Anesthesia, LocalPhase 4NCT03117140
Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block
A Phase 4 study testing Ropivacaine 0.75%, Ropivacaine 0.75% + 300 mcg Buprenorphine and Ropivacaine 0.75% + 75 mcg clonidine in people with Anesthesia, Local, run by Melinda Seering at 1 site in United States.
Trial summary
This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Ropivacaine 0.75%, Ropivacaine 0.75% + 300 mcg Buprenorphine and Ropivacaine 0.75% + 75 mcg clonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Mar 2017
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have or are:
- Orthopedics service patients having shoulder surgery
- ASA(American Society of Anesthesiologists) class I, II, or III.
- Patients at least 18 years old but less than 71 years old.
- Patients giving informed consent.
- Non-Emergency Surgery
Who cannot join
- Patients who have or are:
- An inability to cooperate during the block placement.
- Neuropathy of the planned extremity to block
- Diabetes
- Documented Kidney Disease
- Documented Liver Disease
Show all 9Show fewer
- A lack of or inability to give informed consent.
- Currently incarcerated.
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospital and Clinics, Ambulatory Surgery Clinic
Iowa City, Iowa, 52242
About this study
Official title: A Prospective Triple-masked Randomized Controlled Trial Measuring Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block
This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone.
Read the detailed description
This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone. This will be looked on on patients undergoing painful shoulder surgery in the ambulatory surgery center. Patients will be randomized to one of four groups (1. 0.75% plain ropivacaine. The reference comparator 2. A mixture of 0.75% ropivacaine with 300 mcg buprenorphine 3. A mixture of 0.75% ropivacaine with 75 mcg clonidine 4. A mixture of 0.75% ropivacaine with and 8mg dexamethasone) for their regimen in the interscalene block for their surgery. The patients will then be called within 3 days post-operatively to follow-up. Follow-up data collected will be when did the patient experience return of pain to the operative limb (duration of analgesia), when did the patient experience return of motor function of the operative limb (duration of motor block) and when did the patient experience return of sensation of the operative limb (return of sensory block). All three of these adjuvants have been studied previously and shown to have increased analgesic duration with local anesthesia, but have never had a good comparative study. The mechanism of action of the analgesia for these adjuvants pain relief has never been shown although it is likely a indirect effect as there are animal studies looking at their effect on A and C fibers that did not show those results.
- Conditions
- Anesthesia, Local
- Being tested
- Ropivacaine 0.75%, Ropivacaine 0.75% + 300 mcg Buprenorphine, Ropivacaine 0.75% + 75 mcg clonidine, Ropivacaine 0.75% + 8 mg dexamethasone
- Keywords
- Brachial Plexus Block, Clonidine, Dexamethasone, Buprenorphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.75%Drug
Also called Naropin
Only ropivacaine 0.75% is administered for this arm of the interscalene block
Ropivacaine 0.75% + 300 mcg BuprenorphineDrug
Also called Naropin + Buprenex
Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
Ropivacaine 0.75% + 75 mcg clonidineDrug
Also called Naropin + Duraclon
Ropivacaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block
Ropivacaine 0.75% + 8 mg dexamethasoneDrug
Also called Naropin + Decadron
Ropivacaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block
| Study group | Role | What they receive |
|---|---|---|
| Plain Ropivacaine | Active comparator | Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively Receives: Drug: Ropivacaine 0.75% |
| Ropivacaine + Buprenorphine | Experimental | A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively Receives: Drug: Ropivacaine 0.75% + 300 mcg Buprenorphine |
| Ropivacaine + Clonidine | Experimental | A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively Receives: Drug: Ropivacaine 0.75% + 75 mcg clonidine |
| Ropivaciane + Dexamethasone | Experimental | A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively Receives: Drug: Ropivacaine 0.75% + 8 mg dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Analgesia
Patients are called 1-3 days post-operatively to assess when the analgesia of their nerve block wore off
Measured: 1-3 days post-operative
Secondary outcomes (12)
Block Set up Time
Patients are assessed from needle removal to when they are no longer able to feel cold on the blocked extremity
Measured: Day one
Sensory Duration of Block
Patients are called 1-3 days post-operatively to assess when the sensory component of their nerve block wore off
Measured: Day 1-3
Patient Reporting Vomiting at Home
Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.
Measured: 1-3 days
Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit)
Vomiting in PACU (Post-Anesthesia Care Unit) for patients was looked at
Measured: Post-op Day 0 (Baseline)
Number of Patients Reporting Nausea at Home
Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.
Measured: 1-3 days
Number of Patients Reporting Nausea in the PACU
PACU (Post-Anesthesia Care Unit) assessment of nausea
Measured: Post-op day 0 (Baseline)
Motor Duration of Block
Patients are called 1-3 days post-operatively to assess when motor component of their nerve block wore off
Measured: Day 1-3
Number of Patients With Blood Pressure (BP) Changes in the PACU
Blood pressure changes in PACU (Post-Anesthesia Care Unit) for patients was looked at
Measured: Post-op Day 0 (baseline)
Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area
Blood pressure changes in Second Stage Recovery Area for patients was looked at
Measured: Post-op Day 0 (baseline)
Pain Score Reported by Patients at First Phone Call
Patients are called 1-3 days post-operatively to assess pain. Pain score is 0-10 scale with 0 is no pain and 10 is most severe pain.
Measured: Day 1-3
Number of Patients Reporting Itching in the PACU
Patients itching was assessed post-op in the PACU.
Measured: Post-op day 0 (baseline)
Number of Patients Reporting Itching at Home
Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.
Measured: 1-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study startDec 2013
- Primary completionMar 2017
- Study completionMar 2017
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 (33)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinda Seering
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melinda Seering, University of Iowa
- Investigators
- Melinda Seering, M.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117140
- Sponsor's protocol ID
- 201304727
- Status last verified
- Jul 2018
- First submitted
- 11 Apr 2017
- Last updated
- 3 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Brummett CM, Williams BA. Additives to local anesthetics for peripheral nerve blockade. Int Anesthesiol Clin. 2011 Fall;49(4):104-16. doi: 10.1097/AIA.0b013e31820e4a49.
PubMed 21956081Yilmaz-Rastoder E, Gold MS, Hough KA, Gebhart GF, Williams BA. Effect of adjuvant drugs on the action of local anesthetics in isolated rat sciatic nerves. Reg Anesth Pain Med. 2012 Jul-Aug;37(4):403-9. doi: 10.1097/AAP.0b013e3182485965.
PubMed 22430023Ilfeld BM, Morey TE, Enneking FK. Continuous infraclavicular brachial plexus block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. Anesthesiology. 2002 Jun;96(6):1297-304. doi: 10.1097/00000542-200206000-00006.
PubMed 12170039Ilfeld BM, Morey TE, Thannikary LJ, Wright TW, Enneking FK. Clonidine added to a continuous interscalene ropivacaine perineural infusion to improve postoperative analgesia: a randomized, double-blind, controlled study. Anesth Analg. 2005 Apr;100(4):1172-1178. doi: 10.1097/01.ASN.0000145571.41015.D5.
PubMed 15781540Ilfeld BM, Morey TE, Wang RD, Enneking FK. Continuous popliteal sciatic nerve block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. Anesthesiology. 2002 Oct;97(4):959-65. doi: 10.1097/00000542-200210000-00031.
PubMed 12357165Ilfeld BM, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Chmielewski TL, Spadoni EH, Wright TW. Ambulatory continuous interscalene nerve blocks decrease the time to discharge readiness after total shoulder arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2006 Nov;105(5):999-1007. doi: 10.1097/00000542-200611000-00022.
PubMed 17065895White PF, Issioui T, Skrivanek GD, Early JS, Wakefield C. The use of a continuous popliteal sciatic nerve block after surgery involving the foot and ankle: does it improve the quality of recovery? Anesth Analg. 2003 Nov;97(5):1303-1309. doi: 10.1213/01.ANE.0000082242.84015.D4.
PubMed 14570643Capdevila X, Pirat P, Bringuier S, Gaertner E, Singelyn F, Bernard N, Choquet O, Bouaziz H, Bonnet F; French Study Group on Continuous Peripheral Nerve Blocks. Continuous peripheral nerve blocks in hospital wards after orthopedic surgery: a multicenter prospective analysis of the quality of postoperative analgesia and complications in 1,416 patients. Anesthesiology. 2005 Nov;103(5):1035-45. doi: 10.1097/00000542-200511000-00018.
PubMed 16249678Saporito A, Sturini E, Petri J, Borgeat A, Aguirre JA. Case report: unusual complication during outpatient continuous regional popliteal analgesia. Can J Anaesth. 2012 Oct;59(10):958-62. doi: 10.1007/s12630-012-9758-9. Epub 2012 Jul 25.
PubMed 22829027Candido KD, Franco CD, Khan MA, Winnie AP, Raja DS. Buprenorphine added to the local anesthetic for brachial plexus block to provide postoperative analgesia in outpatients. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):352-6. doi: 10.1053/rapm.2001.23931.
PubMed 11464356Candido KD, Winnie AP, Ghaleb AH, Fattouh MW, Franco CD. Buprenorphine added to the local anesthetic for axillary brachial plexus block prolongs postoperative analgesia. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):162-7. doi: 10.1053/rapm.2002.30671.
PubMed 11915063Candido KD, Hennes J, Gonzalez S, Mikat-Stevens M, Pinzur M, Vasic V, Knezevic NN. Buprenorphine enhances and prolongs the postoperative analgesic effect of bupivacaine in patients receiving infragluteal sciatic nerve block. Anesthesiology. 2010 Dec;113(6):1419-26. doi: 10.1097/ALN.0b013e3181f90ce8.
PubMed 21042200Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.
PubMed 21676892Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.
PubMed 20009936Kim YJ, Lee GY, Kim DY, Kim CH, Baik HJ, Heo S. Dexamathasone added to levobupivacaine improves postoperative analgesia in ultrasound guided interscalene brachial plexus blockade for arthroscopic shoulder surgery. Korean J Anesthesiol. 2012 Feb;62(2):130-4. doi: 10.4097/kjae.2012.62.2.130. Epub 2012 Feb 20.
PubMed 22379567
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Triple-masked Randomized Controlled Trial Measuring Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block
- ClinicalTrials.gov ID
- NCT03117140
- Acronym / sponsor ID
- 201304727
- Conditions
- Anesthesia, Local
- Keywords
- Brachial Plexus Block, Clonidine, Dexamethasone, Buprenorphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Melinda SeeringUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Posted 3 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone.
Detailed description
This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone. This will be looked on on patients undergoing painful shoulder surgery in the ambulatory surgery center. Patients will be randomized to one of four groups (1. 0.75% plain ropivacaine. The reference comparator 2. A mixture of 0.75% ropivacaine with 300 mcg buprenorphine 3. A mixture of 0.75% ropivacaine with 75 mcg clonidine 4. A mixture of 0.75% ropivacaine with and 8mg dexamethasone) for their regimen in the interscalene block for their surgery. The patients will then be called within 3 days post-operatively to follow-up. Follow-up data collected will be when did the patient experience return of pain to the operative limb (duration of analgesia), when did the patient experience return of motor function of the operative limb (duration of motor block) and when did the patient experience return of sensation of the operative limb (return of sensory block). All three of these adjuvants have been studied previously and shown to have increased analgesic duration with local anesthesia, but have never had a good comparative study. The mechanism of action of the analgesia for these adjuvants pain relief has never been shown although it is likely a indirect effect as there are animal studies looking at their effect on A and C fibers that did not show those results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Plain Ropivacaine | Active comparator | Drug: Ropivacaine 0.75%Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively |
| Ropivacaine + Buprenorphine | Experimental | Drug: Ropivacaine 0.75% + 300 mcg BuprenorphineA mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively |
| Ropivacaine + Clonidine | Experimental | Drug: Ropivacaine 0.75% + 75 mcg clonidineA mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively |
| Ropivaciane + Dexamethasone | Experimental | Drug: Ropivacaine 0.75% + 8 mg dexamethasoneA mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who have or are:
Key exclusion criteria (9 listed)
- Patients who have or are:
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 |
|---|---|---|
| Ropivacaine 0.75%Also: NaropinOnly ropivacaine 0.75% is administered for this arm of the interscalene block | Drug | Plain Ropivacaine |
| Ropivacaine 0.75% + 300 mcg BuprenorphineAlso: Naropin + BuprenexRopivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block | Drug | Ropivacaine + Buprenorphine |
| Ropivacaine 0.75% + 75 mcg clonidineAlso: Naropin + DuraclonRopivacaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block | Drug | Ropivacaine + Clonidine |
| Ropivacaine 0.75% + 8 mg dexamethasoneAlso: Naropin + DecadronRopivacaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block | Drug | Ropivaciane + Dexamethasone |
Primary outcome
Duration of Analgesia
Time frame: 1-3 days post-operative
Patients are called 1-3 days post-operatively to assess when the analgesia of their nerve block wore off
12 secondary outcomes
Block Set up Time
Time frame: Day one
Sensory Duration of Block
Time frame: Day 1-3
Patient Reporting Vomiting at Home
Time frame: 1-3 days
Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit)
Time frame: Post-op Day 0 (Baseline)
Number of Patients Reporting Nausea at Home
Time frame: 1-3 days
Number of Patients Reporting Nausea in the PACU
Time frame: Post-op day 0 (Baseline)
Motor Duration of Block
Time frame: Day 1-3
Number of Patients With Blood Pressure (BP) Changes in the PACU
Time frame: Post-op Day 0 (baseline)
Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area
Time frame: Post-op Day 0 (baseline)
Pain Score Reported by Patients at First Phone Call
Time frame: Day 1-3
Number of Patients Reporting Itching in the PACU
Time frame: Post-op day 0 (baseline)
Number of Patients Reporting Itching at Home
Time frame: 1-3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21956081Brummett CM, Williams BA. Additives to local anesthetics for peripheral nerve blockade. Int Anesthesiol Clin. 2011 Fall;49(4):104-16. doi: 10.1097/AIA.0b013e31820e4a49.
- Background: PubMed 22430023Yilmaz-Rastoder E, Gold MS, Hough KA, Gebhart GF, Williams BA. Effect of adjuvant drugs on the action of local anesthetics in isolated rat sciatic nerves. Reg Anesth Pain Med. 2012 Jul-Aug;37(4):403-9. doi: 10.1097/AAP.0b013e3182485965.
- Background: PubMed 12170039Ilfeld BM, Morey TE, Enneking FK. Continuous infraclavicular brachial plexus block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. Anesthesiology. 2002 Jun;96(6):1297-304. doi: 10.1097/00000542-200206000-00006.
- Background: PubMed 15781540Ilfeld BM, Morey TE, Thannikary LJ, Wright TW, Enneking FK. Clonidine added to a continuous interscalene ropivacaine perineural infusion to improve postoperative analgesia: a randomized, double-blind, controlled study. Anesth Analg. 2005 Apr;100(4):1172-1178. doi: 10.1097/01.ASN.0000145571.41015.D5.
- Background: PubMed 12357165Ilfeld BM, Morey TE, Wang RD, Enneking FK. Continuous popliteal sciatic nerve block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. Anesthesiology. 2002 Oct;97(4):959-65. doi: 10.1097/00000542-200210000-00031.
- Background: PubMed 17065895Ilfeld BM, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Chmielewski TL, Spadoni EH, Wright TW. Ambulatory continuous interscalene nerve blocks decrease the time to discharge readiness after total shoulder arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2006 Nov;105(5):999-1007. doi: 10.1097/00000542-200611000-00022.
- Background: PubMed 14570643White PF, Issioui T, Skrivanek GD, Early JS, Wakefield C. The use of a continuous popliteal sciatic nerve block after surgery involving the foot and ankle: does it improve the quality of recovery? Anesth Analg. 2003 Nov;97(5):1303-1309. doi: 10.1213/01.ANE.0000082242.84015.D4.
- Background: PubMed 16249678Capdevila X, Pirat P, Bringuier S, Gaertner E, Singelyn F, Bernard N, Choquet O, Bouaziz H, Bonnet F; French Study Group on Continuous Peripheral Nerve Blocks. Continuous peripheral nerve blocks in hospital wards after orthopedic surgery: a multicenter prospective analysis of the quality of postoperative analgesia and complications in 1,416 patients. Anesthesiology. 2005 Nov;103(5):1035-45. doi: 10.1097/00000542-200511000-00018.
- Background: PubMed 22829027Saporito A, Sturini E, Petri J, Borgeat A, Aguirre JA. Case report: unusual complication during outpatient continuous regional popliteal analgesia. Can J Anaesth. 2012 Oct;59(10):958-62. doi: 10.1007/s12630-012-9758-9. Epub 2012 Jul 25.
- Background: PubMed 11464356Candido KD, Franco CD, Khan MA, Winnie AP, Raja DS. Buprenorphine added to the local anesthetic for brachial plexus block to provide postoperative analgesia in outpatients. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):352-6. doi: 10.1053/rapm.2001.23931.
- Background: PubMed 11915063Candido KD, Winnie AP, Ghaleb AH, Fattouh MW, Franco CD. Buprenorphine added to the local anesthetic for axillary brachial plexus block prolongs postoperative analgesia. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):162-7. doi: 10.1053/rapm.2002.30671.
- Background: PubMed 21042200Candido KD, Hennes J, Gonzalez S, Mikat-Stevens M, Pinzur M, Vasic V, Knezevic NN. Buprenorphine enhances and prolongs the postoperative analgesic effect of bupivacaine in patients receiving infragluteal sciatic nerve block. Anesthesiology. 2010 Dec;113(6):1419-26. doi: 10.1097/ALN.0b013e3181f90ce8.
- Individual participant dataSharing planned: Undecided
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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.
Melinda Seering, M.D. principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine 0.75%, Ropivacaine 0.75% + 300 mcg Buprenorphine and Ropivacaine 0.75% + 75 mcg clonidine in people with Anesthesia, Local, run by Melinda Seering 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 6 inclusion and 9 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 3 Jul 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 3 Jul 2018). 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?
Duration of Analgesia (time frame: 1-3 days post-operative). 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 NCT03117140, which also lists 33 linked publications.
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 3 Jul 2018.