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NCT01303120 Clinical Trial

Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief?

Post-operative Pain Clinical Trial

Official title:
Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief After Total Knee Arthroplasty or Should an Addition of Sciatic, Obturator and Lateral Femoral Cutaneous Nerve Blocks be Recommended?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01303120
Other study ID # 0021-11-HYMC
Secondary ID
Status Completed
Phase N/A
First received February 20, 2011
Last updated January 20, 2015
Start date May 2011
Est. completion date December 2013

Study information
Verified date February 2011
Source Hillel Yaffe Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the efficacy of the analgesic effect of the preoperative femoral nerve block alone versus combined femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks in patients after TKA in the immediate postoperative period.

Description:

Bupivacaine will be used for all the nerve blocks.

Recruitment information / eligibility
Status Completed
Enrollment 107
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 85 Years
Eligibility Inclusion Criteria:

- ASA I-III

- Undergoing two TKA

- Understanding PCA protocol

Exclusion Criteria:

- Skin infection near injection site

- Allergy to local analgesics

- Peripheral neuropathy

- Coagulopathy

- Dementia

- Proven opioid dependency

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Femoral Nerve Block
Preoperative Bupivacaine 0.5%, perineurally as single shot
• Combined nerve blocks
Preoperative Bupivacaine 0.5%, perineurally as single shot
• Patient-controlled analgesia
Patient controlled analgesia with morphine

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of single short femoral nerve block Three days No
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