The Efficacy and Safety of Oxycodone in Patient-controlled Intravenous Analgesia After Laparoscopic Hysterectomy
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- NRS scores
Study Overview
Brief Summary
This study is designed to evaluate the efficacy and safety of hydrocodone in patient-controlled intravenous analgesia (PCIA) during gynecological laparoscopy, thus to explore suitable PCIA scheme to optimize postoperative pain management for patients undergoing gynecological laparoscopic surgeries.
Detailed Description
The controlled group will receive sulfentanil for PCIA, and the test group will receive hydrocodone for PCIA. NRS scores at 1, 6, 24 and 48 hours post-surgery will be recorded. The usage of rescue analgesics and adverse events will also be recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •selective laparoscopic hysterectomy
- •general anesthesia
- •ASA classification I - III
- •aged 18 - 65 years
Exclusion Criteria
- •allergy to oxycodone or any other drugs will be used in the study
- •preoperative opioids medication
- •opioids abuse
- •hepatic or renal dysfunction
- •cardiovascular or pulmonary dysfunction
- •lack of full civil capacity or refuse to participate
Outcomes
Primary Outcomes
NRS scores
Time Frame: 6 hours after surgery
Postoperative pain will be evaluated on a 11point number rating scale (NRS): 0 means no pain; and 10 means worst pain imaginable.
Secondary Outcomes
- NRS scores(30 days after surgery)
- rescue analgesics usage(from the end of surgery to the first usage (up to 48 hours post-surgery))
- PCIA pressing times(48 hours after surgery)
- anal exhaust time(from the end of surgery to the first anal exhaust (up to 48 hours post-surgery))
- adverse events(within 48 hours after surgery)
Investigators
Siyuan Liu
Principal Investigator
Affiliated Hospital of Nantong University