Pain, PostoperativePhase 2/3NCT05283980
Pectoral Nerve Blocks (PECs) for Cardiovascular Implantable Electronic Device Placement
A Phase 2/3 study testing 0.25% Bupivacaine in people with Pain, Postoperative and Pain, Acute, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether administration of a pectoral nerve blocks (Pecs I and II) with 0.25% bupivacaine are more effective as compared to placebo to provide analgesia for cardiac implantable electronic device (CIED) placement in cardiac electrophysiology lab Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Pain, Acute, Pain, Chest
- What is being tested?
- 0.25% Bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2022to 29 Mar 2024
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older
- Undergoing CIED placement in electrophysiology lab
- Booked with anesthesia service for the procedure.
Who cannot join
- Current participation in another interventional study
- Use of mechanical circulatory support device
- Emergent procedures
- Patients receiving other modalities of regional anesthesia like intrathecal morphine
- Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year)
- Current use of SSRI, TCA, anti-epileptics, gabapentin, or pregabalin as part of multimodal pain management
- Hypersensitivity to bupivacaine
- Hemodynamics related: Oxygenation outside of normal limits (defined as PaO2 < 60mmHg on an FiO2 of 1.0 or SpO2 < 85% within 30 minutes prior to drug administration), Received an infusion or bolus ≥ 0.05 mcg/kg/min of epinephrine o Received an infusion or bolus ≥ 0.50 mcg/kg/min of milrinone, Received an infusion or bolus ≥ 0.20 mcg/kg/min of norepinephrine o Significant clinician or nursing concern, Hemodynamically unstable (defined as HR > 120, SBP < 80, MAP < 50 within 30 minutes prior to drug administration)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pectoral Nerve Blocks (PECs) for Cardiovascular Implantable Electronic Device Placement: A Pilot Study
The purpose of this study is to determine whether administration of a pectoral nerve blocks (Pecs I and II) with 0.25% bupivacaine are more effective as compared to placebo to provide analgesia for cardiac implantable electronic device (CIED) placement in cardiac electrophysiology lab
Read the detailed description
Cardiovascular implantable electrical device (CIED) is a generalized term for pacemakers, implantable cardiac devices (ICDs) and cardiac resynchronization therapy (CRT) devices. CRT is a modality of cardiac pacing that provides simultaneous pacing of left ventricle (LV) and right ventricle (RV) as biventricular (BiV) pacing (CRT-pacemaker or CRT-P), or by a combined CRT-implantable-defibrillator (CRT-D). The indication for pacemaker implantation in a patient is abnormal cardiac electrical conduction such as sinus node dysfunction or high-grade atrioventricular block. CRT is indicated for patients with symptomatic heart failure with left bundle branch block. Patients undergoing CIEDs often have multiple other associated comorbidities such as pulmonary disease, chronic kidney disease etc. which places them at a high-risk for undergoing these procedures.
Every year, more than 500,000 CIEDs are implanted in the United States alone. These procedures are being done with increasing frequency in patients with arrhythmias, heart failure and other risk factors for sudden cardiac death. Opioid prescription usage and persistent use of opioids after CIED procedures remains very high. In the context of current opioid crisis, there is a growing need to find alternatives to optimize pain and limit opioid usage in the patient population.
The current standard practice for CIED placement is either under monitored anesthesia care (MAC) or general anesthesia. MAC is sedation and is usually performed using benzodiazepines, opioids, and propofol. Deleterious effects of opioids during sedation include respiratory or hemodynamic compromise, particularly in this high-risk patient population with low reserve. General anesthesia is invasive requiring endotracheal intubation and positive pressure ventilation, which can also compromise cardiorespiratory function. Finally, some patients with obesity or obstructive sleep apnea may have low tolerance to sedation and opioid use in procedures involving tunneling of leads or deeper chest wall tissue dissection. Despite procedural sedation or general anesthesia, patients generally continue to require pain medications postoperatively due to residual pain from the procedure.
Nerve blocks involve injection of local anesthetic around peripheral nerves or their branches to interrupt pain and other sensory signals thus alleviating pain. Pectoralis or Pecs block is one such nerve block and has recently been effectively in increasing evidence for various surgeries and procedures on chest wall. Few case reports in adult population undergoing pacemaker, ICD and CRT placement also emphasize the utility of these blocks especially in patients who are critically ill. Preliminary studies have shown lower sedation requirements and higher patient and proceduralist satisfaction with use of PEC block in these patients.
Moreover, there is no large study has evaluated the utility of PECs block in this patient population undergoing CIED insertion and there remains a need to investigate their utility in a systematic study.
There are two components to a Pecs block: Pecs I block that targets the lateral and medial pectoral nerves, suppliying both pectoral muscles (major and minor, and Pecs II block that targets the anterior and lateral division of the thoracic intercostal nerves T2-T6, the long thoracic nerve (C5-C7) which supplies the serratus anterior muscle and the thoracodorsal nerve (C6-C8) which innervates the latissimus dorsi muscle. Thus, combination of both Pecs I and II blocks can provide a widespread analgesic coverage and has been previously studied for analgesia for breast surgeries and also in thoracic trauma. It is a promising option considering its efficacy and ease of administration and may prove to be a useful analgesic technique in patients undergoing CIED insertion or replacement. The block is devoid of the systemic adverse events associated with opioids and hemodynamic complications associated with general anesthesia. It is a relatively superficial block and is therefore safe even on patient on antiplatelet therapy. It could prove useful in reducing intra-procedure analgesic requirement in the acute setting of postoperative pain as well as preventing chronic pain and has the potential to become the standard of care for analgesia in CIED procedures.
- Conditions
- Pain, Postoperative, Pain, Acute, Pain, Chest, Pain, Satisfaction, Patient, Opioid Use, Unspecified
- Being tested
- 0.25% Bupivacaine
- Medical subject headings
- Pain, Postoperative, Acute Pain, Chest Pain, Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25% BupivacaineDrug
The intervention group/ bupivacaine group will receive up to 25 ml of 0.25% bupivacaine hydrochloride for the Pecs block in comparison to the control group that would receive 0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine Group | Experimental | Receive up to 25 ml of 0.25% bupivacaine hydrochloride for the Pecs block Receives: Drug: 0.25% Bupivacaine |
| Control group | Placebo comparator | Receive up to 25 ml of normal 0.9% sodium chloride for the Pecs block Receives: Drug: 0.25% Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
peri-operative 24-hour consumption of opioids measured as OMEs (Opioid milliequivalents) in patients undergoing CIED procedures with and without Pecs blocks
Measured: 24 hours peri-procedure
Secondary outcomes (3)
Pain scores on a scale 1 - 10, 1 being the least pain and 10 being the worst pain
measure patient pain scores at 1 hour, 12 hours and 24hours after CIED procedure completion
Measured: at 1 hour, 12 hour and 24hours
Patient satisfaction scores
compare patient satisfaction scores at 24 hours between the two study groups and report the incidence of overall complications
Measured: at 24 hours post-procedure
Qualitative feedback from providers
Focus group discussion with electrophysiology providers, nursing providers and anesthesia providers will be conducted and qualitatively analyzed after completion of quantitative analysis.
The focus group discussions will be guided by quantitative results as well as patient feedback. This will be used to provide clinical context about utility and feasibility of the intervention from the provider standpoint.
Measured: Within three months of active enrollment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start17 Nov 2022
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is prospective, randomized, triple-blinded placebo-controlled study. Subjects will be randomize to undergo PECs block in the pre-procdure/ pre-operative area with either ).25% bupivacaine or 0.9% normal saline. They will then undergo the CIED placement in electrophysiology lab as current standard of care.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
- Investigators
- Sankalp Sehgal, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283980
- Sponsor's protocol ID
- 2021P001063
- Status last verified
- Jul 2026
- First submitted
- 8 Mar 2022
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Yang JK, Char DS, Motonaga KS, Navaratnam M, Dubin AM, Trela A, Hanisch DG, McFadyen G, Chubb H, Goodyer WR, Ceresnak SR. Pectoral nerve blocks decrease postoperative pain and opioid use after pacemaker or implantable cardioverter-defibrillator placement in children. Heart Rhythm. 2020 Aug;17(8):1346-1353. doi: 10.1016/j.hrthm.2020.03.009. Epub 2020 Mar 20.
PubMed 32201270Fujiwara A, Komasawa N, Minami T. Pectoral nerves (PECS) and intercostal nerve block for cardiac resynchronization therapy device implantation. Springerplus. 2014 Aug 5;3:409. doi: 10.1186/2193-1801-3-409. eCollection 2014.
PubMed 25120950Mavarez AC, Ripat CI, Suarez MR. Pectoralis Plane Block for Pacemaker Insertion: A Successful Primary Anesthetic. Front Surg. 2019 Nov 20;6:64. doi: 10.3389/fsurg.2019.00064. eCollection 2019.
PubMed 31824958Froyshteter AB, Bhalla T, Tobias JD, Cambier GS, Mckee CT. Pectoralis blocks for insertion of an implantable cardioverter defibrillator in two patients with Duchenne muscular dystrophy. Saudi J Anaesth. 2018 Apr-Jun;12(2):324-327. doi: 10.4103/sja.SJA_624_17.
PubMed 29628849Pai B H P, Shariat AN, Bhatt HV. PECS block for an ICD implantation in the super obese patient. J Clin Anesth. 2019 Nov;57:110-111. doi: 10.1016/j.jclinane.2019.04.003. Epub 2019 Apr 6. No abstract available.
PubMed 30965271Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
PubMed 21831090Hussain N, Brull R, McCartney CJL, Wong P, Kumar N, Essandoh M, Sawyer T, Sullivan T, Abdallah FW. Pectoralis-II Myofascial Block and Analgesia in Breast Cancer Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2019 Sep;131(3):630-648. doi: 10.1097/ALN.0000000000002822.
PubMed 31408448Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
PubMed 25376971Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.
PubMed 27543533
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pectoral Nerve Blocks (PECs) for Cardiovascular Implantable Electronic Device Placement: A Pilot Study
- ClinicalTrials.gov ID
- NCT05283980
- Acronym / sponsor ID
- 2021P001063
- Conditions
- Pain, Postoperative, Pain, Acute, Pain, Chest, Pain, Satisfaction, Patient, Opioid Use, Unspecified
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 17 Mar 2022 (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.
The purpose of this study is to determine whether administration of a pectoral nerve blocks (Pecs I and II) with 0.25% bupivacaine are more effective as compared to placebo to provide analgesia for cardiac implantable electronic device (CIED) placement in cardiac electrophysiology lab
Detailed description
Cardiovascular implantable electrical device (CIED) is a generalized term for pacemakers, implantable cardiac devices (ICDs) and cardiac resynchronization therapy (CRT) devices. CRT is a modality of cardiac pacing that provides simultaneous pacing of left ventricle (LV) and right ventricle (RV) as biventricular (BiV) pacing (CRT-pacemaker or CRT-P), or by a combined CRT-implantable-defibrillator (CRT-D). The indication for pacemaker implantation in a patient is abnormal cardiac electrical conduction such as sinus node dysfunction or high-grade atrioventricular block. CRT is indicated for patients with symptomatic heart failure with left bundle branch block. Patients undergoing CIEDs often have multiple other associated comorbidities such as pulmonary disease, chronic kidney disease etc. which places them at a high-risk for undergoing these procedures.
Every year, more than 500,000 CIEDs are implanted in the United States alone. These procedures are being done with increasing frequency in patients with arrhythmias, heart failure and other risk factors for sudden cardiac death. Opioid prescription usage and persistent use of opioids after CIED procedures remains very high. In the context of current opioid crisis, there is a growing need to find alternatives to optimize pain and limit opioid usage in the patient population.
The current standard practice for CIED placement is either under monitored anesthesia care (MAC) or general anesthesia. MAC is sedation and is usually performed using benzodiazepines, opioids, and propofol. Deleterious effects of opioids during sedation include respiratory or hemodynamic compromise, particularly in this high-risk patient population with low reserve. General anesthesia is invasive requiring endotracheal intubation and positive pressure ventilation, which can also compromise cardiorespiratory function. Finally, some patients with obesity or obstructive sleep apnea may have low tolerance to sedation and opioid use in procedures involving tunneling of leads or deeper chest wall tissue dissection. Despite procedural sedation or general anesthesia, patients generally continue to require pain medications postoperatively due to residual pain from the procedure.
Nerve blocks involve injection of local anesthetic around peripheral nerves or their branches to interrupt pain and other sensory signals thus alleviating pain. Pectoralis or Pecs block is one such nerve block and has recently been effectively in increasing evidence for various surgeries and procedures on chest wall. Few case reports in adult population undergoing pacemaker, ICD and CRT placement also emphasize the utility of these blocks especially in patients who are critically ill. Preliminary studies have shown lower sedation requirements and higher patient and proceduralist satisfaction with use of PEC block in these patients.
Moreover, there is no large study has evaluated the utility of PECs block in this patient population undergoing CIED insertion and there remains a need to investigate their utility in a systematic study.
There are two components to a Pecs block: Pecs I block that targets the lateral and medial pectoral nerves, suppliying both pectoral muscles (major and minor, and Pecs II block that targets the anterior and lateral division of the thoracic intercostal nerves T2-T6, the long thoracic nerve (C5-C7) which supplies the serratus anterior muscle and the thoracodorsal nerve (C6-C8) which innervates the latissimus dorsi muscle. Thus, combination of both Pecs I and II blocks can provide a widespread analgesic coverage and has been previously studied for analgesia for breast surgeries and also in thoracic trauma. It is a promising option considering its efficacy and ease of administration and may prove to be a useful analgesic technique in patients undergoing CIED insertion or replacement. The block is devoid of the systemic adverse events associated with opioids and hemodynamic complications associated with general anesthesia. It is a relatively superficial block and is therefore safe even on patient on antiplatelet therapy. It could prove useful in reducing intra-procedure analgesic requirement in the acute setting of postoperative pain as well as preventing chronic pain and has the potential to become the standard of care for analgesia in CIED procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is prospective, randomized, triple-blinded placebo-controlled study. Subjects will be randomize to undergo PECs block in the pre-procdure/ pre-operative area with either ).25% bupivacaine or 0.9% normal saline. They will then undergo the CIED placement in electrophysiology lab as current standard of care.
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine Group | Experimental | Drug: 0.25% BupivacaineReceive up to 25 ml of 0.25% bupivacaine hydrochloride for the Pecs block |
| Control group | Placebo comparator | Drug: 0.25% BupivacaineReceive up to 25 ml of normal 0.9% sodium chloride for the Pecs block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 years of age or older
- Undergoing CIED placement in electrophysiology lab
- Booked with anesthesia service for the procedure.
Key exclusion criteria (8 listed)
- Current participation in another interventional study
- Use of mechanical circulatory support device
- Emergent procedures
- Patients receiving other modalities of regional anesthesia like intrathecal morphine
- Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year)
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 |
|---|---|---|
| 0.25% BupivacaineThe intervention group/ bupivacaine group will receive up to 25 ml of 0.25% bupivacaine hydrochloride for the Pecs block in comparison to the control group that would receive 0.9% normal saline | Drug | Bupivacaine Group, Control group |
Primary outcome
Opioid consumption
Time frame: 24 hours peri-procedure
peri-operative 24-hour consumption of opioids measured as OMEs (Opioid milliequivalents) in patients undergoing CIED procedures with and without Pecs blocks
3 secondary outcomes
Pain scores on a scale 1 - 10, 1 being the least pain and 10 being the worst pain
Time frame: at 1 hour, 12 hour and 24hours
Patient satisfaction scores
Time frame: at 24 hours post-procedure
Qualitative feedback from providers
Time frame: Within three months of active enrollment completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 32201270Yang JK, Char DS, Motonaga KS, Navaratnam M, Dubin AM, Trela A, Hanisch DG, McFadyen G, Chubb H, Goodyer WR, Ceresnak SR. Pectoral nerve blocks decrease postoperative pain and opioid use after pacemaker or implantable cardioverter-defibrillator placement in children. Heart Rhythm. 2020 Aug;17(8):1346-1353. doi: 10.1016/j.hrthm.2020.03.009. Epub 2020 Mar 20.
- Background: PubMed 25120950Fujiwara A, Komasawa N, Minami T. Pectoral nerves (PECS) and intercostal nerve block for cardiac resynchronization therapy device implantation. Springerplus. 2014 Aug 5;3:409. doi: 10.1186/2193-1801-3-409. eCollection 2014.
- Background: PubMed 31824958Mavarez AC, Ripat CI, Suarez MR. Pectoralis Plane Block for Pacemaker Insertion: A Successful Primary Anesthetic. Front Surg. 2019 Nov 20;6:64. doi: 10.3389/fsurg.2019.00064. eCollection 2019.
- Background: PubMed 29628849Froyshteter AB, Bhalla T, Tobias JD, Cambier GS, Mckee CT. Pectoralis blocks for insertion of an implantable cardioverter defibrillator in two patients with Duchenne muscular dystrophy. Saudi J Anaesth. 2018 Apr-Jun;12(2):324-327. doi: 10.4103/sja.SJA_624_17.
- Background: PubMed 30965271Pai B H P, Shariat AN, Bhatt HV. PECS block for an ICD implantation in the super obese patient. J Clin Anesth. 2019 Nov;57:110-111. doi: 10.1016/j.jclinane.2019.04.003. Epub 2019 Apr 6. No abstract available.
- Background: PubMed 21831090Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
- Background: PubMed 31408448Hussain N, Brull R, McCartney CJL, Wong P, Kumar N, Essandoh M, Sawyer T, Sullivan T, Abdallah FW. Pectoralis-II Myofascial Block and Analgesia in Breast Cancer Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2019 Sep;131(3):630-648. doi: 10.1097/ALN.0000000000002822.
- Background: PubMed 25376971Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
- Background: PubMed 27543533Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.
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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.
Sankalp Sehgal, MD principal investigator
Beth Israel Deaconess 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 2/3 study testing 0.25% Bupivacaine in people with Pain, Postoperative and Pain, Acute, run by Beth Israel Deaconess Medical Center 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 8 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 30 Jul 2026. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Opioid consumption (time frame: 24 hours peri-procedure). 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 NCT05283980, which also lists 9 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 30 Jul 2026.