Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06320041 |
| Other study ID # |
KY-2024-028 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2024 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
The Fourth Affiliated Hospital of Zhejiang University School of Medicine |
| Contact |
Dongmei Ma |
| Phone |
+8615267358077 |
| Email |
8019111[@]zju.edu.cn |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial] is to further explore the effectiveness and safety of
oxelidine in the treatment of moderate to severe acute pain after orthopedic surgery. The
main question it aims to answer is: Pain management after orthopaedic surgery provides more
effective and safe drug options, provides new options for clinical treatment, and provides a
scientific basis for clinical practice.
Participants will be asked to pain score in the different time, treatments they'll be given
and use optimal drug. Researchers will compare analgesic effect of oxelidine of different
dose.
Description:
Induction and maintenance of anesthesia were the same in all patients, performed by the same
anesthesiologist. The study Coordinator (Dr. He Kin Nang) used the Central randomization
System software to randomly assign high-dose oxelidine fumarate (group H), low-dose oxelidine
fumarate (group L) and hydromorphone (group M) in a ratio of 1:1:1. The distribution was
concealed using the same opaque envelopes, which were sealed and stored in a locked cabinet,
without the knowledge of the anesthesiologist and the follow-up physician.
The drugs for the study were prepared by an independent nurse anesthesiologist according to a
randomized outcome code, using the drug's configuration:
Group L: oxelidine fumarate (10ml, 20mg) + 190ml normal saline diluted to 200ml, PCIA
parameters were set as follows: background infusion rate was 0, self-controlled dosage was
0.35mg (3.5ml), locking time was 6min, load was 1.5mg; Group H: oxelidine fumarate (10ml,
20mg) + 190ml normal saline diluted to 200ml, PCIA parameters were set as follows: background
infusion rate was 0, self-controlled dosage was 0.5mg (i.e. 5ml), locking time was 6min, load
was 1.5mg; Group M: hydromorphone (6ml, 12mg) + normal saline (194ml) diluted to 200ml. PCIA
parameters were set as follows: background infusion rate was 0, self-controlled dosage was
0.3mg (5ml), locking time was 6min, and load was 1mg.
The PCIA pump starts from the withdrawal of the tracheal catheter. When the patient's pain
Numerical Evaluation Scale score (NRS) is ≥5, the effective pressure of the PCIA pump can be
increased for 1-3 times according to the actual pain sensation. If the pain is still not
relieved, the intravenous injection of hydromorphone 0.5-1mg (or drugs that can directly have
a conversion relationship with morphine) can be slowly injected. The PCIA pump is stopped 48
hours after surgery. If the patient still feels pain and the NRS score is ≥5, 5-10mg of
hydromorphone can be slowly injected intravenously (or drugs that can directly have a
conversion relationship with morphine). In both groups, 200mg celecoxib (400mg daily) was
taken orally at 08:00 and 16:00 each day from the first day after surgery (the second day of
the study) as a multimodal analgesic regimen until the patients stopped the drug after no
pain discomfort. If the study drug or remedial analgesic is still insufficient, the patient's
study drug therapy is discontinued and the usual analgesic therapy as determined by the
clinician is adopted.
Main study indicators: Area under the curve (AUC NRS-R0-72) of pain scores at rest 0-72 hours
after surgery in the three groups. Pain scores 0 hours after surgery were replaced by pain
scores 15 minutes after extubation.
Secondary study measures: The total amount of opioid relief analgesics converted into
morphine 0-72 hours after surgery in the three groups; Three groups first used PCIA as a
compression time for remedial analgesia; The area under the curve (AUCRNS-R0-72) of pain
scores during exercise in the three groups at 0-72 hours after surgery was replaced by the
pain scores during cough 15 minutes after extubation. NRS scores of resting and exercise at
different time points in the three groups within 72 hours after operation; Duration of
initial relief analgesia; 0-24h dosage of relief analgesic drugs; 0-48 hours of relief
analgesia; 0-48The total number of HPCA pump presses and effective presses; The proportion of
subjects who did not use remedial analgesia from 0 to 48h; Subject and investigator analgesic
satisfaction scores.
Safety assessment (follow-up up to day 3) : exposure, follow-up of adverse events (AEs),
respiration-related adverse events (hypoxemia, respiratory depression, hypoventilation),
upper respiratory tract reactions (nausea, vomiting), drowsiness or sedation, fever,
constipation, dizziness, headache, pruritus, etc.
