Comparison of Different Neural Blockade Techniques in Postoperative Analgesia After Total Hip Arthroplasty

July 25, 2017 updated by: Taichung Veterans General Hospital
To compare the different analgesic protocols for patients receiving total hip arthroplasty(THA). Patients will divided into 3 groups, which are 1. fascia iliaca compartment block with IV-PCA(patient controlled analgesia), 2. femoral nerve and lateral femoral cutaneous nerve block with IV-PCA, 3. IV-PCA only.

Study Overview

Status

Status

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

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.

Detailed Description

90 patients will be enrolled and randomized to the 3 different groups.

  1. Inclusion criteria:

    Patient undergoing THA: 20-75 years old, ASA I-III, general anesthesia with intubation, fentanyl IV PCA.

  2. Exclusion criteria Alcohol/substance abuse Rheumatoid arthritis Severe coagulation disorder(PLT<80000 or INR > 1.5) Peripheral neuropathy Allergy to opioids or local anesthetics BMI>35
  3. The outcome followers are blinded to the intervention provided.

  4. Outcome parameters:

    1. Opioid consumption of IV PCA in first 24 hrs.
    2. NSAID consumption

    3. NRS of pain, the timings of follow-up should be: pre-block, 30

      mins post-block, 60 mins post-block, 2 hours post-block, 24hours post-block

    4. sensory block in FN, Obturator Nerve and LFCN
    5. First request of supplemental IV analgesia

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 (Anticipated)

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.
90

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.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
      • Taichung, Taiwan
        • Recruiting
        • Dept. of Anesthesiology, Taichung Veterans General Hospital
        • Contact:

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I-III, general anesthesia with intubation.
  • fentanyl IV PCA

Exclusion Criteria:

  • Alcohol/substance abuse
  • Rheumatoid arthritis
  • Severe coagulation disorder(PLT<80000 or INR > 1.5)
  • Peripheral neuropathy
  • Allergy to opioids or local anesthetics
  • BMI>35

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: Triple

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.
Active Comparator: fascia iliaca compartment block+ IV-PCA
Procedure: Fascia iliaca compartment block with IV-PCA
1. Fascia iliaca compartment block: The injection was performed under ultrasound guidance. Surface landmark is identified on the line between anterior superior iliac spine and pubic tubercle. The injection site is at the medial one-third of the line. The needle is threaded medial to lateral and standardization of local anesthetic deposit is in the fascia plane between fascia iliaca and iliacus muscle. Anesthetic regimen: 2% xylocaine 15mL + 0.5% bupivacaine 15mL.
Active Comparator: femoral nerve and lateral femoral cutaneous nerve block+IV PCA
Procedure: Femoral nerve block and lateral femoral cutaneous nerve with IV-PCA
  1. Femoral nerve block: The injection was performed under ultrasound guidance. Femoral nerve was identified in the femoral neurovascular bundle below or around inguinal ligament. The needle is threaded with lateral to medial approach. Local anesthetics will be deposited around the femoral nerve, the standardization of protocol is that femoral nerve should be lifted off from iliacus muscle. Anesthetic regimen: 2% xylocaine 10mL + 0.5% bupivacaine 10mL.
  2. Lateral femoral cutaneous nerve block: The injection was performed under ultrasound guidance. Lateral femoral cutaneous nerve was identified in the fascia plane between sartorius muscle and tensor fascia lata muscle. Anesthetic regimen: 2% xylocaine 5mL + 0.5% bupivacaine 5mL
Placebo Comparator: IV PCA only
Procedure: IV-PCA
IV-PCA was programmed and provided to the patient for optimize pain control

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
Temporal changes of Pain score
Time Frame: 1. Pre-intervention(which is the time when operation was done and the patient arrive postoperative care unit.) 2. 30 minutes after intervention, 3. 60 minutes after intervention, 4. 120 minutes after intervention, 5. 24 hours after intervention.
Pain score by numerical rating scale from pre-intervention to 24 hours after intervention(the effect of neural blockade seldom lasts more than 24 hours)
1. Pre-intervention(which is the time when operation was done and the patient arrive postoperative care unit.) 2. 30 minutes after intervention, 3. 60 minutes after intervention, 4. 120 minutes after intervention, 5. 24 hours after intervention.

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
Opioid consumptions
Time Frame: postoperatively 24 hours
Including IV-PCA and other analgesics
postoperatively 24 hours
Sensory block in femoral nerve, obturator nerve and lateral femoral cutaneous nerve area
Time Frame: 1 hour post-intervention
1 hour post-intervention
NSAID consumptions
Time Frame: 24 hours postoperatively
24 hours postoperatively

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.
Taichung Veterans General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yi-Ting Chang, M.D., Taichung Veterans General 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

  • 1. Hadzic's peripheral nerve blocks and anatomy for ultrasound-guidedregional anesthesia, 2012. Chapter.35, 36. 2. K.H. Thymo, O. Mathiesen, J.B. Dahl, et al. Lateral femoral cutaneous nerve block after total hip arthroplasty: a randomized trial. Acta Anaesthesiologica Scandinavica 60(2016) 1297-1305. 3. Shoji Nishio, Shigeo Fukunishi, Miura Juichi et al. Comparison of continuous femoral nerve block, caudal epidural block, and intravenous patient-controlled analgesia in pain control after total hip arthroplasty: a prospective randomized study. Orthopedic Reviews 2014; 6; 5138. 4. Bin Yu, Miao He, Guang-Yu Cai et al. Ultrasound-guided continuous femoral nerve block vs continuous fascia iliaca compartment block for hip replacement in the elderly. Medicine (2016) 95:42 5. Guay J, Parker MJ, Gajendragadkar PR, et al. Anaesthesia for hip fracture surgery in adults. Cochrane Database of Systemic Reviews 2016, issue 2, Art. No:CD000521. 6. K.H. Thybo, Harald Schmidt and Daniel Hagi-Pederson. Effect of lateral femoral cutaneous nerve block on pain after total hip arthroplasty: a randomized , blinded, placebo-controlled trail. BMC anesthesiology (2016) 16:21. 7. John Dolan, Anne Williams, Eileen Murney, et al. Ultrasound guided fascial iliaca block: a comparison with loss of resistance technique. Reg Anesth Pain Med 2008; 33: 526-31 8. Ali N. Shariat, Admir Hadzic, Daquan Xu, et al. Fascia iliaca block for analgesia after hip arthroplasty: a randomized double-blinded, placebo-controlled trial. Reg Anesth Pain Med 2013;38:201-205

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 (Anticipated)

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.
July 27, 2017

Primary Completion (Anticipated)

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.
April 19, 2018

Study Completion (Anticipated)

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.
April 19, 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).
June 22, 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.
July 25, 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.
July 27, 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.
July 27, 2017

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.
July 25, 2017

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.
July 1, 2017

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.
  • CF17089A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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