Comparison of Three Kinds of Postoperative Analgesia After Total Knee Arthroplasty

Pain Clinical Trial

Official title:

Comparison of Three Kinds of Postoperative Analgesia After Total Knee Arthroplasty :a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02094339
• Other study ID #: Unilateral Knee Replacement
• Status: Recruiting
• Phase: Phase 4
• First received: March 19, 2014
• Last updated: March 11, 2015
• Start date: March 2014
• Est. completion date: June 2016

Study information

• Verified date: March 2015
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: bo xu, associate chief physician
• Phone: 88653387
• Email: xubo333[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complications
• Pain

Intervention

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.
• 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.
• 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:
• ropivacaine
0.2% ropivacaine
• ropivacaine
0.2% ropivacaine
• opioid
flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg

Locations

Country	Name	City	State
China	Guangzhou Military Region General Hospital, Department of Anesthesiology	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

References & Publications (2)

Serpell MG, Millar FA, Thomson MF. Comparison of lumbar plexus block versus conventional opioid analgesia after total knee replacement. Anaesthesia. 1991 Apr;46(4):275-7. — View Citation

Toftdahl K, Nikolajsen L, Haraldsted V, Madsen F, Tønnesen EK, Søballe K. Comparison of peri- and intraarticular analgesia with femoral nerve block after total knee arthroplasty: a randomized clinical trial. Acta Orthop. 2007 Apr;78(2):172-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	Up to 72 hours after operation,postoperative pain visual analogue scale(VAS) scores are used to evaluate the level of pain.	72 hours postoperation	No
Secondary	sedation	At 2, 4, 6, 12, 24, 36, 48,72 hours after operation,sedation OAA/S scores are used to evaluate the level of sedation.	72 hours postoperation	No
Secondary	complication	Investigators document the incidence of nausea,vomiting,headache,urinary retention and et al.	72 hours postoperation	No