Butorphanol for Pain Relief After Cesarean Section: A Retrospective Study

NCT07175363 | Not Yet Recruiting

• 1 other identifier: 2025-598
• Study Type: observational
• Target: 2,500
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Keywords

Caesarean section

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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).

  2 days post-surgery

Secondary Outcomes (3)

• Overall patient satisfaction rating

  2 days post-surgery

• Nausea and vomiting

  2 days post-surgery

• Adverse reactions

  2 days post-surgery

Study Arms (1)

The group using the analgesic pump

Drug: An postoperative analgesic pump was used

Interventions

An postoperative analgesic pump was used DRUG

The drugs in the analgesic pump include butorphanol, hydromorphone, tramadol, and other medications.

The group using the analgesic pump

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who have given birth by cesarean section

You may qualify if:

• 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

You may not qualify if:

• Postoperative analgesia pump usage time is less than 24 hours
• Missing key information such as follow-up status in medical records

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician-in-charge

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 16, 2025
• Study Start: September 20, 2025
• Primary Completion: September 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share