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

September 7, 2018 updated by: Niels Dalsgaard Nielsen, University of Aarhus

Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Silkeborg, Denmark, DK-8600
        • Elective Surgery Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Obturator nerve block
Postoperative obturator nerve block with 15 mL bupivacain 5 mg/mL and epinephrine 5 µg/mL.
Drug: Bupivacaine-epinephrine
Nerve block with 15 mL bupivacain 5 mg/mL with epinephrine 5 µg/mL.
Procedure: Obturator nerve block
Postoperative obturator nerve block
Placebo Comparator: Sham block
Postoperative sham-block with normal saline.
Procedure: Sham block
Injection as for obturator nerve block, but with placebo
Drug: Sodium Chloride 9mg/mL
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Opioid dose 0-12 hour after total hip replacement
Time Frame: 0-12 hour after completion of total hip replacement
Cumulated dose of opioid 0-12 hour after total hip replacement
0-12 hour after completion of total hip replacement

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumulated dose of opioid 12-18 hours after total hip replacement.
Time Frame: 12-18 hours after completion of total hip replacement
12-18 hours after completion of total hip replacement
Pain at rest at time of examination (numeric rating scale)
Time Frame: 1, 2, 5, 7 and 24 hours after completion of total hip replacement
1, 2, 5, 7 and 24 hours after completion of total hip replacement
Pain at passive 90-degree hip flexion (numeric rating scale)
Time Frame: 1, 2, 5, 7 and 24 hours after completion of total hip replacement
1, 2, 5, 7 and 24 hours after completion of total hip replacement
Worst pain during ambulation on the day of surgery
Time Frame: 5 hours after completion of total hip replacement
5 hours after completion of total hip replacement
Time from completion of surgery to first dose of opioid
Time Frame: 24 hours after completion of total hip replacement
24 hours after completion of total hip replacement
Intensity of nausea on time of examination (numeric rating scale)
Time Frame: 1, 2, 5, 7 and 24 hours after completion of total hip replacement
1, 2, 5, 7 and 24 hours after completion of total hip replacement
Incidences of emesis 0-18 hours after total hip replacement.
Time Frame: 0-18 hours after completion of total hip replacement
0-18 hours after completion of total hip replacement
Cumulated dose of ondansetron 0-18 hours after total hip replacement
Time Frame: 0-18 hours after completion of total hip replacement
0-18 hours after completion of total hip replacement
Cumulated dose of droperidol 0-18 hours after total hip replacement
Time Frame: 0-18 hours after completion of total hip replacement
0-18 hours after completion of total hip replacement
Length of stay on post anesthesia care unit after completion of total hip replacement
Time Frame: 24 hours after completion of total hip replacement
24 hours after completion of total hip replacement
Length of stay on hospital after completion of total hip replacement
Time Frame: Up to 2 days
Up to 2 days
Ability to ambulate 5 hours after surgery
Time Frame: 5 hours after completion of total hip replacement
Ability to sit, stand, walk with tall rollator and walk with crutches
5 hours after completion of total hip replacement
Motor control with operated leg
Time Frame: 5 hours after completion of total hip replacement
Physiotherapist evaluating motor control with operated leg during ambulation.
5 hours after completion of total hip replacement
Self-reported sleep quality the first night after total hip replacement
Time Frame: 24 hours after completion of total hip replacement
Self-reported sleep quality on a 3-point-scale: 2 = Undisturbed sleep; 1 = Sleep disturbed by other reasons than pain; 0 = Sleep disturbed by pain.
24 hours after completion of total hip replacement
Duration of spinal anesthesia
Time Frame: 0-4 hours after completion of total hip replacement
Time from end of operation until regain of normal sensibility on anterior femur.
0-4 hours after completion of total hip replacement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Elective Surgery Centre, Silkeborg Regional Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 8, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 8, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HIP/FUSION#2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data will be shared through the Danish Data Archive.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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