Evaluation of safety and efficacy of Nalbuphine versus Morphine patient controlled intravenous analgesia (PCIA) for the treatment of postoperative analgesia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
288
PCIA,The lockout interval is set at 10 minutes, with no background infusion.
PCIA,The lockout interval is set at 10 minutes, with no background infusion.
Peking University First Hospital
Beijing, China
Sum of Pain Intensity Difference over 0-48 hours(SPID48)
SPID48=∑PID48×\[time in hours slapsed since the previous observation\], PID48 denotes the pain intensity difference at time 48 hours after the first administration relative to baseline. The pain intensity is rated using an 11-point numeric scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable."
Time frame: 0-48 hours
Sum of Pain Intensity Difference over 0-12 hours(SPID12)
SPID12=∑PID12×\[time in hours slapsed since the previous observation\], PID12 denotes the pain intensity difference at time 12 hours after the first administration relative to baseline. The pain intensity is rated using an 11-point numeric scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable."
Time frame: 0-12 hours
Sum of Pain Intensity Difference over 0-24 hours(SPID24)
SPID24=∑PID24×\[time in hours slapsed since the previous observation\], PID24 denotes the pain intensity difference at time 24 hours after the first administration relative to baseline. The pain intensity is rated using an 11-point numeric scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable."
Time frame: 0-24 hours
Sum of Pain Intensity Difference over 0-32 hours(SPID32)
SPID32=∑PID32×\[time in hours slapsed since the previous observation\], PID32 denotes the pain intensity difference at time 32 hours after the first administration relative to baseline. The pain intensity is rated using an 11-point numeric scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable."
Time frame: 0-32 hours
Total Number of PCIA Pump attempts during 0~48h
The PCIA protocol was implemented as follows: For subjects with baseline NRS scores ≥4, investigators administered the first PCIA bolus to initiate analgesia.The exact time of investigator's first PCIA activation was recorded as D0-0h. PCIA Pump Settings: Experimental Group: 2 mg per demand dose (2 mL/dose); Control Group: 1 mg per demand dose (2 mL/dose); Lockout Interval: 10 minutes. Background Infusion: None. Subsequent Analgesia Management: Following initial activation, subjects self-administered additional PCIA doses as needed based on pain levels. Subsequent PCIA Use: Subjects self-administer additional PCIA doses as needed based on pain levels. PCIA Discontinuation \& Data Collection: At 48 hours (±20 min) after the first study drug administration (or upon early withdrawal), study staff will: pause and disconnect the PCIA pump, Record: total number of PCIA presses, number of effective presses and total dosage of study drug delivered via PCIA
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Cangzhou People's Hospital
Cangzhou, China
RECRUITINGThe First People's Hospital of Changde City
Changde, China
RECRUITINGThe Third Xiangya Hospital of Central South Univerdity
Changsha, China
RECRUITINGHeping Hospital affiliated to Changzhi Medical College
Changzhi, China
RECRUITINGChengdu Fifth People's Hospital
Chengdu, China
RECRUITINGSichuan Provincial People's Hospital
Chengdu, China
RECRUITINGChongqing University Affiliated Fuling Central Hospital
Chongqing, China
RECRUITINGDeyang People's Hospital
Deyang, China
RECRUITINGThe First Affiliated Hospital of Fujian Medical University
Fuzhou, China
RECRUITING...and 14 more locations
Time frame: 0-48 hours
Number of Effective Deliveries during 0~48h
The PCIA protocol was implemented as follows: For subjects with baseline NRS scores ≥4, investigators administered the first PCIA bolus to initiate analgesia.The exact time of investigator's first PCIA activation was recorded as D0-0h. PCIA Pump Settings: Experimental Group: 2 mg per demand dose (2 mL/dose); Control Group: 1 mg per demand dose (2 mL/dose); Lockout Interval: 10 minutes. Background Infusion: None. Subsequent Analgesia Management: Following initial activation, subjects self-administered additional PCIA doses as needed based on pain levels. Subsequent PCIA Use: Subjects self-administer additional PCIA doses as needed based on pain levels. PCIA Discontinuation \& Data Collection: At 48 hours (±20 min) after the first study drug administration (or upon early withdrawal), study staff will: pause and disconnect the PCIA pump, Record: total number of PCIA presses, number of effective presses and total dosage of study drug delivered via PCIA
Time frame: 0-48 hours
Total Delivered Dose during 0~48h
The PCIA protocol was implemented as follows: For subjects with baseline NRS scores ≥4, investigators administered the first PCIA bolus to initiate analgesia.The exact time of investigator's first PCIA activation was recorded as D0-0h. PCIA Pump Settings: Experimental Group: 2 mg per demand dose (2 mL/dose); Control Group: 1 mg per demand dose (2 mL/dose); Lockout Interval: 10 minutes. Background Infusion: None. Subsequent Analgesia Management: Following initial activation, subjects self-administered additional PCIA doses as needed based on pain levels. Subsequent PCIA Use: Subjects self-administer additional PCIA doses as needed based on pain levels. PCIA Discontinuation \& Data Collection: At 48 hours (±20 min) after the first study drug administration (or upon early withdrawal), study staff will: pause and disconnect the PCIA pump, Record: total number of PCIA presses, number of effective presses and total dosage of study drug delivered via PCIA
Time frame: 0-48 hours
Time to First Use of Rescue Medication
Time to first use of rescue medication during 0\~48h.(For subjects with inadequate pain control (NRS score ≥4) who consent to rescue therapy, the following conditions must be met before administering rescue medication: 1) NRS score remains ≥4 within 5 minutes prior to rescue drug administration; 2) At least 5 minutes have elapsed since the last effective PCIA pump press, and the next PCIA bolus is not yet due)
Time frame: 0-48 hours
Proportion of Subjects Requiring Rescue Medication
Time frame: 0-48 hours
Number of Rescue Medication Administrations
Time frame: 0-48 hours
Proportion of Subjects with Treatment Failure
Time frame: 0-48 hours
Patient Global Impression of Change (PGIC) at 48 Hours Post-Dose
The PGIC scale (6-point) will be administered at 48h (±30min) post-dose to evaluate patients' perceived change in analgesia, ranging from 'Very much improved' (1) to 'Much worse' (6).
Time frame: 0-48 hours