Atrial FibrillationPhase 4NCT03269383
Study to Evaluate the Effectiveness of SGB in Preventing Post-op Atrial Fibrillation
A Phase 4 study testing Bupivacaine and Saline in people with Atrial Fibrillation, run by Christopher Connors, MD at 1 site in United States.
Trial summary
Atrial fibrillation requires both an initiation trigger and favorable environment for maintenance and the sympathetic and parasympathetic nervous systems play important roles in this regard. Unfortunately, the precise mechanisms of post operative atrial fibrillation (POAF) are still being investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Bupivacaine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2019to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for non-emergent CABG, AVR, or CABG/AVR
- aged at least 18 years
- English speaking
Who cannot join
- aged less than 18 years
- pregnant women
- prisoners
- patients having emergency surgery
- patients with clinical contraindications to SGB (including allergy to local anesthetic, carotid vascular disease as defined by ipsilateral prior carotid endarterectomy or carotid stent, superficial infection at the proposed puncture site, contralateral phrenic or laryngeal nerve palsies, and severe chronic obstructive pulmonary disease as defined by the need for home oxygen)
- patients who are unable to provide informed consent for themselves
- patients with a history of atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study for the Evaluation of the Effectiveness of Stellate Ganglion Blockade in Preventing Postoperative Atrial Fibrillation
Atrial fibrillation requires both an initiation trigger and favorable environment for maintenance and the sympathetic and parasympathetic nervous systems play important roles in this regard. Unfortunately, the precise mechanisms of post operative atrial fibrillation (POAF) are still being investigated. This postoperative complication has persisted in spite of efforts to mitigate it pharmacologically with beta blockers and amiodarone, an experience shared by most other cardiac surgery centers.
The stellate ganglion is formed by the fusion of the inferior cervical sympathetic ganglion and first thoracic sympathetic ganglion. By modulating the sympathetic component of the autonomic nervous system, stellate ganglion stimulation has been shown to facilitate induction of atrial fibrillation while ablation may reduce or prevent episodes. Human studies have further supported this model.
Preliminary studies of perioperative stellate ganglion block (SGB) in cardiac surgery suggest that this technique may reduce or prevent episodes of POAF requiring treatment. The investigator's hypothesis is that SGB reduces the incidence of POAF in cardiac surgery populations.
Read the detailed description
The investigator's hypothesis is that perioperative SGB in cardiac surgery will decrease POAF. To address this, the investigator will:
- Recruit 707 patients to undergo perioperative SGB prior to cardiac surgery (CABG, Aortic Valve Replacement, CABG/Aortic Valve Replacement).
- Perform a double blinded post-induction/pre-operative SGB using either 10 mL 0.5% bupivacaine or 10 mL 0.9% normal saline
- Assess the effects on POAF as defined by the Northern New England (NNE) Cardiovascular Disease Study Group.
Significance: If the investigator is able to demonstrate that perioperative SGB in cardiac surgery affects POAF, this simple, low cost and low risk procedure may significantly impact POAF incidence and thereby its attendant morbidity, mortality and costs in this clinical population.
Study subjects 707 patients electively scheduled for aortic valve, coronary revascularization surgery (CABG) or a combination of the two (CABG/AVR) will be recruited and enrolled to receive SGB at the time of surgery. Patients will be introduced to the study by their surgical team and only those providing informed consent to participate will be enrolled. The informed consent document (attached) clearly states that SGB is not currently standard of care.
Randomization The investigator will use NQuery software (Statistical Solutions Ltd., Boston, MA) to create a randomization scheme stratified by the three types of elective surgery: CABG, aortic valve replacement, and CABG plus aortic valve replacement. Patients will be randomized in a 1:1 ratio to receive either SGB (case, injection of 10 mL 0.5% bupivacaine injection) or sham SGB (control, injection of 10 mL 0.9% saline). For each of the three surgery types, treatment assignments will be placed in opaque envelopes, numbered sequentially; these three series of assignments will be maintained in separate surgery-specific boxes. Medications will be unidentified at the time of injection and the anesthesiologists and cardiac surgeons will be blinded to sham versus treatment group.
Power analysis:
Sample size was calculated based on a group sequential test of two proportions (NQuery, Statistical Solutions Ltd., Boston, MA), which takes into account a single interim analysis of SGB efficacy once 50% of the proposed study group have been enrolled. At 80% power, cumulative alpha = 0.05, with a two-sided test with continuity correction, and using the O'Brien-Fleming spending function, a total study group of n=632 (n=316/ treatment group) would be required to detect a decrease in the rate post-operative atrial fibrillation from 30% to 20% with stellate ganglion block. After taking the interim analysis (performed when n=350; significance accepted at p<0.003) into account, significance will be accepted at p<0.047 for the overall study. In our preliminary feasibility study, the investigator established that stellate ganglion block was successful in 88% of cases; thus, the sample size was increased by 12%, from n=632 to n=707.
Data analysis. Descriptive statistics (mean (SD), median, frequency as appropriate) will be used to summarize the demographic, procedural and clinical characteristics of the study group. To evaluate the success of randomization, the investigator will describe demographic and clinical data both overall and after stratification by surgery type and by treatment type. As intra-operative conditions can direct modification in the actual surgery performed (e.g. CABG may become CABG plus valve replacement), the investigator will also describe the proportion of subjects who were misclassified by surgery type during randomization and if necessary will assess randomization balance according to the actual surgery type received.
The frequency of atrial fibrillation (AF) will be compared between treatment groups by chi square test; this primary analysis will be performed first using an intention to treat model. In post hoc analysis the investigator will explore treatment outcomes after stratification by type of surgery and established clinical risk factors for POAF (age, sex, smoking, obesity, hypertension, diabetes mellitus, myocardial infarction, and BMI). If descriptive analyses suggest imbalance in clinical or demographic characteristics between treatment groups, these will be explored using t tests or their non-parametric equivalent (continuous data) or chi square test (categorical data), as appropriate, and logistic regression will be used to evaluate differences in AF rate between treatment groups, while taking identified covariates into account.
- Conditions
- Atrial Fibrillation
- Being tested
- Bupivacaine, Saline
- Keywords
- stellate ganglion block, cardiac surgery, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called marcaine, Sensorcaine
Patients will receive a stellate ganglion block using 10 ml of 0.5% bupivacaine
SalineOther
Patients will receive a stellate ganglion block using 10 ml of 0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| Saline | Sham comparator | Patients will receive a stellate ganglion block but with 10ml of 0.9% saline. Receives: Other: Saline |
| Treatment | Experimental | Patients will receive a stellate ganglion block with 10ml of 0.5% bupivacaine Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative atrial fibrillation
looking for absence of new onset postoperative atrial fibrillation
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study startDec 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Lack of funding and other logistical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial with 2 arms, treatment and placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Connors, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher Connors, MD, MaineHealth
- Investigators
- Chris Connors, MD, Principal investigator, Spectrum Medical Group, Maine Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269383
- Sponsor's protocol ID
- 1046118-1
- Status last verified
- Apr 2019
- First submitted
- 19 Jun 2017
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mostafa A, El-Haddad MA, Shenoy M, Tuliani T. Atrial fibrillation post cardiac bypass surgery. Avicenna J Med. 2012 Jul;2(3):65-70. doi: 10.4103/2231-0770.102280.
PubMed 23826549Zhou Q, Hu J, Guo Y, Zhang F, Yang X, Zhang L, Xu X, Wang L, Wang H, Hou Y. Effect of the stellate ganglion on atrial fibrillation and atrial electrophysiological properties and its left-right asymmetry in a canine model. Exp Clin Cardiol. 2013 Winter;18(1):38-42.
PubMed 24294036Al-Atassi T, Toeg H, Malas T, Lam BK. Mapping and ablation of autonomic ganglia in prevention of postoperative atrial fibrillation in coronary surgery: MAAPPAFS atrial fibrillation randomized controlled pilot study. Can J Cardiol. 2014 Oct;30(10):1202-7. doi: 10.1016/j.cjca.2014.04.018. Epub 2014 Apr 19.
PubMed 25262862Yildirim V, Akay HT, Bingol H, Bolcal C, Iyem H, Doganci S, Demirkilic U, Tatar H. Pre-emptive stellate ganglion block increases the patency of radial artery grafts in coronary artery bypass surgery. Acta Anaesthesiol Scand. 2007 Apr;51(4):434-40. doi: 10.1111/j.1399-6576.2006.01260.x.
PubMed 17378781Bidwai AV, Rogers CR, Pearce M, Stanley TH. Preoperative stellate-ganglion blockade to prevent hypertension following coronary-artery operations. Anesthesiology. 1979 Oct;51(4):345-7. doi: 10.1097/00000542-197910000-00015. No abstract available.
PubMed 314762Donmez A, Tufan H, Tutar N, Araz C, Sezgin A, Karadeli E, Torgay A. In vivo and in vitro effects of stellate ganglion blockade on radial and internal mammary arteries. J Cardiothorac Vasc Anesth. 2005 Dec;19(6):729-33. doi: 10.1053/j.jvca.2004.10.008.
PubMed 16326296Garneau SY, Deschamps A, Couture P, Levesque S, Babin D, Lambert J, Tardif JC, Perrault LP, Denault AY. Preliminary experience in the use of preoperative echo-guided left stellate ganglion block in patients undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2011 Feb;25(1):78-84. doi: 10.1053/j.jvca.2010.03.007. Epub 2010 Jun 30.
PubMed 20580574Gopal D, Singh NG, Jagadeesh AM, Ture A, Thimmarayappa A. Comparison of left internal mammary artery diameter before and after left stellate ganglion block. Ann Card Anaesth. 2013 Oct-Dec;16(4):238-42. doi: 10.4103/0971-9784.119161.
PubMed 24107689Haest K, Kumar A, Van Calster B, Leunen K, Smeets A, Amant F, Berteloot P, Wildiers H, Paridaens R, Van Limbergen E, Weltens C, Janssen H, Peeters S, Menten J, Vergote I, Morlion B, Verhaeghe J, Christiaens MR, Neven P. Stellate ganglion block for the management of hot flashes and sleep disturbances in breast cancer survivors: an uncontrolled experimental study with 24 weeks of follow-up. Ann Oncol. 2012 Jun;23(6):1449-54. doi: 10.1093/annonc/mdr478. Epub 2011 Oct 29.
PubMed 22039079Kumar N, Thapa D, Gombar S, Ahuja V, Gupta R. Analgesic efficacy of pre-operative stellate ganglion block on postoperative pain relief: a randomised controlled trial. Anaesthesia. 2014 Sep;69(9):954-660. doi: 10.1111/anae.12774. Epub 2014 Jul 7.
PubMed 25040168Wulf H, Maier C. [Complications and side effects of stellate ganglion blockade. Results of a questionnaire survey]. Anaesthesist. 1992 Mar;41(3):146-51. German.
PubMed 1570888Stoller JK, Panos RJ, Krachman S, Doherty DE, Make B; Long-term Oxygen Treatment Trial Research Group. Oxygen therapy for patients with COPD: current evidence and the long-term oxygen treatment trial. Chest. 2010 Jul;138(1):179-87. doi: 10.1378/chest.09-2555.
PubMed 20605816
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Evaluation of the Effectiveness of Stellate Ganglion Blockade in Preventing Postoperative Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03269383
- Acronym / sponsor ID
- 1046118-1
- Conditions
- Atrial Fibrillation
- Keywords
- stellate ganglion block, cardiac surgery, atrial fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding and other logistical issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Christopher Connors, MDUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation requires both an initiation trigger and favorable environment for maintenance and the sympathetic and parasympathetic nervous systems play important roles in this regard. Unfortunately, the precise mechanisms of post operative atrial fibrillation (POAF) are still being investigated. This postoperative complication has persisted in spite of efforts to mitigate it pharmacologically with beta blockers and amiodarone, an experience shared by most other cardiac surgery centers.
The stellate ganglion is formed by the fusion of the inferior cervical sympathetic ganglion and first thoracic sympathetic ganglion. By modulating the sympathetic component of the autonomic nervous system, stellate ganglion stimulation has been shown to facilitate induction of atrial fibrillation while ablation may reduce or prevent episodes. Human studies have further supported this model.
Preliminary studies of perioperative stellate ganglion block (SGB) in cardiac surgery suggest that this technique may reduce or prevent episodes of POAF requiring treatment. The investigator's hypothesis is that SGB reduces the incidence of POAF in cardiac surgery populations.
Detailed description
The investigator's hypothesis is that perioperative SGB in cardiac surgery will decrease POAF. To address this, the investigator will:
- Recruit 707 patients to undergo perioperative SGB prior to cardiac surgery (CABG, Aortic Valve Replacement, CABG/Aortic Valve Replacement).
- Perform a double blinded post-induction/pre-operative SGB using either 10 mL 0.5% bupivacaine or 10 mL 0.9% normal saline
- Assess the effects on POAF as defined by the Northern New England (NNE) Cardiovascular Disease Study Group.
Significance: If the investigator is able to demonstrate that perioperative SGB in cardiac surgery affects POAF, this simple, low cost and low risk procedure may significantly impact POAF incidence and thereby its attendant morbidity, mortality and costs in this clinical population.
Study subjects 707 patients electively scheduled for aortic valve, coronary revascularization surgery (CABG) or a combination of the two (CABG/AVR) will be recruited and enrolled to receive SGB at the time of surgery. Patients will be introduced to the study by their surgical team and only those providing informed consent to participate will be enrolled. The informed consent document (attached) clearly states that SGB is not currently standard of care.
Randomization The investigator will use NQuery software (Statistical Solutions Ltd., Boston, MA) to create a randomization scheme stratified by the three types of elective surgery: CABG, aortic valve replacement, and CABG plus aortic valve replacement. Patients will be randomized in a 1:1 ratio to receive either SGB (case, injection of 10 mL 0.5% bupivacaine injection) or sham SGB (control, injection of 10 mL 0.9% saline). For each of the three surgery types, treatment assignments will be placed in opaque envelopes, numbered sequentially; these three series of assignments will be maintained in separate surgery-specific boxes. Medications will be unidentified at the time of injection and the anesthesiologists and cardiac surgeons will be blinded to sham versus treatment group.
Power analysis:
Sample size was calculated based on a group sequential test of two proportions (NQuery, Statistical Solutions Ltd., Boston, MA), which takes into account a single interim analysis of SGB efficacy once 50% of the proposed study group have been enrolled. At 80% power, cumulative alpha = 0.05, with a two-sided test with continuity correction, and using the O'Brien-Fleming spending function, a total study group of n=632 (n=316/ treatment group) would be required to detect a decrease in the rate post-operative atrial fibrillation from 30% to 20% with stellate ganglion block. After taking the interim analysis (performed when n=350; significance accepted at p<0.003) into account, significance will be accepted at p<0.047 for the overall study. In our preliminary feasibility study, the investigator established that stellate ganglion block was successful in 88% of cases; thus, the sample size was increased by 12%, from n=632 to n=707.
Data analysis. Descriptive statistics (mean (SD), median, frequency as appropriate) will be used to summarize the demographic, procedural and clinical characteristics of the study group. To evaluate the success of randomization, the investigator will describe demographic and clinical data both overall and after stratification by surgery type and by treatment type. As intra-operative conditions can direct modification in the actual surgery performed (e.g. CABG may become CABG plus valve replacement), the investigator will also describe the proportion of subjects who were misclassified by surgery type during randomization and if necessary will assess randomization balance according to the actual surgery type received.
The frequency of atrial fibrillation (AF) will be compared between treatment groups by chi square test; this primary analysis will be performed first using an intention to treat model. In post hoc analysis the investigator will explore treatment outcomes after stratification by type of surgery and established clinical risk factors for POAF (age, sex, smoking, obesity, hypertension, diabetes mellitus, myocardial infarction, and BMI). If descriptive analyses suggest imbalance in clinical or demographic characteristics between treatment groups, these will be explored using t tests or their non-parametric equivalent (continuous data) or chi square test (categorical data), as appropriate, and logistic regression will be used to evaluate differences in AF rate between treatment groups, while taking identified covariates into account.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial with 2 arms, treatment and placebo
| Arm | Type | Receives |
|---|---|---|
| Saline | Sham comparator | Other: SalinePatients will receive a stellate ganglion block but with 10ml of 0.9% saline. |
| Treatment | Experimental | Drug: BupivacainePatients will receive a stellate ganglion block with 10ml of 0.5% bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- scheduled for non-emergent CABG, AVR, or CABG/AVR
- aged at least 18 years
- English speaking
Key exclusion criteria (7 listed)
- aged less than 18 years
- pregnant women
- prisoners
- patients having emergency surgery
- patients with clinical contraindications to SGB (including allergy to local anesthetic, carotid vascular disease as defined by ipsilateral prior carotid endarterectomy or carotid stent, superficial infection at the proposed puncture site, contralateral phrenic or laryngeal nerve palsies, and severe chronic obstructive pulmonary disease as defined by the need for home oxygen)
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 |
|---|---|---|
| BupivacaineAlso: marcaine, SensorcainePatients will receive a stellate ganglion block using 10 ml of 0.5% bupivacaine | Drug | Treatment |
| SalinePatients will receive a stellate ganglion block using 10 ml of 0.9% saline | Other | Saline |
Primary outcome
Postoperative atrial fibrillation
Time frame: up to 7 days
looking for absence of new onset postoperative atrial fibrillation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Background: PubMed 23826549Mostafa A, El-Haddad MA, Shenoy M, Tuliani T. Atrial fibrillation post cardiac bypass surgery. Avicenna J Med. 2012 Jul;2(3):65-70. doi: 10.4103/2231-0770.102280.
- Background: PubMed 24294036Zhou Q, Hu J, Guo Y, Zhang F, Yang X, Zhang L, Xu X, Wang L, Wang H, Hou Y. Effect of the stellate ganglion on atrial fibrillation and atrial electrophysiological properties and its left-right asymmetry in a canine model. Exp Clin Cardiol. 2013 Winter;18(1):38-42.
- Background: PubMed 25262862Al-Atassi T, Toeg H, Malas T, Lam BK. Mapping and ablation of autonomic ganglia in prevention of postoperative atrial fibrillation in coronary surgery: MAAPPAFS atrial fibrillation randomized controlled pilot study. Can J Cardiol. 2014 Oct;30(10):1202-7. doi: 10.1016/j.cjca.2014.04.018. Epub 2014 Apr 19.
- Background: PubMed 17378781Yildirim V, Akay HT, Bingol H, Bolcal C, Iyem H, Doganci S, Demirkilic U, Tatar H. Pre-emptive stellate ganglion block increases the patency of radial artery grafts in coronary artery bypass surgery. Acta Anaesthesiol Scand. 2007 Apr;51(4):434-40. doi: 10.1111/j.1399-6576.2006.01260.x.
- Background: PubMed 314762Bidwai AV, Rogers CR, Pearce M, Stanley TH. Preoperative stellate-ganglion blockade to prevent hypertension following coronary-artery operations. Anesthesiology. 1979 Oct;51(4):345-7. doi: 10.1097/00000542-197910000-00015. No abstract available.
- Background: PubMed 16326296Donmez A, Tufan H, Tutar N, Araz C, Sezgin A, Karadeli E, Torgay A. In vivo and in vitro effects of stellate ganglion blockade on radial and internal mammary arteries. J Cardiothorac Vasc Anesth. 2005 Dec;19(6):729-33. doi: 10.1053/j.jvca.2004.10.008.
- Background: PubMed 20580574Garneau SY, Deschamps A, Couture P, Levesque S, Babin D, Lambert J, Tardif JC, Perrault LP, Denault AY. Preliminary experience in the use of preoperative echo-guided left stellate ganglion block in patients undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2011 Feb;25(1):78-84. doi: 10.1053/j.jvca.2010.03.007. Epub 2010 Jun 30.
- Background: PubMed 24107689Gopal D, Singh NG, Jagadeesh AM, Ture A, Thimmarayappa A. Comparison of left internal mammary artery diameter before and after left stellate ganglion block. Ann Card Anaesth. 2013 Oct-Dec;16(4):238-42. doi: 10.4103/0971-9784.119161.
- Background: PubMed 22039079Haest K, Kumar A, Van Calster B, Leunen K, Smeets A, Amant F, Berteloot P, Wildiers H, Paridaens R, Van Limbergen E, Weltens C, Janssen H, Peeters S, Menten J, Vergote I, Morlion B, Verhaeghe J, Christiaens MR, Neven P. Stellate ganglion block for the management of hot flashes and sleep disturbances in breast cancer survivors: an uncontrolled experimental study with 24 weeks of follow-up. Ann Oncol. 2012 Jun;23(6):1449-54. doi: 10.1093/annonc/mdr478. Epub 2011 Oct 29.
- Background: PubMed 25040168Kumar N, Thapa D, Gombar S, Ahuja V, Gupta R. Analgesic efficacy of pre-operative stellate ganglion block on postoperative pain relief: a randomised controlled trial. Anaesthesia. 2014 Sep;69(9):954-660. doi: 10.1111/anae.12774. Epub 2014 Jul 7.
- Background: PubMed 1570888Wulf H, Maier C. [Complications and side effects of stellate ganglion blockade. Results of a questionnaire survey]. Anaesthesist. 1992 Mar;41(3):146-51. German.
- Background: PubMed 20605816Stoller JK, Panos RJ, Krachman S, Doherty DE, Make B; Long-term Oxygen Treatment Trial Research Group. Oxygen therapy for patients with COPD: current evidence and the long-term oxygen treatment trial. Chest. 2010 Jul;138(1):179-87. doi: 10.1378/chest.09-2555.
- 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.
Chris Connors, MD principal investigator
Spectrum Medical Group, Maine Medical Center
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 Bupivacaine and Saline in people with Atrial Fibrillation, run by Christopher Connors, MD 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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 24 Apr 2019. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Postoperative atrial fibrillation (time frame: up to 7 days). 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 NCT03269383, which also lists 12 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 24 Apr 2019.