Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)

Prolonged Popliteal Fossa Nerve Blockade

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Dexamethasone; Drug: Buprenorphine

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control NB + IV Dex + IV Bup; IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)	Drug: Dexamethasone; Drug: Buprenorphine
Active Comparator: Control NB + IV Dex; IV Dexamethasone (4 mg)	Drug: Dexamethasone
Experimental: NB with Dex + Bup in block.; Dexamethasone (4 mg) Buprenorphine (150 mcg)	Drug: Dexamethasone; Drug: Buprenorphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Block Duration	When did the nerve block entirely wear off?	24 hours and 48 hours after the popliteal block is given
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)	24 hours after the popliteal block is given
Median Time to Requiring Oral Opioids	Did patient have pain requiring oral opioids?	24 hours after the popliteal block is given

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: September 21, 2012
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (Estimate): July 23, 2014

Study Record Updates

• Last Update Posted (Actual): June 15, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Dexamethasone; Buprenorphine
• Other Study ID Numbers: 2012-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO