NCT02198235

Brief Summary

This study looks at addition of medications to the local anesthetic for the nerve blockade.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_1 postoperative-pain

Timeline
Completed

Started Oct 2012

Typical duration for phase_1 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 29, 2016

Completed
Last Updated

June 15, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

September 21, 2012

Results QC Date

July 21, 2015

Last Update Submit

May 22, 2017

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Numeric Rating Scale (NRS) Pain Score With Movement

    Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)

    24 hours after the popliteal block is given

Secondary Outcomes (3)

  • Block Duration

    24 hours and 48 hours after the popliteal block is given

  • Numeric Rating Scale (NRS) Pain Score at Rest

    24 hours after the popliteal block is given

  • Median Time to Requiring Oral Opioids

    24 hours after the popliteal block is given

Study Arms (3)

Control NB + IV Dex + IV Bup

ACTIVE COMPARATOR

IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)

Drug: DexamethasoneDrug: Buprenorphine

Control NB + IV Dex

ACTIVE COMPARATOR

IV Dexamethasone (4 mg)

Drug: Dexamethasone

NB with Dex + Bup in block.

EXPERIMENTAL

Dexamethasone (4 mg) Buprenorphine (150 mcg)

Drug: DexamethasoneDrug: Buprenorphine

Interventions

DexamethasoneDRUG
Control NB + IV DexControl NB + IV Dex + IV BupNB with Dex + Bup in block.
BuprenorphineDRUG
Control NB + IV Dex + IV BupNB with Dex + Bup in block.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of Dr. Levine or Dr. Roberts at Hospital for Special Surgery
  • Patients aged 18-75
  • Patients scheduled for discharge from HSS after foot or ankle surgery
  • A single-injection popliteal fossa nerve block is judged appropriate

You may not qualify if:

  • \< 18 and \> 75
  • 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 (e.g. alleged bupivacaine sensitivity, low body weight, etc.)
  • Contraindications to dexamethasone or buprenorphine (e.g. allergy, insulin dependent diabetes mellitus, etc.)
  • Patients who have been diagnosed with altered pain perception or have lack of sensation
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital For Special Surgery

New York, New York, 10021, United States

Location

Related Publications (1)

  • YaDeau JT, Paroli L, Fields KG, Kahn RL, LaSala VR, Jules-Elysee KM, Kim DH, Haskins SC, Hedden J, Goon A, Roberts MM, Levine DS. Addition of Dexamethasone and Buprenorphine to Bupivacaine Sciatic Nerve Block: A Randomized Controlled Trial. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):321-9. doi: 10.1097/AAP.0000000000000254.

    PMID: 25974277DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

DexamethasoneBuprenorphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic Hydrocarbons

Results Point of Contact

Title
Dr. Jacques YaDeau
Organization
Hospital for Special Surgery
yadeauj@hss.edu
212-606-1206

Study Officials

  • Jacques YaDeau, MD, PhD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2012

First Posted

July 23, 2014

Study Start

October 1, 2012

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

June 15, 2017

Results First Posted

February 29, 2016

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)