Laparoscopic HysterectomyPhase 4OxycodoneNCT06690307
Oxycodone Versus Sufentanil in Patient-controlled Intravenous Analgesia After Laparoscopic Hysterectomy
A Phase 4 study of Laparoscopic Hysterectomy, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Laparoscopic Hysterectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2024to 31 Jul 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- selective laparoscopic hysterectomy
- general anesthesia
- ASA classification I - III
- aged 18 - 65 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated hospital of Nantong University
Nantong, Jiangsu, 226001
Wei Shi, 0513-85052297, jsrdwbb@126.com
About this study
Official title: The Efficacy and Safety of Oxycodone in Patient-controlled Intravenous Analgesia After Laparoscopic Hysterectomy
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.
Read the 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.
- Conditions
- Laparoscopic Hysterectomy
- Being tested
- patient controlled intravenous analgesia(PCIA)
- Keywords
- oxycodone, patient-controlled intravenous analgesia, laparoscopic hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient controlled intravenous analgesia(PCIA)Procedure or surgery
Patients will receive sulfentanil for PCIA.
patient controlled intravenous analgesia(PCIA)Procedure or surgery
Patients will receive oxycodone for PCIA.
| Study group | Role | What they receive |
|---|---|---|
| sulfentanil group | Active comparator | Participants in the active comparator group will receive sulfentanil for PCIA. Receives: Procedure: patient controlled intravenous analgesia(PCIA) |
| oxycodone group | Experimental | Participants in the experimental group will receive oxycodone for PCIA. Receives: Procedure: patient controlled intravenous analgesia(PCIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS scores
Postoperative pain will be evaluated on a 11point number rating scale (NRS): 0 means no pain; and 10 means worst pain imaginable.
Measured: 6 hours after surgery
Secondary outcomes (6)
NRS scores
Postoperative pain will be evaluated on a 11point number rating scale (NRS): 0 means no pain; and 10 means worst pain imaginable.
Measured: 1, 24, 48 hours after surgery
rescue analgesics usage
time to the first use of rescue analgesics
Measured: from the end of surgery to the first usage (up to 48 hours post-surgery)
PCIA pressing times
total pressing times and effective pressing times
Measured: 48 hours after surgery
anal exhaust time
Measured: from the end of surgery to the first anal exhaust (up to 48 hours post-surgery)
adverse events
dizziness, drowsiness, nausea and vomiting, intestinal paralysis, skin itching, respiratory depression, intestinal obstruction, severe allergic reactions, and serious cardiovascular adverse events
Measured: within 48 hours after surgery
NRS scores
Postoperative pain will be evaluated on a 11point number rating scale (NRS): 0 means no pain; and 10 means worst pain imaginable.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start3 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic HysterectomyStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siyuan Liu, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690307
- Sponsor's protocol ID
- 2024-K115-01
- Acronym
- Oxycodone
- Status last verified
- Dec 2024
- First submitted
- 9 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Oxycodone in Patient-controlled Intravenous Analgesia After Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT06690307
- Acronym / sponsor ID
- Oxycodone / 2024-K115-01
- Conditions
- Laparoscopic Hysterectomy
- Keywords
- oxycodone, patient-controlled intravenous analgesia, laparoscopic hysterectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 15 Nov 2024 (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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sulfentanil group | Active comparator | Procedure: patient controlled intravenous analgesia(PCIA)Participants in the active comparator group will receive sulfentanil for PCIA. |
| oxycodone group | Experimental | Procedure: patient controlled intravenous analgesia(PCIA)Participants in the experimental group will receive oxycodone for PCIA. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- selective laparoscopic hysterectomy
- general anesthesia
- ASA classification I - III
- aged 18 - 65 years
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| patient controlled intravenous analgesia(PCIA)Patients will receive sulfentanil for PCIA. | Procedure or surgery | sulfentanil group |
| patient controlled intravenous analgesia(PCIA)Patients will receive oxycodone for PCIA. | Procedure or surgery | oxycodone group |
Primary outcome
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.
6 secondary outcomes
NRS scores
Time frame: 1, 24, 48 hours after surgery
rescue analgesics usage
Time frame: from the end of surgery to the first usage (up to 48 hours post-surgery)
PCIA pressing times
Time frame: 48 hours after surgery
anal exhaust time
Time frame: from the end of surgery to the first anal exhaust (up to 48 hours post-surgery)
adverse events
Time frame: within 48 hours after surgery
NRS scores
Time frame: 30 days after 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 4 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Laparoscopic Hysterectomy, run by Affiliated Hospital of Nantong University at 1 site in China.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Siyuan Liu, PhD (+86-85050301, tdfylsy@ntu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS scores (time frame: 6 hours after surgery). 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 4 Dec 2024.