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

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?

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Pain
• Intervention / Treatment: Drug: Femoral Nerve Block; Drug: Combined nerve blocks; Drug: Patient-controlled analgesia

Detailed Description

Bupivacaine will be used for all the nerve blocks.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Femoral Nerve Block	Drug: Femoral Nerve Block; Preoperative Bupivacaine 0.5%, perineurally as single shot
Active Comparator: Combined Nerve Blocks	Drug: Combined nerve blocks; Preoperative Bupivacaine 0.5%, perineurally as single shot
Active Comparator: Patient-controlled analgesia	Drug: Patient-controlled analgesia; Patient controlled analgesia with morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of single short femoral nerve block	Three days

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center

Publications and helpful links

General Publications

• Stav A, Reytman L, Sevi R, Stav MY, Powell D, Dor Y, Dudkiewicz M, Bayadse F, Sternberg A, Soudry M. Femoral versus Multiple Nerve Blocks for Analgesia after Total Knee Arthroplasty. Rambam Maimonides Med J. 2017 Jan 30;8(1):e0006. doi: 10.5041/RMMJ.10281.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: February 20, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 20, 2015
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 0021-11-HYMC