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

NCT ID: NCT01303120

Last Updated: 2015-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Bupivacaine will be used for all the nerve blocks.

Conditions

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Post-operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Femoral Nerve Block

Group Type ACTIVE_COMPARATOR

Femoral Nerve Block

Intervention Type DRUG

Preoperative Bupivacaine 0.5%, perineurally as single shot

Combined Nerve Blocks

Group Type ACTIVE_COMPARATOR

Combined nerve blocks

Intervention Type DRUG

Preoperative Bupivacaine 0.5%, perineurally as single shot

Patient-controlled analgesia

Group Type ACTIVE_COMPARATOR

Patient-controlled analgesia

Intervention Type DRUG

Patient controlled analgesia with morphine

Interventions

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Femoral Nerve Block

Preoperative Bupivacaine 0.5%, perineurally as single shot

Intervention Type DRUG

Combined nerve blocks

Preoperative Bupivacaine 0.5%, perineurally as single shot

Intervention Type DRUG

Patient-controlled analgesia

Patient controlled analgesia with morphine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hillel Yaffe Medical Center

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 28178436 (View on PubMed)

Other Identifiers

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0021-11-HYMC

Identifier Type: -

Identifier Source: org_study_id

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