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The comparison of local infiltration(extra-articular) sustained-release analgesia and epidural analgesia for pain relief and functional outcome: A randomized controlled trial

The comparison of local infiltration(extra-articular) sustained-release analgesia and epidural analgesia for pain relief and functional outcome: A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029655
Enrollment
Unknown
Registered
2020-02-09
Start date
2017-08-01
Completion date
Unknown
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis

Interventions

epidural analgesia group:Epidural analgesia device(Henan ostrich Medical Equipment Co., Ltd., China), Ropivacaine,Morphine Hydrochloride,Saline
local infiltration(extra-articular) sustained-release analgesia group:Disposable local infiltration analgesia device(Beijing Tongji Hengyuan Medical Technology Co., Ltd., China),Ropivacaine,Morphine H

Sponsors

Department of orthopaedic surgery, The Fourth Affiliated Hospital, Zhejiang University, School of Medicine, Yiwu 322000, ZheJiang, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) patients requiring the bilateral knee arthroplasty due to the degenerative osteoarthritis, the conservative treatment is ineffective; (2) The patients receiving the epidural anesthesia, American Society of Anesthesiologists (ASA) classification (anesthesia risk assessment) is the I ~ II level; (3) the patients willing to receive the staged bilateral surgery, the interval of the operation will be more than 3 months; (4) aged 50 to 80 years; (5) the patients have the ability to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. The patient unwilling to be enrolled in the trial; 2. The patient has a cognitive or sensory impairment and cannot understand the visual analogue score; 3. allergic to anesthetic drugs and sulfa; 4. Failure of combined spinal and epidural anesthesia; 5. The patient had previous surgery on the knee joint or had a history of knee injury.

Design outcomes

Primary

MeasureTime frame
Visual analogure score;Postoperative consumption of remedial morphine hydrochloride;Range of knee motion;

Secondary

MeasureTime frame
Quadriceps strength;Incidence of postoperative nausea and vomitting;

Countries

China

Contacts

Public ContactLe-Yi Huang

Department of orthopaedic surgery, The Fourth Affiliated Hospital, Zhejiang University, School of Medicine, Yiwu 322000, ZheJiang, China

8011023@zju.edu.cn+86 13575719854

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026