Comparison of Three Kinds of Postoperative Analgesia After Total Knee Arthroplasty

• Sponsor: Guangzhou General Hospital of Guangzhou Military Command (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02094339
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 3
• Duration (Months): 27
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pain; Complications	Procedure: Local analgesic; Procedure: Nerve Block; Procedure: Intravenous analgesic; Drug: ropivacaine; Drug: ropivacaine; Drug: opioid	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Three Kinds of Postoperative Analgesia After Total Knee Arthroplasty :a Randomized Clinical Trial
• Study Start Date: Mar 1, 2014
• Anticipated Primary Completion Date: Jun 1, 2016
• Anticipated Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. pain [72 hours postoperation]

   Up to 72 hours after operation,postoperative pain visual analogue scale(VAS) scores are used to evaluate the level of pain.

Secondary Outcome Measures

1. sedation [72 hours postoperation]

   At 2, 4, 6, 12, 24, 36, 48,72 hours after operation,sedation OAA/S scores are used to evaluate the level of sedation.

2. complication [72 hours postoperation]

   Investigators document the incidence of nausea,vomiting,headache,urinary retention and et al.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Guangzhou Military Region General Hospital, Department of Anesthesiology	Guangzhou	Guangdong	China	510010

Sponsors and Collaborators

• Guangzhou General Hospital of Guangzhou Military Command

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command
• ClinicalTrials.gov Identifier: NCT02094339
• Other Study ID Numbers: Unilateral Knee Replacement
• First Posted: Mar 21, 2014
• Last Update Posted: Mar 12, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command: Local analgesia system; Ropivacaine; Analgesic efficacy after operation; Postoperative
• Additional relevant MeSH terms: Analgesics; Ropivacaine

Study Results

No Results Posted as of Mar 12, 2015