CClinicalTrials.gg
Sign In
Status unknownNCT05459220Updated Jul 14, 2022

A Trial of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery

A Phase 3 interventional study of SHR0410 Injection and SHR0410 Injection in Postoperative Pain Of Laparoscopic Surgery, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-14.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
357
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after laparoscopic surgery

02

Conditions studied

  • Postoperative Pain Of Laparoscopic Surgery

Browse trials for

03

In context

Pain, Postoperative

5,095 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 357 is above the median of 75 across 4,346 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Able and willing to provide a written informed consent
  2. Subjects requiring elective general anesthesia endoscopic surgery of the lower abdominal
  3. Male or female
  4. Meet the body mass index standard
  5. Conform to the ASA Physical Status Classification

Exclusion criteria

Exclusion Criteria:

  1. Subjects with a history of difficult airway
  2. Subjects with a history of mental illness
  3. Subjects with a history of cognitive impairment epilepsy
  4. Subjects with a history of myocardial infarction or unstable angina pectoris
  5. Subjects with atrioventricular block or cardiac insufficiency
  6. Subjects with a history of ischemic stroke or transient ischemic attack
  7. Subjects with poor blood pressure control after medication
  8. Subject with a history of substance abuse and drug abuse
  9. Abnormal values in liver function
  10. Allergic to drugs that may be used during the study
  11. Pregnant or nursing women
  12. No birth control during the specified period of time
  13. Participated in clinical trials of other drugs (received experimental drugs)
  14. The investigators determined that other conditions were inappropriate for participation in this clinical trial
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
357 participants (estimated)

Study arms

  • Experimental
    Treatment group A

    SHR0410 Injection（Low Dose）

    Drug: SHR0410 Injection

  • Experimental
    Treatment group B

    SHR0410 Injection（High Dose）

    Drug: SHR0410 Injection

  • Placebo comparator
    Treatment group C

    Placebo for SHR0410 Injection.

    Drug: Placebo

Interventions

  • DrugSHR0410 Injection

    SHR0410 Injection（Low Dose）

  • DrugSHR0410 Injection

    SHR0410 Injection（High Dose）

  • DrugPlacebo

    Placebo for SHR0410 Injection.

06

What researchers measure

Primary outcomes

  1. Summed Pain Intensity Difference From 0-24 Hours (SPID0-24)

    Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity.

    Time frame: 0 to 24 hours

Secondary outcomes

  1. Summed Pain Intensity Difference Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours (SPID2、SPID4、SPID6、 SPID12、SPID18)

    Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity.

    Time frame: 0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours

  2. Estimated Time From The Start Of The Infusion Of Study Drug To The First NRS reaching 3 or less

    Time frame: 0 to 24 hours

  3. Total Pain Relief Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours、24 Hours

    Patients reported their pain relief using a 5-point(0-4) categorical scale (PR), with "0" indicating "No Relief", "1" indicating "A Little Relief", "2" indicating "Some Relief ", "3" indicating "A Lot of Relief" and "4" indicating "Complete Relief".

    Time frame: 0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours、0 to 24 hours

  4. Total consumption of remedial analgesics from 0 to 24 hours

    Time frame: 24-hours

  5. Participant' Satisfaction Score For Analgesia Treatment

    Time frame: 24-hours

  6. Investigator Satisfaction Score For Analgesia Treatment

    Time frame: 24-hours

  7. Numbers of Participants With Abnormal Vital Signs

    Changes in vital signs such as body temperature (using the celsius system) will be assessed at specified times.

    Time frame: Day 3 or Day 4

  8. Numbers of Participants With Abnormal Vital Signs

    Changes in vital signs such as, blood pressure (using mmHg) will be assessed at specified times.

    Time frame: Day 3 or Day 4

  9. Numbers of Participants With Abnormal Vital Signs

    Changes in vital signs such as , heart rate (measured by beats per minute) will be assessed at specified times.

    Time frame: Day 3 or Day 4

  10. Numbers of Participants With Abnormal Laboratory Values

    Participants with clinically significant lab values will be compared to those receiving placebo comparator.

    Time frame: Day 3 or Day 4

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05459220
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Jul 14, 2022
Start date
Jul 2022 (estimated)
Primary completion
Feb 28, 2023 (estimated)
Completion
Feb 28, 2023 (estimated)
Last update
Jul 14, 2022

Study contacts

Qin Liu
Contact
qin.liu@hengrui.com
+0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pain, Postoperative→

Other studies from this sponsor

Jiangsu HengRui Medicine Co., Ltd.

Start the discussion