This is a randomized, double-blind, active drug- and placebo-controlled, dose-escalation clinical study conducted in patients scheduled to undergo abdominal surgery. It aims to evaluate the tolerability, safety, pharmacokinetics, and efficacy of SYH9089 Injection for postoperative analgesia in these patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Before the surgical incision was closed, SYH9089 injection was applied to the incision wound.
Before the surgical incision was closed, 0.5% ropivacaine hydrochloride was injected into the incision wound.
Before the surgical incision was closed, the incision wound was infiltrated with 0.9% sodium chloride injection.
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGAdverse Event Profile
Participants with an Adverse Event through 14 days
Time frame: 14 days
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores
The AUC of NRS-R during 0-6 h,0-12 h,0-24 h,0-48 h,0-72 h,0-96 h,0-120 h,24-48 h,48-72 h,24-72 h,72-96 h,and 96-120 h after administration. Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain.
Time frame: 0 to 120 hours
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores
The AUC of NRS-A during 0-6 h,0-12 h,0-24 h,0-48 h,0-72 h,0-96 h,0-120 h,24-48 h,48-72 h,24-72 h,72-96 h,and 96-120 h after administration. Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain.
Time frame: 0 to 120 hours
Cumulative use of rescue analgesics during each period
Cumulative amount of rescue analgesics used during 0-6 h,0-12 h,0-24 h,0-48 h,0-72 h,0-96 h,0-120 h,24-48 h,48-72 h,24-72 h,72-96 h,and 96-120 h after administration.
Time frame: 0 to 120 hours
Proportion of participants not requiring rescue analgesia in each period
Proportion of participants not requiring rescue analgesia within 0-6 h,0-12 h,0-24 h,0-48 h,0-72 h,0-96 h,0-120 h,24-48 h,48-72 h,24-72 h,72-96 h,and 96-120 h after administration.
Time frame: 0 to 120 hours
Proportion of participants with an NRS-A score ≤ 1 at different time points.
Proportion of participants with an NRS-A score ≤ 1 at 6 h, 12 h, 24 h, 48 h, 72 h, 96 h, and 120 h after administration.
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Time frame: 0 to 120 hours
Proportion of participants with an NRS-R score ≤ 1 at different time points.
Proportion of participants with an NRS-R score ≤ 1 at 6 h, 12 h, 24 h, 48 h, 72 h, 96 h, and 120 h after administration.
Time frame: 0 to 120 hours
Time of first morphine rescue analgesia
The time from administration to the first morphine rescue analgesic treatment
Time frame: 0 to 120 hours
Participant's Analgesic Satisfaction Score
Participant satisfaction will be assessed at 120 hours after administration.
Time frame: 0 to 120 hours
Investigator Satisfaction Score
Investigator satisfaction will be assessed at 120 hours after administration
Time frame: 0 to 120 hours