym
- ITM-CESAREAN
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Two Doses of Intrathecal Morphine (75 mcg Versus 100mcg) for Postoperative Analgesia After Elective Cesarean Section: A Prospective, Randomized, Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07516717
- Acronym / sponsor ID
- ITM-CESAREAN / HUC-ITM-2023-01
- Conditions
- Postoperative Pain, Cesarean Section, Obstetric Anesthesia
- Keywords
- intrathecal morphine, spinal anesthesia, cesarean delivery, postoperative analgesia, opioid side effects, visual analog scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Hospital Universitario de CaracasUniversity, hospital or other
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Morphine 75 mcg | Experimental | Drug: Intrathecal MorphineParticipants receive a single intrathecal dose of 75 mcg morphine during spinal anesthesia for elective cesarean delivery. |
| Intrathecal Morphine 100 mcg | Experimental | Drug: Intrathecal MorphineParticipants receive a single intrathecal dose of 100 mcg morphine during spinal anesthesia for elective cesarean delivery. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal MorphineAlso: Morphine sulfateIntrathecal 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. | Drug | Intrathecal Morphine 100 mcg, Intrathecal Morphine 75 mcg |
Primary outcome
Postoperative pain intensity at 24 hours
Time frame: 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.
5 secondary outcomes
Total opioid consumption within 24 horas
Time frame: 0 - 24 hours after surgery
Incidence of postoperative nausea and vomiting (PONV)
Time frame: 0 - 24 hours after surgery.
Incidence of pruritus
Time frame: 0 - 24 hours after surgery.
Time to first rescue analgesia
Time frame: 0 - 24 hours after surgery.
Neonatal outcome
Time frame: at birth (1 and 5 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- PROSPECT guideline for elective caesarean sectionLink provided by the sponsor.
- Non-opioid analgesics for chronic postsurgical painLink provided by the sponsor.
- Optimal dose of intrathecal morphine for cesarean deliveryLink provided by the sponsor.
- ERAS Society recommendations for cesarean deliveryLink provided by the sponsor.
- Intrathecal morphine dose in total hip surgeryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph a Veraza, Md principal investigator
Hospital Universitario de Caracas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intrathecal Morphine in people with Postoperative Pain and Cesarean Section, run by Hospital Universitario de Caracas at 1 site in Venezuela.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity at 24 hours (time frame: 24 hours after cesarean delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.