Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine

April 12, 2022 updated by: Hospital for Special Surgery, New York

Patients scheduled to go home after ankle surgery at HSS typically receive a sciatic nerve block in the popliteal fossa and oral analgesic tablets (such as Percocet). Popliteal fossa nerve blockade has reduced pain for these patients (YaDeau et al, Anesth Analg 2008;106:1916-20), but unfortunately the patients still often experience moderate to severe pain after the block wears off. The investigators wish to study two additives that may prolong the period of analgesia provided by the nerve block. The additives will be studied in the context of a standardized postoperative multimodal analgesic pathway.

Primary outcome:

Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?

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.
108

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 Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients of Dr Levine or Dr Roberts.
  2. Scheduled for discharge from HSS after foot or ankle surgery.
  3. A single-injection popliteal fossa nerve block is judged appropriate.
  4. Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion).
  5. Patients aged 18-75 years.

Exclusion Criteria:

  • Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac crest bone graft).
  • Bilateral surgery
  • Chronic pain (defined as regular use of opioid analgesics for > 3 months).
  • Chronic use of steroids (defined as regular use of steroids for > 3 months).
  • Contraindication to performance of the popliteal fossa nerve block with 30 cc 0.25% bupivacaine with clonidine (e.g. alleged bupivacaine sensitivity, low body weight, clonidine allergy, etc.).
  • Contraindications to dexamethasone or buprenorphine (e.g. allergy, Insulin Dependent Diabetes Mellitus, etc.)
  • Inability of the patient to describe postoperative pain (e.g. psychiatric disorder, dementia).
  • Non-English speaking patients (the questionnaire is in English, and translations would have to be separately validated)

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.
Experimental: Control Nerve Block. IV Dexamethasone (4 mg).
Control Nerve Block. IV Dexamethasone (4 mg).
Drug: A. Control Nerve Block. IV Dexamethasone (4 mg).
A. Control Nerve Block. IV Dexamethasone (4 mg).
Experimental: Nerve Block with Dexamethasone (4 mg). IV saline.
B. Nerve Block with Dexamethasone (4 mg). IV saline.
Drug: B. Nerve Block with Dexamethasone (4 mg). IV saline.
B. Nerve Block with Dexamethasone (4 mg). IV saline.
Experimental: Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp
Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
Drug: C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
Experimental: Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (
Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
Drug: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
Experimental: Nerve Block with Dexamethasone (4 mg) / block Buprenorphine
Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
Drug: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).
E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.

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
Time it Takes for Nerve Block to Wear Off
Time Frame: up to 72 hours
Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?
up to 72 hours

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.
Hospital for Special Surgery, New York

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.
  • Principal Investigator: Michael Urban, Hospital for Special Surgery, New York

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

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.
October 1, 2010

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.
December 1, 2011

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.
December 1, 2011

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 13, 2011

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 13, 2011

First Posted (Estimate)

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 14, 2011

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.
April 14, 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.
April 12, 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.
April 1, 2022

More Information

Terms related to this study

Keywords

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.
  • 2012-042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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