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Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone

Buprenorphine

About this trial

This is an interventional other trial for Postoperative Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion)

Exclusion Criteria:

< 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)

Sites / Locations

Hospital For Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Control NB + IV Dex + IV Bup

Control NB + IV Dex

NB with Dex + Bup in block.

Arm Description

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

IV Dexamethasone (4 mg)

Dexamethasone (4 mg) Buprenorphine (150 mcg)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Block Duration

When did the nerve block entirely wear off?

Numeric Rating Scale (NRS) Pain Score at Rest

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

Median Time to Requiring Oral Opioids

Did patient have pain requiring oral opioids?

Full Information

NCT ID

NCT02198235

First Posted

September 21, 2012

Last Updated

May 22, 2017

Sponsor

Hospital for Special Surgery, New York

1. Study Identification

Unique Protocol Identification Number

NCT02198235

Brief Title

Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)

Official Title

Prolonged Popliteal Fossa Nerve Blockade

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital for Special Surgery, New York

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

Following major foot and ankle surgery patients complain of severe pain. Currently, Hospital for Special Surgery (HSS) usually uses nerve blocks (injections of local anesthetic near nerves supplying the lower leg) to help manage pain after this type of surgery. Patients also receive additional pain pills, including narcotics as needed. This study looks at addition of medications to the local anesthetic for the nerve blockade. The investigators hope that these medications (dexamethasone and buprenorphine) will prolong the pain relief from the nerve block. There are 3 groups in the study. One group is a control, and receives usual therapy: nerve block + pain pills. This is typically what the patient would receive as standard care if they were not in the study. One group uses a nerve block with additives (+ pain pills). One group gets a nerve block (local anesthetic only) + pain pills + intravenous buprenorphine - this is meant to see if the buprenorphine acts directly on the nerve that was blocked, or indirectly acts on the brain. Patients will be followed while in the hospital, and contacted by telephone and/or email after discharge for 2-3 days. Patients will be asked about their pain levels and the duration of their block. The investigators will enroll 90 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control NB + IV Dex + IV Bup

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control NB + IV Dex

Arm Type

Active Comparator

Arm Description

IV Dexamethasone (4 mg)

Arm Title

NB with Dex + Bup in block.

Arm Type

Experimental

Arm Description

Dexamethasone (4 mg) Buprenorphine (150 mcg)

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Type

Drug

Intervention Name(s)

Buprenorphine

Primary Outcome Measure Information:

Title

Numeric Rating Scale (NRS) Pain Score With Movement

Description

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

Time Frame

24 hours after the popliteal block is given

Secondary Outcome Measure Information:

Title

Block Duration

Description

When did the nerve block entirely wear off?

Time Frame

24 hours and 48 hours after the popliteal block is given

Title

Numeric Rating Scale (NRS) Pain Score at Rest

Description

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

Time Frame

24 hours after the popliteal block is given

Title

Median Time to Requiring Oral Opioids

Description

Did patient have pain requiring oral opioids?

Time Frame

24 hours after the popliteal block is given

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion) Exclusion Criteria: < 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacques YaDeau, MD, PhD

Organizational Affiliation

Hospital for Special Surgery, New York

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital For Special Surgery

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25974277

Citation

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.

Results Reference

derived

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Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)

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