CompletedNCT01277159Updated Apr 14, 2022Results posted

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

An interventional study of A. Control Nerve Block. IV Dexamethasone (4 mg). and B. Nerve Block with Dexamethasone (4 mg). IV saline. in Patients Undergoing Ankle Surgery, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-14.

Sponsored by Hospital for Special Surgery, New York · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 108
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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?

Conditions studied

Patients Undergoing Ankle Surgery

Keywords

Analgesia
Duration
Popliteal Fossa Nerve Block
Dexamethasone
Buprenorphine
Additives
Ankle surgery

In context

Lead sponsor

Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients of Dr Levine or Dr Roberts.
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).
Patients aged 18-75 years.

Exclusion criteria

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)

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 108 participants (actual)

Study arms

Experimental
Control Nerve Block. IV Dexamethasone (4 mg).
Control Nerve Block. IV Dexamethasone (4 mg).
Drug: 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.
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)
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).
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).

Interventions

DrugA. Control Nerve Block. IV Dexamethasone (4 mg).
A. Control Nerve Block. IV Dexamethasone (4 mg).
DrugB. Nerve Block with Dexamethasone (4 mg). IV saline.
B. Nerve Block with Dexamethasone (4 mg). IV saline.
DrugC. 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)
DrugD. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
DrugE. 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.

What researchers measure

Primary outcomes

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

Results

Posted Aug 31, 2017

Participant flow

Participant flow — Overall Study
Milestone	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
Started	21	22	22	22	21
Completed	17	21	19	19	16
Not completed	4	1	3	3	5

Outcome measures

PrimaryTime it Takes for Nerve Block to Wear Off

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

Time frame:: up to 72 hours
Reported as:: Mean · hours

Time it Takes for Nerve Block to Wear Off
hours	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
Time it Takes for Nerve Block to Wear Off	30.4 ± 5.1	45.1 ± 5.2	32.2 ± 6.1	45.6 ± 5.6	45.6 ± 5.8

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Control Nerve Block. IV Dexamethasone (4 mg).	—	0/17 (0%)	0/17 (0%)
Nerve Block With Dexamethasone (4 mg). IV Saline.	—	0/21 (0%)	0/21 (0%)
Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp	—	0/19 (0%)	0/19 (0%)
Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (	—	0/19 (0%)	0/19 (0%)
Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine	—	0/16 (0%)	0/16 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	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
Mean	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
Sex: Female, Male(Participants)	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
Female	11	13	10	14	13	61
Male	6	8	9	5	3	31

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	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
Count of participants	—	—	—	—	—	0

Study locations

1 site

Hospital for Special Surgery
New York, New York 10021, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01277159
Lead sponsor: Hospital for Special Surgery, New York
Responsible party: Sponsor
First posted: Jan 14, 2011
Start date: Oct 2010
Primary completion: Dec 2011
Completion: Dec 2011
Results posted: Aug 31, 2017
Last update: Apr 14, 2022

Study contacts

Michael Urban

principal investigator · Hospital for Special Surgery, New York

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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