Trial record 3 of 2311 for:    Open Studies | "Analgesics"

Comparison of Three Kinds of Postoperative Analgesia After Total Knee Arthroplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Guangzhou General Hospital of Guangzhou Military Command
Sponsor:
Information provided by (Responsible Party):
bo xu, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier:
NCT02094339
First received: March 19, 2014
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

Postoperative pain after total knee arthroplasty (TKA) can be difficult to manage and may delay recovery. There are multimodal postoperative pain management after TKA, including intravenous opioids, epidural analgesia, peripheral nerve blocks or periarticular infiltration with local anesthetics. All of these treatments may lead to side effects such as nausea, headache, hypotension, urinary retention, partial motor block and infection of the knee. Therefore the investigators will compare three methods of postoperative analgesic after TKA by their efficiency and complication.


Condition Intervention Phase
Pain
Complications
Procedure: Local analgesic
Procedure: Nerve Block
Procedure: Intravenous analgesic
Drug: ropivacaine
Drug: opioid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Three Kinds of Postoperative Analgesia After Total Knee Arthroplasty :a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Guangzhou General Hospital of Guangzhou Military Command:

Primary Outcome Measures:
  • pain [ Time Frame: 72 hours postoperation ] [ Designated as safety issue: No ]
    Up to 72 hours after operation,postoperative pain visual analogue scale(VAS) scores are used to evaluate the level of pain.


Secondary Outcome Measures:
  • sedation [ Time Frame: 72 hours postoperation ] [ Designated as safety issue: No ]
    At 2, 4, 6, 12, 24, 36, 48,72 hours after operation,sedation OAA/S scores are used to evaluate the level of sedation.

  • complication [ Time Frame: 72 hours postoperation ] [ Designated as safety issue: No ]
    Investigators document the incidence of nausea,vomiting,headache,urinary retention and et al.


Estimated Enrollment: 45
Study Start Date: March 2014
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Local analgesic
This group uses local analgesia infusion pump of 0.2% ropivacaine 360ml through periarticular infiltration for postoperative analgesia.
Procedure: Local analgesic
Patient will be performed under combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine.At the end of surgery,two catheters are left in the wound.One is intraarticular and the other is on the surface of articular cavity.And then a pump elastomeric infusion pump will be connected with the catheters, which runs 5mL every hours.
Drug: ropivacaine
0.2% ropivacaine
Active Comparator: Nerve Block
People in this group will receive a postoperative pain management by continuous lumbar plexus block with 0.2% ropivacaine.
Procedure: Nerve Block
Combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine will be performed before the surgery.After the a bolus of 30mL ropivacaine around lumbar plexus,a catheter will be left in Psoas gap with 6cm.A pump elastomeric infusion pump running 5mL every hours will also be connected with the catheters at the end of the operation.
Drug: ropivacaine
0.2% ropivacaine
Active Comparator: Intravenous analgesic
This group is treated with intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg.
Procedure: Intravenous analgesic
People in this group will also receive an anesthesia of combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine.An intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg will will provide postoperative pain management.The patients will received a 2 mL/h continuous basal infusion and 1 mL boluses with a lockout time of 30 min after a 5 mL Loading dose at the end of the surgery.
Drug: opioid
flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients of American Association of anesthetists(ASA)Grade 1、2 or 3
  2. Aged between 18 and 85 years
  3. Undergoing elective total knee replacement

Exclusion Criteria:

  1. Mental illness can not match
  2. Nerve block, epidural anesthesia contraindicated
  3. People who have Slow-type arrhythmias
  4. History of chronic headaches and long-term use of analgesic drugs
  5. People who were postoperative consciousness, language or hearing impaired
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02094339

Contacts
Contact: bo xu, associate chief physician 88653387 ext 020 xubo333@hotmail.com

Locations
China, Guangdong
Guangzhou Military Region General Hospital, Department of Anesthesiology Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Tao Zhi Li    15625052815 ext 86    lytow@qq.com   
Sponsors and Collaborators
Guangzhou General Hospital of Guangzhou Military Command
  More Information

Publications:
Responsible Party: bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT02094339     History of Changes
Other Study ID Numbers: Unilateral Knee Replacement
Study First Received: March 19, 2014
Last Updated: March 20, 2014
Health Authority: China: Ethics Committee

Keywords provided by Guangzhou General Hospital of Guangzhou Military Command:
Local analgesia system
Ropivacaine
Analgesic efficacy after operation
Postoperative

Additional relevant MeSH terms:
Analgesics
Analgesics, Opioid
Analgesics, Non-Narcotic
Flurbiprofen axetil
Ropivacaine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 31, 2014