Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT02198235
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Duration (Months): 16
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Dexamethasone; Drug: Buprenorphine	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Prolonged Popliteal Fossa Nerve Blockade
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Numeric Rating Scale (NRS) Pain Score With Movement [24 hours after the popliteal block is given]

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

Secondary Outcome Measures

1. Block Duration [24 hours and 48 hours after the popliteal block is given]

   When did the nerve block entirely wear off?

2. Numeric Rating Scale (NRS) Pain Score at Rest [24 hours after the popliteal block is given]

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

3. Median Time to Requiring Oral Opioids [24 hours after the popliteal block is given]

   Did patient have pain requiring oral opioids?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital For Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

• Hospital for Special Surgery, New York

Investigators

• Principal Investigator: Jacques YaDeau, MD, PhD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT02198235
• Other Study ID Numbers: 2012-017
• First Posted: Jul 23, 2014
• Last Update Posted: Jun 15, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Pain, Postoperative; Dexamethasone; Buprenorphine

Study Results

Participant Flow

Arm/Group Title	Control Nerve Block + IV Dexamethasone	Control Nerve Block + IV Dexamethasone + IV Buprenorphine	Nerve Block With Dexamethasone + Buprenorphine in Block.
Arm/Group Description	IV Dexamethasone (4 mg) Dexamethasone	IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine	Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine
Period Title: Overall Study
STARTED	30	30	30
COMPLETED	27	28	28
NOT COMPLETED	3	2	2

Baseline Characteristics

Arm/Group Title	Control Nerve Block + IV Dexamethasone	Control Nerve Block + IV Dexamethasone + IV Buprenorphine	Nerve Block With Dexamethasone + Buprenorphine in Block.	Total
Arm/Group Description	IV Dexamethasone (4 mg) Dexamethasone	IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine	Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine	Total of all reporting groups
Overall Participants	30	30	30	90
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.2 (15.9)	51.1 (15.3)	52.8 (14.2)	51.7 (15)
Sex: Female, Male (Count of Participants)
Female	16 53.3%	18 60%	17 56.7%	51 56.7%
Male	14 46.7%	12 40%	13 43.3%	39 43.3%
Region of Enrollment (participants) [Number]
United States	30 100%	30 100%	30 100%	90 100%
BMI (Body Mass Index) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	27.2 (5.68)	26.3 (4.37)	26.3 (5.16)	26.6 (5.05)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Nerve Block + IV Dexamethasone	Control Nerve Block + IV Dexamethasone + IV Buprenorphine	Nerve Block With Dexamethasone + Buprenorphine in Block.
Arm/Group Description	IV Dexamethasone (4 mg) Dexamethasone	IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine	Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine
Measure Participants	27	28	28
Mean (Standard Deviation) [units on a scale]	1.9 (2.6)	1 (1.6)	1.3 (2.1)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Nerve Block + IV Dexamethasone	Control Nerve Block + IV Dexamethasone + IV Buprenorphine	Nerve Block With Dexamethasone + Buprenorphine in Block.
Arm/Group Description	IV Dexamethasone (4 mg) Dexamethasone	IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine	Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine
Measure Participants	27	28	28
Median (95% Confidence Interval) [hours]	30	37.9	45.6

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Nerve Block + IV Dexamethasone	Control Nerve Block + IV Dexamethasone + IV Buprenorphine	Nerve Block With Dexamethasone + Buprenorphine in Block.
Arm/Group Description	IV Dexamethasone (4 mg) Dexamethasone	IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine	Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine
Measure Participants	27	28	28
Mean (Standard Error) [units on a scale]	1.8 (2.5)	.9 (1.3)	.8 (1.6)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Nerve Block + IV Dexamethasone	Control Nerve Block + IV Dexamethasone + IV Buprenorphine	Nerve Block With Dexamethasone + Buprenorphine in Block.
Arm/Group Description	IV Dexamethasone (4 mg) Dexamethasone	IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine	Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine
Measure Participants	27	28	28
Median (95% Confidence Interval) [hours]	25.5	30	35.3

Adverse Events

Arm/Group Title	Control Nerve Block + IV Dexamethasone		Control Nerve Block + IV Dexamethasone + IV Buprenorphine		Nerve Block With Dexamethasone + Buprenorphine in Block.
Arm/Group Description	IV Dexamethasone (4 mg) Dexamethasone		IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine		Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine
All Cause Mortality
	Control Nerve Block + IV Dexamethasone		Control Nerve Block + IV Dexamethasone + IV Buprenorphine		Nerve Block With Dexamethasone + Buprenorphine in Block.
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Nerve Block + IV Dexamethasone		Control Nerve Block + IV Dexamethasone + IV Buprenorphine		Nerve Block With Dexamethasone + Buprenorphine in Block.
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Control Nerve Block + IV Dexamethasone		Control Nerve Block + IV Dexamethasone + IV Buprenorphine		Nerve Block With Dexamethasone + Buprenorphine in Block.
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.