Caesarean SectionNCT07175363
Butorphanol for Pain Relief After Cesarean Section: A Retrospective Study
An observational study of Caesarean Section, run by Sichuan Provincial People's Hospital.
Trial summary
This study explored the association between postoperative functional recovery and the formula of analgesic pumps as well as other related factors (such as age, intraoperative blood loss, operation duration, etc.) by retrospectively analyzing the clinical data of patients undergoing cesarean section in the main campus… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Caesarean Section
- What is being tested?
- An postoperative analgesic pump was used
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2025to 30 Jun 2026
- Phase
- Observational
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who have given birth by cesarean section
Who may be able to join
- Age 18-55 years
- ASAI-III level
- Scheduled or emergency cesarean section
- Postoperative use of analgesic pump (formulation includes buprenorphine or tramadol or hydromorphone, etc.)
- Complete electronic medical records
Who cannot join
- Postoperative analgesia pump usage time is less than 24 hours
- Missing key information such as follow-up status in medical records
About this study
Official title: The Application of Butorphanol in Postoperative Analgesia Management After Cesarean Section: A Retrospective Cohort Study
This study explored the association between postoperative functional recovery and the formula of analgesic pumps as well as other related factors (such as age, intraoperative blood loss, operation duration, etc.) by retrospectively analyzing the clinical data of patients undergoing cesarean section in the main campus and branches of Sichuan Provincial People's Hospital from September 2024 to June 2025. The value of this study lies in: 1) providing a basis for optimizing the postoperative analgesia plan after cesarean section. 2) To provide references for the formulation of personalized analgesia strategies in clinical practice, improve the postoperative recovery quality of patients, promote the concept of enhanced recovery after surgery, and reduce the medical burden.
- Conditions
- Caesarean Section
- Being tested
- An postoperative analgesic pump was used
- Keywords
- Caesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An postoperative analgesic pump was usedDrug
The drugs in the analgesic pump include butorphanol, hydromorphone, tramadol, and other medications.
| Study group | Role | What they receive |
|---|---|---|
| The group using the analgesic pump | Not described Receives: Drug: An postoperative analgesic pump was used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
The Visual Analog Scale (VAS) is primarily used, where 1 represents no pain (best outcome) and 10 represents the worst pain (worst outcome); other scales may be used if necessary.
Measured: 2 days post-surgery
Postoperative functional recovery status
Postoperative functional recovery status mainly includes: the time of first passage of gas, the time of first ambulation, the time of first catheter removal, and the recovery of limb muscle strength. The passage of gas, ambulation, and catheter removal times are self-reported by the patients, recording the days after surgery when the events occurred. The recovery of limb muscle strength is classified into six levels, ranging from 0 to 5, where 0 indicates no detectable muscle contraction (worst outcome) and 5 indicates normal muscle strength (best outcome).
Measured: 2 days post-surgery
Sedation score
The sedation score uses a scale from -5 to +4, where -5 is defined as coma (one of the worst outcomes); -4 is defined as severe sedation (responds to physical stimulation); -3 is moderate sedation (no response to auditory stimulation); -2 is mild sedation (unable to maintain alertness for more than 10 seconds); -1 is drowsiness (not fully awake but can stay awake for more than 10 seconds); 0 is the awake natural state (best outcome); +1 is restlessness and anxiety (anxious and tense, but only slight body movement); +2 is agitation and anxiety (intense body movement); +3 is very agitated (trying to remove body tubes); +4 is aggressive (violent behavior) (one of the worst outcomes).
Measured: 2 days post-surgery
Secondary outcomes (3)
Overall patient satisfaction rating
Patient overall satisfaction is self-reported, with a score range from 0 to 100, where 0 represents the least satisfied (worst outcome) and 100 represents the most satisfied (best outcome).
Measured: 2 days post-surgery
Nausea and vomiting
Self-reported by the patient, with '1' indicating occurrence (worst outcome) and '0' indicating non-occurrence (best outcome).
Measured: 2 days post-surgery
Adverse reactions
Measured: 2 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean SectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanyu Liu, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175363
- Sponsor's protocol ID
- 2025-598
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Butorphanol in Postoperative Analgesia Management After Cesarean Section: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07175363
- Acronym / sponsor ID
- 2025-598
- Conditions
- Caesarean Section
- Keywords
- Caesarean section
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 16 Sep 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.
This study explored the association between postoperative functional recovery and the formula of analgesic pumps as well as other related factors (such as age, intraoperative blood loss, operation duration, etc.) by retrospectively analyzing the clinical data of patients undergoing cesarean section in the main campus and branches of Sichuan Provincial People's Hospital from September 2024 to June 2025. The value of this study lies in: 1) providing a basis for optimizing the postoperative analgesia plan after cesarean section. 2) To provide references for the formulation of personalized analgesia strategies in clinical practice, improve the postoperative recovery quality of patients, promote the concept of enhanced recovery after surgery, and reduce the medical burden.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The group using the analgesic pump | – | Drug: An postoperative analgesic pump was used |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who have given birth by cesarean section
Key inclusion criteria (5 listed)
- Age 18-55 years
- ASAI-III level
- Scheduled or emergency cesarean section
- Postoperative use of analgesic pump (formulation includes buprenorphine or tramadol or hydromorphone, etc.)
- Complete electronic medical records
Key exclusion criteria (2 listed)
- Postoperative analgesia pump usage time is less than 24 hours
- Missing key information such as follow-up status in medical records
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 |
|---|---|---|
| An postoperative analgesic pump was usedThe drugs in the analgesic pump include butorphanol, hydromorphone, tramadol, and other medications. | Drug | The group using the analgesic pump |
Primary outcome
Pain Score
Time frame: 2 days post-surgery
The Visual Analog Scale (VAS) is primarily used, where 1 represents no pain (best outcome) and 10 represents the worst pain (worst outcome); other scales may be used if necessary.
Postoperative functional recovery status
Time frame: 2 days post-surgery
Postoperative functional recovery status mainly includes: the time of first passage of gas, the time of first ambulation, the time of first catheter removal, and the recovery of limb muscle strength. The passage of gas, ambulation, and catheter removal times are self-reported by the patients, recording the days after surgery when the events occurred. The recovery of limb muscle strength is classified into six levels, ranging from 0 to 5, where 0 indicates no detectable muscle contraction (worst outcome) and 5 indicates normal muscle strength (best outcome).
Sedation score
Time frame: 2 days post-surgery
The sedation score uses a scale from -5 to +4, where -5 is defined as coma (one of the worst outcomes); -4 is defined as severe sedation (responds to physical stimulation); -3 is moderate sedation (no response to auditory stimulation); -2 is mild sedation (unable to maintain alertness for more than 10 seconds); -1 is drowsiness (not fully awake but can stay awake for more than 10 seconds); 0 is the awake natural state (best outcome); +1 is restlessness and anxiety (anxious and tense, but only slight body movement); +2 is agitation and anxiety (intense body movement); +3 is very agitated (trying to remove body tubes); +4 is aggressive (violent behavior) (one of the worst outcomes).
3 secondary outcomes
Overall patient satisfaction rating
Time frame: 2 days post-surgery
Nausea and vomiting
Time frame: 2 days post-surgery
Adverse reactions
Time frame: 2 days post-surgery
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 16 Sep 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of Caesarean Section, run by Sichuan Provincial People's Hospital.
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 2 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 16 Sep 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Pain Score (time frame: 2 days post-surgery). The study lists 3 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 16 Sep 2025.