Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)

Postoperative Pain Clinical Trial

Official title:

Prolonged Popliteal Fossa Nerve Blockade

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198235
• Other study ID #: 2012-017
• Status: Completed
• Phase: Phase 1
• First received: September 21, 2012
• Last updated: January 29, 2016
• Start date: October 2012
• Est. completion date: February 2014

Study information

• Verified date: July 2015
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexamethasone

• Buprenorphine

Locations

Country	Name	City	State
United States	Hospital For Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Block Duration	When did the nerve block entirely wear off?	24 hours and 48 hours after the popliteal block is given	No
Secondary	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	No
Secondary	Median Time to Requiring Oral Opioids	Did patient have pain requiring oral opioids?	24 hours after the popliteal block is given	No