Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT01277159
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Arms: 5
• Duration (Months): 14
• Patients Per Site Per Month: 7.7

Study Details

Study Description

Brief Summary

Patients scheduled to go home after ankle surgery at HSS typically receive a sciatic nerve block in the popliteal fossa and oral analgesic tablets (such as Percocet). Popliteal fossa nerve blockade has reduced pain for these patients (YaDeau et al, Anesth Analg 2008;106:1916-20), but unfortunately the patients still often experience moderate to severe pain after the block wears off. The investigators wish to study two additives that may prolong the period of analgesia provided by the nerve block. The additives will be studied in the context of a standardized postoperative multimodal analgesic pathway.

Primary outcome:

Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?

Condition or Disease	Intervention/Treatment	Phase
Patients Undergoing Ankle Surgery	Drug: A. Control Nerve Block. IV Dexamethasone (4 mg).; Drug: B. Nerve Block with Dexamethasone (4 mg). IV saline.; Drug: C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg); Drug: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).; Drug: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Control Nerve Block. IV Dexamethasone (4 mg). Control Nerve Block. IV Dexamethasone (4 mg).	Drug: A. Control Nerve Block. IV Dexamethasone (4 mg).; A. Control Nerve Block. IV Dexamethasone (4 mg).
Experimental: Nerve Block with Dexamethasone (4 mg). IV saline. B. Nerve Block with Dexamethasone (4 mg). IV saline.	Drug: B. Nerve Block with Dexamethasone (4 mg). IV saline.; B. Nerve Block with Dexamethasone (4 mg). IV saline.
Experimental: Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)	Drug: C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg); C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
Experimental: Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone ( Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).	Drug: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).; D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
Experimental: Nerve Block with Dexamethasone (4 mg) / block Buprenorphine Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.	Drug: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).; E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.

Outcome Measures

Primary Outcome Measures

1. Time it Takes for Nerve Block to Wear Off [up to 72 hours]

   Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Patients of Dr Levine or Dr Roberts.

2. Scheduled for discharge from HSS after foot or ankle surgery.

3. A single-injection popliteal fossa nerve block is judged appropriate.

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

5. Patients aged 18-75 years.

Exclusion Criteria:

• 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 with clonidine (e.g. alleged bupivacaine sensitivity, low body weight, clonidine allergy, etc.).

• Contraindications to dexamethasone or buprenorphine (e.g. allergy, Insulin Dependent Diabetes Mellitus, etc.)

• 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: Michael Urban, 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: NCT01277159
• Other Study ID Numbers: 2012-042
• First Posted: Jan 14, 2011
• Last Update Posted: Apr 14, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Hospital for Special Surgery, New York: Analgesia; Duration; Popliteal Fossa Nerve Block; Dexamethasone; Buprenorphine; Additives; Ankle surgery
• Additional relevant MeSH terms: Dexamethasone; Dexamethasone acetate; Buprenorphine; BB 1101

Study Results

Participant Flow

Arm/Group Title	Control Nerve Block. IV Dexamethasone (4 mg).	Nerve Block With Dexamethasone (4 mg). IV Saline.	Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp	Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (	Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine
Arm/Group Description	Control Nerve Block. IV Dexamethasone (4 mg). A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg).	B. Nerve Block with Dexamethasone (4 mg). IV saline. B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline.	Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)	Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).	Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline. E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
Period Title: Overall Study
STARTED	21	22	22	22	21
COMPLETED	17	21	19	19	16
NOT COMPLETED	4	1	3	3	5

Baseline Characteristics

Arm/Group Title	Control Nerve Block. IV Dexamethasone (4 mg).	Nerve Block With Dexamethasone (4 mg). IV Saline.	Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp	Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (	Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine	Total
Arm/Group Description	Control Nerve Block. IV Dexamethasone (4 mg). A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg).	B. Nerve Block with Dexamethasone (4 mg). IV saline. B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline.	Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)	Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).	Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline. E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.	Total of all reporting groups
Overall Participants	17	21	19	19	16	92
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.29 (6.8)	47.81 (9.5)	46.26 (7.5)	47.95 (8.6)	52.19 (7.2)	49.1 (8.6)
Sex: Female, Male (Count of Participants)
Female	11 64.7%	13 61.9%	10 52.6%	14 73.7%	13 81.3%	61 66.3%
Male	6 35.3%	8 38.1%	9 47.4%	5 26.3%	3 18.8%	31 33.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Time it Takes for Nerve Block to Wear Off
Description	Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?
Time Frame	up to 72 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Nerve Block. IV Dexamethasone (4 mg).	Nerve Block With Dexamethasone (4 mg). IV Saline.	Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp	Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (	Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine
Arm/Group Description	Control Nerve Block. IV Dexamethasone (4 mg). A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg).	B. Nerve Block with Dexamethasone (4 mg). IV saline. B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline.	Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)	Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).	Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline. E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
Measure Participants	17	21	19	19	16
Mean (Standard Deviation) [hours]	30.4 (5.1)	45.1 (5.2)	32.2 (6.1)	45.6 (5.6)	45.6 (5.8)

Adverse Events

Arm/Group Title	Control Nerve Block. IV Dexamethasone (4 mg).		Nerve Block With Dexamethasone (4 mg). IV Saline.		Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp		Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (		Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine
Arm/Group Description	Control Nerve Block. IV Dexamethasone (4 mg). A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg).		B. Nerve Block with Dexamethasone (4 mg). IV saline. B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline.		Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)		Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).		Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline. E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
All Cause Mortality
	Control Nerve Block. IV Dexamethasone (4 mg).		Nerve Block With Dexamethasone (4 mg). IV Saline.		Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp		Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (		Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Nerve Block. IV Dexamethasone (4 mg).		Nerve Block With Dexamethasone (4 mg). IV Saline.		Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp		Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (		Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/21 (0%)		0/19 (0%)		0/19 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Control Nerve Block. IV Dexamethasone (4 mg).		Nerve Block With Dexamethasone (4 mg). IV Saline.		Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp		Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (		Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/21 (0%)		0/19 (0%)		0/19 (0%)		0/16 (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.