Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03648008
Other study ID # 2018-014
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 5, 2018
Est. completion date September 1, 2018

Study information

Verified date August 2018
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Postoperative pain remains relatively high within 48h for Chinese patients who receive video-assisted thoracoscopic surgery. Multimodal analgesia combines several agents and/or techniques to function on diverse nociceptive mechanisms to enhance pain relief and lessen side effect. Hydromorphone is a hydrogenated ketone of morphine and approximately 5-10 times more potent. There lacks about efficacy and efficiency of hydromorphone in electrical pump for patient controlled intravenous analgesic (PCIA).


Recruitment information / eligibility

Status Completed
Enrollment 171
Est. completion date September 1, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 70= Age =18

- Selective operation lung section with video-assisted thoracic surgery (VATS)

- III = American Society of Anesthesiologists classification (ASA classification) =I

- Patients informed and agreed to join the study

Exclusion Criteria:

- Abnormal function of liver and kidney

- Allergic- dependence history of alcohol, opioids and Local anesthetics

- No noncompliance

- Mental disease history,language communication disorder,cicatricial diathesis

- Underweight or overweight(BMI<18 or >30)

- Patients not suitable for clinical subjects for other reasons

- Sedatives, analgesics, antiemetic drugs and anti pruritus drugs were used within 24 hours before the operation.

- History of previous abnormal anaesthesia

- Women during pregnancy or lactation

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Hydromorphone
0.002 mg*kg-1 bolus with 0.002 mg*kg-1 background infusion for group BH 0.002 mg*kg-1 bolus without background infusion for group NBH Drug is administered through PCIA pump.
Morphine
0.015 mg*kg-1 bolus without background infusion for group M Drug is administered through PCIA pump.

Locations

Country Name City State
China The second affiliated hospital of Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rest pain assessment at 0.5 hour after tracheal extubation Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better. 0.5 hour after tracheal extubation
Primary Rest pain assessment at 8 p.m. surgery day Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better. 8 p.m. at surgery day
Primary Activity pain assessment at 8 p.m. surgery day Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better. 8 p.m. at surgery day
Primary Rest pain assessment at 8 a.m. at first day after surgery Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better. 8 a.m. at first day after surgery
Primary Activity pain assessment at 8 a.m. at first day after surgery Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better. 8 a.m. at first day after surgery
Primary Rest pain assessment at 8 p.m. at first day after surgery Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better. 8 p.m. at first day after surgery
Primary Activity pain assessment at 8 p.m. at first day after surgery Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better. 8 p.m. at first day after surgery
Primary Rest pain assessment at 8 a.m. at second day after surgery Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better. 8 a.m. at second day after surgery
Primary Activity pain assessment at 8 a.m. at second day after surgery Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better. 8 a.m. at second day after surgery
Primary Rest pain assessment at 8 p.m. at second day after surgery Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better. 8 p.m. at second day after surgery
Primary Activity pain assessment at 8 p.m. at second day after surgery Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better. 8 p.m. at second day after surgery
Primary Rest pain assessment at 8 a.m. at third day after surgery Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better. 8 a.m. at third day after surgery
Primary Activity pain assessment at 8 a.m. at third day after surgery Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better. 8 a.m. at third day after surgery
Primary Rest pain assessment at 8 p.m. at third day after surgery Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better. 8 p.m. at third day after surgery
Primary Activity pain assessment at 8 p.m. at third day after surgery Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better. 8 p.m. at third day after surgery
Secondary Ratio of Nausea Record whether patients experience nausea 8 p.m. at surgery day
Secondary Ratio of Vomiting Record whether patients experience vomiting and how many times do they experience 8 p.m. at surgery day
Secondary Ratio of Nausea Record whether patients experience nausea 8 a.m. at first day after surgery
Secondary Ratio of Vomiting Record whether patients experience vomiting and how many times do they experience 8 a.m. at first day after surgery
Secondary Ratio of Nausea Record whether patients experience nausea 8 p.m. at first day after surgery
Secondary Ratio of Vomiting Record whether patients experience vomiting and how many times do they experience 8 p.m. at first day after surgery
Secondary Ratio of Nausea Record whether patients experience nausea 8 a.m. at second day after surgery
Secondary Ratio of Vomiting Record whether patients experience vomiting and how many times do they experience 8 a.m. at second day after surgery
Secondary Ratio of Nausea Record whether patients experience nausea 8 p.m. at second day after surgery
Secondary Ratio of Vomiting Record whether patients experience vomiting and how many times do they experience 8 p.m. at second day after surgery
Secondary Ratio of Nausea Record whether patients experience nausea 8 a.m. at third day after surgery
Secondary Ratio of Vomiting Record whether patients experience vomiting and how many times do they experience 8 a.m. at third day after surgery
Secondary Ratio of Nausea Record whether patients experience nausea 8 p.m. at third day after surgery
Secondary Ratio of Vomiting Record whether patients experience vomiting and how many times do they experience 8 p.m. at third day after surgery
Secondary Total Analgesia usage Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump 8 p.m. at surgery day
Secondary Total Antiemetic usage Sum up any antiemetic 8 p.m. at surgery day
Secondary Total Analgesia usage Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point 8 a.m. at first day after surgery
Secondary Total Antiemetic usage Sum up any antiemetic from last time point 8 p.m. at first day after surgery
Secondary Total Analgesia usage Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point 8 p.m. at first day after surgery
Secondary Total Analgesia usage Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point 8 a.m. at second day after surgery
Secondary Total Antiemetic usage Sum up any antiemetic from last time point 8 a.m. at second day after surgery
Secondary Total Analgesia usage Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point 8 p.m. at second day after surgery
Secondary Total Antiemetic usage Sum up any antiemetic from last time point 8 p.m. at second day after surgery
Secondary Total Analgesia usage Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point 8 a.m. at third day after surgery
Secondary Total Antiemetic usage Sum up any antiemetic from last time point 8 a.m. at third day after surgery
Secondary Total Analgesia usage Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point 8 p.m. at third day after surgery
Secondary Total Antiemetic usage Sum up any antiemetic from last time point 8 p.m. at third day after surgery
See also
  Status Clinical Trial Phase
Completed NCT05480111 - The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy Phase 4
Completed NCT06129305 - Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
Completed NCT04401826 - Micro-surgical Treatment of Gummy Smile N/A
Recruiting NCT04020133 - the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction. N/A
Completed NCT03023462 - Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair N/A
Completed NCT03546738 - Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery N/A
Completed NCT03652103 - Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy Phase 4
Terminated NCT03261193 - ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain Phase 3
Withdrawn NCT03528343 - Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy Phase 1/Phase 2
Completed NCT02525133 - Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty Phase 3
Completed NCT03244540 - Regional Analgesia After Cesarean Section Phase 4
Enrolling by invitation NCT05316168 - Post Operative Pain Management for ACL Reconstruction Phase 3
Recruiting NCT04130464 - Intraperitoneal Infusion of Analgesic for Postoperative Pain Management Phase 4
Enrolling by invitation NCT04574791 - Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty N/A
Completed NCT04073069 - Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults Phase 4
Completed NCT04526236 - Influence of Aging on Perioperative Methadone Dosing Phase 4
Recruiting NCT05351229 - Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery Phase 4
Enrolling by invitation NCT05543109 - Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block N/A
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Completed NCT04919317 - Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty Phase 2