Postoperative PainPhase 4NCT07094802
Comparison of Intrathecal Bupivacaine With and Without Morphine for Post-operative Analgesia in Parturients Undergoing Elective Cesarean Section: A Randomized Controlled Trial
A Phase 4 study testing Intrathecal morphine with bupivacaine and Hyperbaric Bupivicaine in people with Postoperative Pain and Cesarean Delivery, run by Tribhuvan University Teaching Hospital, Institute Of Medicine..
Trial summary
The goal of this clinical trial is to compare intrathecal bupivacaine with or without morphine for postoperative analgesia in patients undergoing elective cesarean section. The main questions it aims to answer are: Is intrathecal bupivacaine with morphine superior to intrathecal bupivacaine alone for postoperative… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Cesarean Delivery, Analgesia, Obstetrical
- What is being tested?
- Intrathecal morphine with bupivacaine and Hyperbaric Bupivicaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2025to 15 Aug 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parturients undergoing elective caesarean section under Spinal anesthesia
- ASA PS II, III
- > 18 years
Who cannot join
- Refusal to Participate
- Contraindications to spinal anaesthesia and adjuvants INR ≥ 1.5 Plateletes < 1,00,000/cumm Severe aortic stenosis, and/or severe mitral stenosis Infection at lumbar puncture site Known allergy to local anesthetics and opioids
- Communication barrier
- Height <150 cm
About this study
The goal of this clinical trial is to compare intrathecal bupivacaine with or without morphine for postoperative analgesia in patients undergoing elective cesarean section. The main questions it aims to answer are:
Is intrathecal bupivacaine with morphine superior to intrathecal bupivacaine alone for postoperative analgesia for parturients undergoing cesarean section? What is the duration of analgesia in the two groups? Researchers will compare drug intrathecal bupivacaine with morphine to a iintrathecal bupivacaine alone to see if intrathecal morphine has benefits for psotoperative analgesia .
Read more
Participants will:
Get intrathecal bupivacaine with Morphine or intrathecal bupivacaine alone during spinal anesthesia for cesarean section.
They will be followed up for NRS pain scores and side effects for 24 hours. Time to need of first rescue analgesic will be noted
- Being tested
- Intrathecal morphine with bupivacaine, Hyperbaric Bupivicaine
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphine with bupivacaineDrug
Also called morphine, opioids, intrathecal morphine
Participants will receive 100 mcg intrathecal morphine along with 2.2ml of 0.5% hyperbaric bupivacaine
Hyperbaric BupivicaineDrug
Also called Bupivacaine, hyperbaric bupivacaine
0.5% hyperbaric Bupivacaine 2.2 ml
| Study group | Role | What they receive |
|---|---|---|
| Morphine Group | Active comparator | This group will receive 2.2 ml of 0.5% hyperbaric bupivacaine + 100 mcg (0.1 ml of 1 mg/ml) Morphine intrathecally during spinal anesthesia Receives: Drug: Intrathecal morphine with bupivacaine |
| Bupivacaine Group | Placebo comparator | This group will receive 2.2 ml of 0.5% hyperbaric bupivacaine during spinal anesthesia Receives: Drug: Hyperbaric Bupivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to need of first rescue analgesic
time of spinal anesthesia to time of demand of first rescue analgesic
Measured: within 24 hours
NRS score
comapre NRS score at 0,1,6,12,18,24 hours between the groups
Measured: 24 hours
Secondary outcomes (1)
24 hours analgesic consumption
consumtion of total analgesic in first 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start15 Oct 2025 (estimated)
- Primary completion20 Mar 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megha Patrabansha, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094802
- Sponsor's protocol ID
- IT Morphine CS -072114
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intrathecal Bupivacaine With and Without Morphine for Post-operative Analgesia in Parturients Undergoing Elective Cesarean Section: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07094802
- Acronym / sponsor ID
- IT Morphine CS -072114
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 30 Jul 2025 (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.
The goal of this clinical trial is to compare intrathecal bupivacaine with or without morphine for postoperative analgesia in patients undergoing elective cesarean section. The main questions it aims to answer are:
Is intrathecal bupivacaine with morphine superior to intrathecal bupivacaine alone for postoperative analgesia for parturients undergoing cesarean section? What is the duration of analgesia in the two groups? Researchers will compare drug intrathecal bupivacaine with morphine to a iintrathecal bupivacaine alone to see if intrathecal morphine has benefits for psotoperative analgesia .
Participants will:
Get intrathecal bupivacaine with Morphine or intrathecal bupivacaine alone during spinal anesthesia for cesarean section.
They will be followed up for NRS pain scores and side effects for 24 hours. Time to need of first rescue analgesic will be noted
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine Group | Active comparator | Drug: Intrathecal morphine with bupivacaineThis group will receive 2.2 ml of 0.5% hyperbaric bupivacaine + 100 mcg (0.1 ml of 1 mg/ml) Morphine intrathecally during spinal anesthesia |
| Bupivacaine Group | Placebo comparator | Drug: Hyperbaric BupivicaineThis group will receive 2.2 ml of 0.5% hyperbaric bupivacaine during spinal anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parturients undergoing elective caesarean section under Spinal anesthesia
- ASA PS II, III
- > 18 years
Key exclusion criteria (4 listed)
- Refusal to Participate
- Contraindications to spinal anaesthesia and adjuvants INR ≥ 1.5 Plateletes < 1,00,000/cumm Severe aortic stenosis, and/or severe mitral stenosis Infection at lumbar puncture site Known allergy to local anesthetics and opioids
- Communication barrier
- Height <150 cm
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 morphine with bupivacaineAlso: morphine, opioids, intrathecal morphineParticipants will receive 100 mcg intrathecal morphine along with 2.2ml of 0.5% hyperbaric bupivacaine | Drug | Morphine Group |
| Hyperbaric BupivicaineAlso: Bupivacaine, hyperbaric bupivacaine0.5% hyperbaric Bupivacaine 2.2 ml | Drug | Bupivacaine Group |
Primary outcome
Time to need of first rescue analgesic
Time frame: within 24 hours
time of spinal anesthesia to time of demand of first rescue analgesic
NRS score
Time frame: 24 hours
comapre NRS score at 0,1,6,12,18,24 hours between the groups
1 secondary outcome
24 hours analgesic consumption
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intrathecal morphine with bupivacaine and Hyperbaric Bupivicaine in people with Postoperative Pain and Cesarean Delivery, run by Tribhuvan University Teaching Hospital, Institute Of Medicine..
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time to need of first rescue analgesic (time frame: within 24 hours). The study lists 2 primary outcomes in all. 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 30 Jul 2025.