MED90 of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain in Spinal Anesthesia Positioning

January 25, 2022 updated by: Wei Mei, Huazhong University of Science and Technology

Minimum Effective Dose of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain for Spinal Anesthesia in Patients With Hip Fracture

This study aims to determine the minimum effective dose of ropivacaine for peripheral nerve block on posture-evoked pain for spinal anesthesia in elderly patients with hip fracture. Three types of peripheral nerve block, including fascia iliaca block, femoral nerve block and Pericapsular nerve group block (PENG block) will be assessed.

Study Overview

Status

Status

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

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

Patients with hip fractures are anticipated to endure sever pain caused by positional changes required for spinal anesthesia. Providing analgesia before positioning not only increases patient comfort but also improves positioning and successful spinal block. Peripheral nerve block is an effective strategy for relieving pain during postures change for spinal anesthesia in patients with hip fractures. Three types of peripheral nerve block, including fascia iliaca block, femoral nerve block and Pericapsular nerve group block (PENG block), has been successfully used for analgesia for spinal anesthesia positioning in patients with hip fractures. However, the minimum effective dose of local anesthetics for these three types of peripheral nerve block is not known. This study aims to determine the minimum effective dose of ropovacaine in the three types of peripheral nerve block using a biased coin design up-and-down sequential method. Successful block is defined as NRS score ≤3 by positional changes for spinal anesthesia, achieved at 20min after the block. MED90 of ropivacaine for fascia iliaca block, femoral nerve block and PENG block be assessed respectively. Patients will receive ultrasound guided peripheral nerve block. The initial dose is chosen as 80 mg on the basis of clinical experience. Subsequently, if a patient has an inadequate block, the ropivacaine dose is increased by 8 mg in the next subject. If a patient has a successful block, the next subject is randomized to receive either a lower dose (with a decrement of 8 mg), with a probability of b = 0.11, or the same dose, with a probability of 1 - b = 0.89. Forty five successful blocks for each type of nerve block will be accomplished. MED90 of each type of nerve block will be calculated by isotonic regression.

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.
180

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

  • China
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Department of Anesthesiology, Tongji Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wei Mei

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

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 65 - 85 years
  • American Society of Anesthesiologists physical statusⅠ- Ⅲ
  • Patients will receive hip replacement

Exclusion Criteria:

  • Patient refusal
  • Cognitive impairment(NRS pain score cannot be assessed)
  • Peripheral neuropathy
  • Mutiple furacture
  • skin infection at the site of injection
  • allergy to ropivacaine、lidocaine or bupivacaine
  • contraindication to spinal anesthesia

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

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: Fascia iliaca block
ultrasound-guided fascia iliaca block with predetermined dose of 0.4% ropivacaine will be performed.
Procedure: Fascia iliaca block
Fascia iliaca block will be performed under ultrasound guidenance.
Experimental: Femoral nerve block
ultrasound-guided ultrasound-guided femoral nerve block with predetermined dose of 0.4% ropivacaine will be performed.
Procedure: Femoral nerve block
Femoral nerve block will be performed under ultrasound guidenance.
Experimental: Pericapsular nerve group block (PENG block)
ultrasound-guided ultrasound-guided pericapsular nerve group block with predetermined dose of 0.4% ropivacaine will be performed.
Procedure: Pericapsular nerve group block (PENG block)
Pericapsular nerve group block (PENG block) will be performed under ultrasound guidenance.

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
The minimum effective dose of ropivacaine in three types of nerve block for analgesia for spinal anesthesia positioning in patients with hip fractures
Time Frame: up to 24 months
The minimum effective dose of ropivacaine in each type of nerve block is based on 45 patients with satisfactory analgesia during positioning for spinal anesthesia.
up to 24 months

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.
Huazhong University of Science and Technology

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.
January 25, 2022

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.
May 1, 2024

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.
May 15, 2024

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).
January 9, 2021

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.
January 9, 2021

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.
January 12, 2021

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.
February 9, 2022

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.
January 25, 2022

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.
January 1, 2022

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.
  • MEDNB-HP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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