Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator Nerve Blockade

NCT ID: NCT03064165

Last Updated: 2018-09-10

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

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2018-06-08

Brief Summary

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The study investigates the effect of an obturator nerve block on the postoperative pain and opioid consumption after total hip replacement.

Detailed Description

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Conditions

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Obturator Nerve Block Total Hip Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Obturator nerve block

Postoperative obturator nerve block with 15 mL bupivacain 5 mg/mL and epinephrine 5 µg/mL.

Group Type EXPERIMENTAL

Bupivacaine-epinephrine

Intervention Type DRUG

Nerve block with 15 mL bupivacain 5 mg/mL with epinephrine 5 µg/mL.

Obturator nerve block

Intervention Type PROCEDURE

Postoperative obturator nerve block

Sham block

Postoperative sham-block with normal saline.

Group Type PLACEBO_COMPARATOR

Sham block

Intervention Type PROCEDURE

Injection as for obturator nerve block, but with placebo

Sodium Chloride 9mg/mL

Intervention Type DRUG

Placebo

Interventions

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Bupivacaine-epinephrine

Nerve block with 15 mL bupivacain 5 mg/mL with epinephrine 5 µg/mL.

Intervention Type DRUG

Sham block

Injection as for obturator nerve block, but with placebo

Intervention Type PROCEDURE

Obturator nerve block

Postoperative obturator nerve block

Intervention Type PROCEDURE

Sodium Chloride 9mg/mL

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients for primary hip replacement in spinal anesthesia
* Age \>= 18 years
* American Society of Anesthesiologists physical status classification score I-III
* Informed consent

Exclusion Criteria

* Lacking the ability to corporate
* Lacking the ability to speak danish
* Planned discharge on the same day of surgery
* Neuropathy of the lower extremities
* Contraindications for NonSteroidal Anti-Inflammatory Drugs (NSAID)
* Contraindications for dexamethasone
* Chronic opioid demanding pain
* Pregnancy
* Allergy towards one or both investigatory medicinal products
* Active treatment with amiodarone
* Active treatment with verapamil
* Active treatment with corticosteroids
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elective Surgery Centre, Silkeborg Regional Hospital

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Niels Dalsgaard Nielsen

MD, PhD-fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Elective Surgery Centre

Silkeborg, , Denmark

Site Status

Countries

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Denmark

References

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Nielsen ND, Runge C, Clemmesen L, Borglum J, Mikkelsen LR, Larsen JR, Nielsen TD, Soballe K, Bendtsen TF. An Obturator Nerve Block does not Alleviate Postoperative Pain after Total Hip Arthroplasty: a Randomized Clinical Trial. Reg Anesth Pain Med. 2019 Jan 23:rapm-2018-100104. doi: 10.1136/rapm-2018-100104. Online ahead of print.

Reference Type DERIVED
PMID: 30679337 (View on PubMed)

Other Identifiers

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HIP/FUSION#2

Identifier Type: -

Identifier Source: org_study_id

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