Analgesia, Patient-Controlled Clinical Trial
Official title:
Comparison of Oxycodone and Sufentanil for Analgesic Efficacy After Hip Surgery: a Prospective, Multicenter Randomized Controlled Trial
Verified date | January 2024 |
Source | West China Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
We design this randomized controlled trial to compare the safety and efficacy of Oxycodone and Sufentanil for postoperative patient-controlled analgesia in patients undergoing hip surgery, with a view to finding the optimal postoperative analgesic regime with fewer adverse reactions and promoting patients' rehabilitation.
Status | Enrolling by invitation |
Enrollment | 570 |
Est. completion date | July 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients undergoing unilateral hip surgery, sign the "informed consent form" - Age above 18 years old Exclusion Criteria: - Pregnant or lactating women - Patients with history of drug abuse, including but not limited to opioids, amphetamines, ketamine, etc - Allergic to opioids - Have history of nervous system diseases such as peripheral neuropathy, or psychiatric mental illness - Other conditions that the investigators consider unsuitable for participation in the study, such as deaf, Parkinson's disease, and difficult to communication etc |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital, Sichuan University | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
West China Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of post operative nausea and vomiting (PONV) | The proportion of subjects who experienced PONV | Up to 72 hours after operation | |
Primary | Postoperative numerical rating scales (NRS) at rest | Resting NRS pain scores at 2 h after surgery. | Up to 72 hours after operation | |
Secondary | Postoperative NRS on movement | Postoperative NRS pain score on movement, up to 72hr. | Up to 72 hours after operation | |
Secondary | Postoperative complications | Incidence of postoperative adverse reactions and complications | Up to 30 days after operation | |
Secondary | Residual amount of drug | Residual amount of drug in the analgesic pump. | Up to 72 hours after operation | |
Secondary | Length of stay (LOS) in hospital | Time frame from the day of hospital admission to discharge from the hospital (unit: days) | Up to 30 days after operation | |
Secondary | Postoperative LOS | Time frame from the day of operation to discharge from the hospital (unit: days). | Up to 30 days after operation | |
Secondary | Re-admission rate | The incidence of re-admission within 30 days after surgery. | Up to 30 days after operation | |
Secondary | Total in-hospital cost. | Total hospitalization expenses after the destruction of costly consumables in orthopedic operation. | Up to 30 days after operation | |
Secondary | Time from the end of operation to the first onset of PONV | Time from the end of operation to the first onset of PONV | Up to 30 days after operation | |
Secondary | The severity of first PONV and the most severe PONV | The severity of PONV is scored from 0 to 10, and 0 represents no PONV at all, and 10 represents very severe PONV. | Up to 30 days after operation | |
Secondary | Motion of hip joints | Range of motion of hip joints during 3 days after operation. | Up to 72 hours after operation | |
Secondary | Straight leg raising time | Time from the end of operation to the time that patient can raise his affected lower limb by himself (Unit: hour). | Up to 72 hours after operation | |
Secondary | Ground exercise time | Time from the end of operation to the time that patient can do the ground exercise by himself (Unit: hour). | Up to 72 hours after operation | |
Secondary | Mobilization time | Time frame from the end of operation to able to walk without external assistance (Walking aids such as crutches can be used, unit: hour). | Up to 72 hours after operation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04111328 -
the Effect of Different Drugs and Infusion Ways on Degree of Postoperative Comfort
|
Phase 4 | |
Recruiting |
NCT03488888 -
PEC Block II in Mammoplasty Surgeries
|
N/A | |
Completed |
NCT00800826 -
The Combination Effect of Dexmedetomidine and Morphine in Postoperative Patient-Controlled Analgesia
|
Phase 4 | |
Recruiting |
NCT03919916 -
Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia in Rib Fractures
|
N/A | |
Completed |
NCT03585088 -
The Prediction for Postoperative Pain
|
N/A | |
Completed |
NCT00996177 -
A Study to Compare Patient-controlled Pain Medications Delivered Either Through the Skin or Intravenously
|
Phase 4 | |
Completed |
NCT06316921 -
Epidural PCA on Pain Relief After L-spine Surgery
|
||
Recruiting |
NCT05691101 -
Comparison of Using CIBPB With or Without IV-PCA After Arthroscopic Rotator Cuff Repair
|
N/A | |
Terminated |
NCT03846102 -
MORphine Use in the Fascia Iliaca Compartment Block With UltraSound
|
Phase 4 | |
Unknown status |
NCT02503826 -
The Efficacy and Optimal Dose of Sufentanil in Patient Controlled Analgesia After Moderate Surgery
|
Phase 4 | |
Completed |
NCT01275547 -
The Analgesic Effect of Combined Treatment With Intranasal S-ketamine and Intranasal Midazolam
|
Phase 2/Phase 3 | |
Recruiting |
NCT03813225 -
Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (SERRINT)
|
N/A | |
Completed |
NCT05188794 -
Comparison of Two Different Approach TAP Block on Pain Management of Laparoscopic Nephrectomy
|
N/A | |
Recruiting |
NCT05672225 -
Two-channel IV-PCA With Dexmedetomidine
|
N/A | |
Completed |
NCT03252977 -
Tailored PCA Based on Preoperative Pain Sensitivity
|
N/A | |
Recruiting |
NCT05299866 -
The Effect of S-ketamine Combined With Sufentanil for Postoperative Analgesia in Patients Following Cesarean Section
|
Phase 4 | |
Completed |
NCT03007121 -
Intrathecal Morphine Analgesia vs. Continuous Epidural Analgesia vs. Systemic Analgesia in Colorectal Surgery.
|
Phase 4 |