Actively Recruiting
The Efficacy and Safety of Oxycodone in Patient-controlled Intravenous Analgesia After Laparoscopic Hysterectomy
Led by Affiliated Hospital of Nantong University · Updated on 2024-12-04
64
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of oxycodone compared to sulfentanil in patient-controlled intravenous analgesia (PCIA) for managing pain after gynecological laparoscopic hysterectomy. This Phase 4 study aims to find the best PCIA approach to improve postoperative pain control for patients undergoing these surgeries. Participants will be randomly assigned to one of two groups: one group will receive sulfentanil through PCIA, while the other group will receive oxycodone through PCIA. Pain levels will be measured using Numeric Rating Scale (NRS) scores at 1, 6, 24, and 48 hours after surgery. The study will also monitor the use of additional pain relief medications and any adverse events. During the trial, participants will have their pain assessed regularly and will be observed for any side effects or complications within 48 hours post-surgery. Other measures include the number of times the PCIA device is pressed, time to first anal exhaust, and pain scores up to 30 days after surgery. The total participation period includes these assessments to ensure comprehensive monitoring of pain management and safety.
CONDITIONS
Brief Title
Oxycodone Versus Sufentanil in Patient-controlled Intravenous Analgesia After Laparoscopic Hysterectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Selective laparoscopic hysterectomy
- General anesthesia
- ASA classification I to III
- Female aged 18 to 65 years
You will not qualify if you...
- Allergy to oxycodone or any other drugs used in the study
- Preoperative opioid medication
- History of opioid abuse
- Hepatic or renal dysfunction
- Cardiovascular or pulmonary dysfunction
- Lack of full civil capacity or refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 hours after surgery
Participants receive patient-controlled intravenous analgesia (PCIA) with either oxycodone or sulfentanil after laparoscopic hysterectomy.
1 hospital stay including continuous monitoring up to 48 hours post-surgery
Duration - 30 days after surgery
Participants are assessed for pain scores and adverse events up to 30 days after surgery.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Affiliated hospital of Nantong University
Nantong, Jiangsu, China, 226001
Actively Recruiting
Research Team
S
Siyuan Liu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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