Post Cesarean Section PainPhase 4AnalgesiaNCT07560501
Optimal Intrathecal Morphine Dose for Better Post Cesarean Section Analgesia
A Phase 4 study testing 0.5% bupivacaine heavy with fentanyl, 0.5% bupivacaine heavy with fentanyl plus morphine 50 mcg and 0.5% bupivacaine heavy with fentanyl plus morphine100 mcg in people with Post Cesarean Section Pain, run by Tribhuvan University Teaching Hospital, Institute Of Medicine..
Trial summary
Central neuraxial blocks (CNBs) remain the preferred anesthetic technique for cesarean section, with single shot spinal anesthesia (SSSA) being the standard practice at investigator's institute unless contraindicated. SSSA offers reliable intraoperative anesthesia and provides a few hours of postoperative analgesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post Cesarean Section Pain
- What is being tested?
- 0.5% bupivacaine heavy with fentanyl, 0.5% bupivacaine heavy with fentanyl plus morphine 50 mcg and 0.5% bupivacaine heavy with fentanyl plus morphine100 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 28 Dec 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant lady > 36 weeks of gestation presenting for cesarean section under spinal anesthesia
- ASA II/ III
- Maternal Height > 150 cm
- BMI< 40 Kg/m2
- Elective Indication
Who cannot join
- Patient unwilling to take part in the study
- Patient with known allergy to the study medications
- Contraindication to Spinal Anesthesia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Postoperative Analgesia With Different Doses of Intrathecal Morphine With Hyperbaric Bupivacaine and Fentanyl in Cesarean Section Patients: A Randomized Controlled Trial
Central neuraxial blocks (CNBs) remain the preferred anesthetic technique for cesarean section, with single shot spinal anesthesia (SSSA) being the standard practice at investigator's institute unless contraindicated. SSSA offers reliable intraoperative anesthesia and provides a few hours of postoperative analgesia. Enhanced recovery after cesarean section protocol has recommended the addition of intrathecal (IT) morphine to improve the postoperative quality of the recovery profile. Fentanyl improves the quality of intraoperative analgesia, while morphine significantly prolongs the postoperative pain relief, often lasting up to 24 hours.
Routine uterine exteriorization, practiced in all cases at investigator's institute, often results in peritoneal stretching pain during surgery. This visceral pain is managed with 10 mcg intrathecal fentanyl added to hyperbaric bupivacaine. For postoperative pain management, the intrathecal morphine is recommended by many guidelines and studies. Intrathecal morphine dose typically ranges from 50 to 300 mcg. The dose of morphine exceeding 150 mcg are usually associated with prolongation of analgesia with higher incidence of side effects like nausea, vomiting and pruritus. In selected cases, investigator had administered morphine 100-150 mcg and the clinical experience has shown reduced postoperative analgesic requirements and favorable recovery profile, with minimal adverse effects.
Despite these promising experiences and extensive literature on IT morphine, their is still lack formal data on the efficacy and safety profile of IT morphine in cesarean section patient. This comparative study will help institute to find the optimum dose of IT morphine with better postoperative analgesia quality with low side effects profile. The finding could serve as a foundation to promote routine use of intrathecal morphine in cesarean section anesthesia at investigator's institute.
- Conditions
- Post Cesarean Section Pain
- Being tested
- 0.5% bupivacaine heavy with fentanyl, 0.5% bupivacaine heavy with fentanyl plus morphine 50 mcg, 0.5% bupivacaine heavy with fentanyl plus morphine100 mcg, 0.5% bupivacaine heavy with fentanyl plus morphine 150mcg
- Keywords
- Analgesia, Cesarean section, Intrathecal Morphine, Postoperative pain
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% bupivacaine heavy with fentanylDrug
Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile.
0.5% bupivacaine heavy with fentanyl plus morphine 50 mcgDrug
Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl with morphine 50mcg at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile.
0.5% bupivacaine heavy with fentanyl plus morphine100 mcgDrug
Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl with morphine 100mcg at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile.
0.5% bupivacaine heavy with fentanyl plus morphine 150mcgDrug
Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl with morphine 150mcg at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile.
| Study group | Role | What they receive |
|---|---|---|
| Group BF | Active comparator | Intrathecal drug used: 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml), total volume of 2.2ml, single administration, no repetition of intervention In this group, no dose of morphine will be added. Receives: Drug: 0.5% bupivacaine heavy with fentanyl |
| Group BF-M50 | Experimental | Intrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml) plus morphine 50mcg (0.05ml) with total volume of 2.25ml single administration, no repetition of intervention Receives: Drug: 0.5% bupivacaine heavy with fentanyl plus morphine 50 mcg |
| Group BF-M100 | Experimental | Intrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml) plus morphine 100mcg (0.1ml) with total volume of 2.3ml single administration, no repetition of intervention Receives: Drug: 0.5% bupivacaine heavy with fentanyl plus morphine100 mcg |
| Group BF-M150 | Experimental | Intrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml) plus morphine 150mcg (0.15ml) with total volume of 2.35ml single administration, no repetition of intervention Receives: Drug: 0.5% bupivacaine heavy with fentanyl plus morphine 150mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the incidence of postoperative pain after cesarean section with different doses of intrathecal morphine with bupivacaine among the four groups.
The parturient among study groups receiving different dose of intrathecal morphine with bupivacaine were compared for incidence of postoperative cesarean section pain. The pain is assessed by using Numerical Pain Rating Scale(NRS) ,a 11-point, standardized tool (0-10) in which 0 means "no pain" and 10 means "the worst pain imaginable". The number of parturient with NRS more than 3 will be compared for postoperative pain among the 4 groups.
Measured: NRS score is measured in recovery room for postoperative pain assessment. This time will be recorded as "time zero". Then in postoperative ward, NRS score is measured at 2 hours, 4 hours, 6 hours, 12 hours and 24 hours from 'time zero".
Secondary outcomes (4)
To compare the first rescue analgesia demand time among the four groups
Rescue analgesia demand is defined as the first time after the cesarean section when the NRS score > 3, and analgesic will be needed. The time period after cesarean section when first rescue analgesic is needed will be compared among the four group. Inj.Ketorolac 30 mg iv will be supplemented first as rescue analgesic and recorded.
Measured: Postoperative period after cesarean delivery till 24 hour
To compare the total analgesic consumption in first 24 hours among the parturient of four group
Total analgesia consumption is defined as the total amount of paracetamol, ketorolac and tramadol received in the first 24 hours. From the time of first dose of ketorolac, regular analgesia will be prescribed as inj. ketorolac 30mg iv 8 hourly and inj. paracetamol 1gm iv 6 hourly for 24 hour. If the NRS score >3 at any point of time apart from the regular above medication, then Inj. tramadol 50 mg iv SOS will be provided and recorded. The number pf parturient with total analgesics consumption in 24 hour will be compared among the four groups.
Measured: Postoperative total analgesia consumption for first 24 hour
To compare the frequency of rescue analgesia demanded by parturient in first 24 hours among the groups
Frequency of rescue analgesia demand is measured by number of time patient with NRS >3 who demand for iv ketorolac, paracetamol and tramadol despite providing regular analgesia (inj ketorolac 30mg iv 8 hourly and inj.paracetamol 1gm iv 6 hourly) for 24 hour.
Measured: Postoperative period for first 24 hour
To compare the incidence of side effects like nausea, vomiting, respiratory depression, level of sedation and pruritus in first 24 hours among the groups
Number of parturient with treatment related side effects like nausea, vomiting, pruritus, respiratory depression and level of sedation are assessed and compared among the groups. Level of sedation is assessed by Pasero Opioid - Induced Sedation Scale (POSS) This score consist:
of : S Sleepy, easy to arouse
- Awake and alert
- Slightly drowsy, easily arousable
- Frequently drowsy, arousable, drift off to sleep during conversation
- Somnolent, minimal or no response to verbal or physical stimulation A POSS score of S, 1, or 2 indicates an acceptable level of sedation, whereas a score of 3 or 4 indicates over-sedation.
Measured: Postoperative period for first 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Apr 2026 (estimated)
- Primary completion28 Dec 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Cesarean Section 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
- Prospective double blinded, randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bashu Dev Parajuli, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560501
- Sponsor's protocol ID
- IRC/IOM/D-2026-339
- Other IDs
- NHRC 772-2025
- Acronym
- Analgesia
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient personal data will be kept confidential as our local IRC won't allow us to breach this policy.
Publications
Sultan P, Halpern SH, Pushpanathan E, Patel S, Carvalho B. The Effect of Intrathecal Morphine Dose on Outcomes After Elective Cesarean Delivery: A Meta-Analysis. Anesth Analg. 2016 Jul;123(1):154-64. doi: 10.1213/ANE.0000000000001255.
PubMed 27089000Choudhury M. Neuraxial anaesthesia in parturient with cardiac disease. Indian J Anaesth. 2018 Sep;62(9):682-690. doi: 10.4103/ija.IJA_474_18.
PubMed 30237593
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesia With Different Doses of Intrathecal Morphine With Hyperbaric Bupivacaine and Fentanyl in Cesarean Section Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07560501
- Acronym / sponsor ID
- Analgesia / IRC/IOM/D-2026-339
- Conditions
- Post Cesarean Section Pain
- Keywords
- Analgesia, Cesarean section, Intrathecal Morphine, Postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 1 May 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.
Central neuraxial blocks (CNBs) remain the preferred anesthetic technique for cesarean section, with single shot spinal anesthesia (SSSA) being the standard practice at investigator's institute unless contraindicated. SSSA offers reliable intraoperative anesthesia and provides a few hours of postoperative analgesia. Enhanced recovery after cesarean section protocol has recommended the addition of intrathecal (IT) morphine to improve the postoperative quality of the recovery profile. Fentanyl improves the quality of intraoperative analgesia, while morphine significantly prolongs the postoperative pain relief, often lasting up to 24 hours.
Routine uterine exteriorization, practiced in all cases at investigator's institute, often results in peritoneal stretching pain during surgery. This visceral pain is managed with 10 mcg intrathecal fentanyl added to hyperbaric bupivacaine. For postoperative pain management, the intrathecal morphine is recommended by many guidelines and studies. Intrathecal morphine dose typically ranges from 50 to 300 mcg. The dose of morphine exceeding 150 mcg are usually associated with prolongation of analgesia with higher incidence of side effects like nausea, vomiting and pruritus. In selected cases, investigator had administered morphine 100-150 mcg and the clinical experience has shown reduced postoperative analgesic requirements and favorable recovery profile, with minimal adverse effects.
Despite these promising experiences and extensive literature on IT morphine, their is still lack formal data on the efficacy and safety profile of IT morphine in cesarean section patient. This comparative study will help institute to find the optimum dose of IT morphine with better postoperative analgesia quality with low side effects profile. The finding could serve as a foundation to promote routine use of intrathecal morphine in cesarean section anesthesia at investigator's institute.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Prospective double blinded, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group BF | Active comparator | Drug: 0.5% bupivacaine heavy with fentanylIntrathecal drug used: 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml), total volume of 2.2ml, single administration, no repetition of intervention In this group, no dose of morphine will be added. |
| Group BF-M50 | Experimental | Drug: 0.5% bupivacaine heavy with fentanyl plus morphine 50 mcgIntrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml) plus morphine 50mcg (0.05ml) with total volume of 2.25ml single administration, no repetition of intervention |
| Group BF-M100 | Experimental | Drug: 0.5% bupivacaine heavy with fentanyl plus morphine100 mcgIntrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml) plus morphine 100mcg (0.1ml) with total volume of 2.3ml single administration, no repetition of intervention |
| Group BF-M150 | Experimental | Drug: 0.5% bupivacaine heavy with fentanyl plus morphine 150mcgIntrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml) plus morphine 150mcg (0.15ml) with total volume of 2.35ml single administration, no repetition of intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant lady > 36 weeks of gestation presenting for cesarean section under spinal anesthesia
- ASA II/ III
- Maternal Height > 150 cm
- BMI< 40 Kg/m2
- Elective Indication
Key exclusion criteria (3 listed)
- Patient unwilling to take part in the study
- Patient with known allergy to the study medications
- Contraindication to Spinal Anesthesia
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 |
|---|---|---|
| 0.5% bupivacaine heavy with fentanylSpinal anesthesia with 0.5% bupivacaine heavy with fentanyl at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile. | Drug | Group BF |
| 0.5% bupivacaine heavy with fentanyl plus morphine 50 mcgSpinal anesthesia with 0.5% bupivacaine heavy with fentanyl with morphine 50mcg at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile. | Drug | Group BF-M50 |
| 0.5% bupivacaine heavy with fentanyl plus morphine100 mcgSpinal anesthesia with 0.5% bupivacaine heavy with fentanyl with morphine 100mcg at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile. | Drug | Group BF-M100 |
| 0.5% bupivacaine heavy with fentanyl plus morphine 150mcgSpinal anesthesia with 0.5% bupivacaine heavy with fentanyl with morphine 150mcg at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile. | Drug | Group BF-M150 |
Primary outcome
To compare the incidence of postoperative pain after cesarean section with different doses of intrathecal morphine with bupivacaine among the four groups.
Time frame: NRS score is measured in recovery room for postoperative pain assessment. This time will be recorded as "time zero". Then in postoperative ward, NRS score is measured at 2 hours, 4 hours, 6 hours, 12 hours and 24 hours from 'time zero".
The parturient among study groups receiving different dose of intrathecal morphine with bupivacaine were compared for incidence of postoperative cesarean section pain. The pain is assessed by using Numerical Pain Rating Scale(NRS) ,a 11-point, standardized tool (0-10) in which 0 means "no pain" and 10 means "the worst pain imaginable". The number of parturient with NRS more than 3 will be compared for postoperative pain among the 4 groups.
4 secondary outcomes
To compare the first rescue analgesia demand time among the four groups
Time frame: Postoperative period after cesarean delivery till 24 hour
To compare the total analgesic consumption in first 24 hours among the parturient of four group
Time frame: Postoperative total analgesia consumption for first 24 hour
To compare the frequency of rescue analgesia demanded by parturient in first 24 hours among the groups
Time frame: Postoperative period for first 24 hour
To compare the incidence of side effects like nausea, vomiting, respiratory depression, level of sedation and pruritus in first 24 hours among the groups
Time frame: Postoperative period for first 24 hour
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 1 May 2026.
- Background: PubMed 27089000Sultan P, Halpern SH, Pushpanathan E, Patel S, Carvalho B. The Effect of Intrathecal Morphine Dose on Outcomes After Elective Cesarean Delivery: A Meta-Analysis. Anesth Analg. 2016 Jul;123(1):154-64. doi: 10.1213/ANE.0000000000001255.
- Background: PubMed 30237593Choudhury M. Neuraxial anaesthesia in parturient with cardiac disease. Indian J Anaesth. 2018 Sep;62(9):682-690. doi: 10.4103/ija.IJA_474_18.
- Individual participant dataSharing planned: No. Individual patient personal data will be kept confidential as our local IRC won't allow us to breach this policy.
Related trials for Post Cesarean Section Pain
Not yet recruiting
Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section
Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
Not yet recruiting
Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial
Pain, Postoperative Pain
Recruiting
Effects of Rehabilitation on Cesarean Scar Symptoms and Physical Recovery
Cesarean Birth, Massage
Recruiting
Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery
Pain, Analgesia
Not yet recruiting
LI4 and SP6 Acupuncture for Pain After Cesarean Delivery
Acute Postoperative Pain After Cesarean Delivery
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.5% bupivacaine heavy with fentanyl, 0.5% bupivacaine heavy with fentanyl plus morphine 50 mcg and 0.5% bupivacaine heavy with fentanyl plus morphine100 mcg in people with Post Cesarean Section Pain, 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 5 inclusion and 3 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 1 May 2026. 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. 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?
Contact Bashu Dev Parajuli, MD Anaesthesiology (00977+ 9851179038, bashuparajuli2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the incidence of postoperative pain after cesarean section with different doses of intrathecal morphine with bupivacaine among the four groups. (time frame: NRS score is measured in recovery room for postoperative pain assessment. This time will be recorded as "time zero". Then in postoperative ward, NRS score is measured at 2 hours, 4 hours, 6 hours, 12 hours and 24 hours from 'time zero".). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07560501, which also lists 2 linked publications.
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 1 May 2026.