Postoperative PainPhase 1NCT02198235
Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)
A Phase 1 study testing Dexamethasone and Buprenorphine in people with Postoperative Pain, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
This study looks at addition of medications to the local anesthetic for the nerve blockade. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexamethasone and Buprenorphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Feb 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- < 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.)
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital For Special Surgery
New York, New York, 10021
About this study
Official title: Prolonged Popliteal Fossa Nerve Blockade
This study looks at addition of medications to the local anesthetic for the nerve blockade.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Dexamethasone, Buprenorphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
BuprenorphineDrug
| Study group | Role | What they receive |
|---|---|---|
| Control NB + IV Dex + IV Bup | Active comparator | IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Receives: Drug: Dexamethasone; Drug: Buprenorphine |
| Control NB + IV Dex | Active comparator | IV Dexamethasone (4 mg) Receives: Drug: Dexamethasone |
| NB with Dex + Bup in block. | Experimental | Dexamethasone (4 mg) Buprenorphine (150 mcg) Receives: Drug: Dexamethasone; Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hours after the popliteal block is given
Secondary outcomes (3)
Block Duration
When did the nerve block entirely wear off?
Measured: 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)
Measured: 24 hours after the popliteal block is given
Median Time to Requiring Oral Opioids
Did patient have pain requiring oral opioids?
Measured: 24 hours after the popliteal block is given
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startOct 2012
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques YaDeau, MD, PhD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198235
- Sponsor's protocol ID
- 2012-017
- Status last verified
- May 2017
- First submitted
- 21 Sep 2012
- Last updated
- 15 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 25974277
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Popliteal Fossa Nerve Blockade
- ClinicalTrials.gov ID
- NCT02198235
- Acronym / sponsor ID
- 2012-017
- Conditions
- Postoperative Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Posted 29 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study looks at addition of medications to the local anesthetic for the nerve blockade.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control NB + IV Dex + IV Bup | Active comparator | Drug: Dexamethasone, Drug: BuprenorphineIV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) |
| Control NB + IV Dex | Active comparator | Drug: DexamethasoneIV Dexamethasone (4 mg) |
| NB with Dex + Bup in block. | Experimental | Drug: Dexamethasone, Drug: BuprenorphineDexamethasone (4 mg) Buprenorphine (150 mcg) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- < 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone | Drug | Control NB + IV Dex, Control NB + IV Dex + IV Bup, NB with Dex + Bup in block. |
| Buprenorphine | Drug | Control NB + IV Dex + IV Bup, NB with Dex + Bup in block. |
Primary outcome
Numeric Rating Scale (NRS) Pain Score With Movement
Time frame: 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)
3 secondary outcomes
Block Duration
Time frame: 24 hours and 48 hours after the popliteal block is given
Numeric Rating Scale (NRS) Pain Score at Rest
Time frame: 24 hours after the popliteal block is given
Median Time to Requiring Oral Opioids
Time frame: 24 hours after the popliteal block is given
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25974277YaDeau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques YaDeau, MD, PhD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone and Buprenorphine in people with Postoperative Pain, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) Pain Score With Movement (time frame: 24 hours after the popliteal block is given). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02198235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.