Post-operative PainPhase 4SPIFFYNCT05146453
Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology
A Phase 4 study testing Pectointercostal fascia blocks in people with Post-operative Pain, run by University of Alberta at 1 site in Canada.
Trial summary
This study is looking to see if a regional block placed on each side of the incision after surgery helps with pain relief. Ultrasound-guided pectointercostal fascia blocks will be placed at the conclusion of surgery following application of dressings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Pectointercostal fascia blocks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 22 Sep 2022to 11 Jun 2023
- 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
- adult patients presenting to the Mazankowski Heart Institute for operations via full midline sternotomy, i.e.: coronary artery bypass grafting, and/or single valve repair or single valve replacement who are expected to be fast track candidates post-operatively.
- patients scheduled for cardiac bypass grafting and/or single valve surgery requiring cardiopulmonary bypass.
Who cannot join
- Unstable or fluctuating cardiac condition (acute MI, HF, tamponade, type A dissection, ongoing refractory arrhythmia, LVEF <40%, massive transfusion protocol, reinstitution of CPB or other mechanical support)
- Alternative surgical approach (e.g. thoracotomy, mini sternotomy)
- Repeat sternotomy or emergency surgery
- Pregnancy or lactation
- Age <18
- Chronic pain
Show all 11Show fewer
- Tolerance to opioids
- Active alcohol misuse disorder, IVDU or cannabis use >1g/d
- Allergy to local anesthetics
- Inability to provide informed consent
- High doses of steroids pre-operatively (>10 mg prednisone/day)
Trial locations and contacts
1 site in 1 country.
About this study
This study is looking to see if a regional block placed on each side of the incision after surgery helps with pain relief. Ultrasound-guided pectointercostal fascia blocks will be placed at the conclusion of surgery following application of dressings. Patients will be in the supine position with the surgical drapes in place. The blocks are performed using a high frequency linear transducer with aseptic technique. The investigators hypothesize that placement of PIF blocks and catheters will decrease acute postoperative pain from midline sternotomy in fast track cardiac surgery patients compared to the current standard of care.
A physician will place an ultrasound guided pecto-intercostal fascial plane blocks bilaterally at the conclusion of surgery. They will also leave a catheter, similar to a small IV, between the muscle layers where the freezing medication goes. This will let the investigators give more freezing medication over the first 24 hours after surgery. The freezing medication blocks the pain signals from travelling to your brain from your incision, which might help participants need fewer narcotics after surgery.
Read more
Some of the research on this block shows a trend toward reduced pain, but the use of a catheter to allow repeat doses of freezing medication has not been studied. The investigators hope to show that this regional block means participants need less opioids (narcotics) in the first 2 days after their heart surgery.
In order to see whether the regional block is helpful there will be two groups of study participants. Both groups will receive infusion catheters covered with opaque bandages however one group will receive the study drug (ropivacaine) and the other will not (placebo). To reduce the risks to placebo group participants, those participants will have a catheter taped to their skin surface under an opaque dressing. This will give the illusion of block placement without the risks of a needle poking through skin. Both groups will still be given pain medications by IV or by mouth as needed after the surgery.
Read the detailed description
Acute postoperative pain at median sternotomy sites is common in cardiac surgery patients. Inadequate control of acute pain can lead to sympathetic activation, hemodynamic sequelae, respiratory compromise, delirium and contributes to the development of chronic pain. Parental opioids have long been at the forefront of perioperative pain management for cardiac surgery patients, historically in large intravenous doses. With the onset of fast-track cardiac anesthesia (FTCA) which emphasizes reduced periods of post-operative mechanical ventilation, intensive care unit stay and overall health care cost; new strategies for managing post-operative pain in cardiac surgery patients are required. Opioid focused strategies contribute to many side effects including sedation, confusion, apnea, nausea, emesis, and ileusF , which can prevent effective fast tracking of these patients.
FTCA has highlighted the potential for regional anesthetic techniques to revolutionize post-operative cardiac surgery care. Though thoracic epidural analgesia offers excellent analgesia for post-sternotomy pain, the small but catastrophic risk of epidural hematoma in heparinized patients has hindered it from becoming standard of care. Over the last decade, various thoracic wall blocks have been developed and shown to benefit patients presenting for thoracic or breast surgeries, and sternotomies. Of these, fascial plane thoracic wall blocks offer the advantages of being simple to perform ultrasound equipment and having low complications rates.
One such block is the pectointercostal fascia (PIF) block which was first described in 2014 as an analgesic adjunct for breast procedures. In this block the fascial plane between the pectoralis major and internal intercostal muscles is infiltrated with local anesthetic with the aim of anesthetizing the anterior cutaneous branches of the intercostal nerves, thereby providing analgesia to the anterior chest wall from T2 to T6 with a single injection. The block can be placed with ultrasound guidance with the patient in the supine position - making it easy to place in the operating room or as a rescue block in CVICU. Despite the higher volumes of local anesthetic required for a plane block of this nature, previous studies have shown that the serum levels of local anesthetic remain well below the toxic rangeI,J. Injection into the fascial plane allows for excellent spread of local anesthetic along multiple rib spaces, precluding the need for multiple injections. It also opens up a space for placement of a catheter thus providing the option of longer term analgesia in postoperative patients. While PIF blocks avoid the hemodynamic side effects and risk of neuraxial complications associated with thoracic epidurals and paravertebral catheters they are not without risk. These risks include potential hemothorax, pneumothorax, chest wall hematoma, local anesthetic systemic toxicity and surgical site infection.
- Conditions
- Post-operative Pain
- Being tested
- Pectointercostal fascia blocks, Placebo
- Keywords
- sternotomy, regional anesthesia, pectointercoastal fascia block, fast-track cardiac surgery, post-operative pain, truncal nerve block, cardiac surgery, cardiac anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectointercostal fascia blocksProcedure or surgery
Also called peripheral nerve block, regional anesthesia
PIF blocks will be placed at the conclusion of surgery with the surgical drapes in place. The blocks are performed using a high frequency linear transducer with aseptic technique. The ultrasound probe is placed longitudinally 3 cm from the sternum at the level of the 4th-6th intercostal space. Using an in-plane approach, an echogenic needle will be advanced into the fascial plane between pectoralis major and the external intercostal muscles. Peripheral nerve block catheters will then be inserted and secured to the skin surface with tegaderm. For patients weighing over 70 kg, 20 mL of 0.5% ropivacaine will be administered. This will be reduced to 15mL per side for patients weighing less than 70 kg. A CADD™ pump will be connected to each catheter and programmed to deliver 20 mL boluses of ropivacaine 0.2% starting at postoperative hour 2. The boluses will be staggered every 2 hours on alternate sides until hour 24. The catheters will be removed 24 hours post-operatively.
PlaceboOther
The control group patients will receive the same intraoperative analgesia management. A PIF block will not be performed, instead, a peripheral nerve block catheter will be secured to the skin surface and connected to a CADD™ pump. As the catheter is taped to the skin surface the control group patients will not be exposed to the risks of peripheral nerve block placement.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This group of patients will undergo placement of US guided pectointercostal fascia blocks. Receives: Procedure: Pectointercostal fascia blocks |
| Placebo | Placebo comparator | The control group patients will receive the same intraoperative analgesia management. A PIF block will not be performed, instead, a peripheral nerve block catheter will be secured to the skin surface and connected to a CADD™ pump. As the catheter is taped to the skin surface the control group patients will not be exposed to the risks of peripheral nerve block placement. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Cumulative opioid consumption in milligrams of morphine in the first 12 hours after surgery.
Measured: 12 hours
Secondary outcomes (6)
Opioid consumption in 24 hours
Amount of opioid consumed in 24 hours
Measured: 24 hours post-operatively
Time to extubation
Time until ETT is removed post-operatively.
Measured: 24 hours
Pain score
Pain score as reported using the numeric rating scale
Measured: Every 6 hours for 24 hours post-operatively
ICU length of stay
Length of stay in ICU
Measured: 2 weeks
Surgical site infection rate
Until hospital discharge
Measured: 4 weeks
Local anesthetic systemic toxicity effects
As evidenced by: tinnitus, perioral numbness, metallic taste
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start22 Sep 2022
- Primary completion11 Jun 2023
- Study completion11 Jun 2023
Why it stopped: Study published by different group; this study would not add to the existing knowledge.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wing Lam, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146453
- Sponsor's protocol ID
- Pro00114968
- Acronym
- SPIFFY
- Status last verified
- Dec 2023
- First submitted
- 22 Nov 2021
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kelava M, Alfirevic A, Bustamante S, Hargrave J, Marciniak D. Regional Anesthesia in Cardiac Surgery: An Overview of Fascial Plane Chest Wall Blocks. Anesth Analg. 2020 Jul;131(1):127-135. doi: 10.1213/ANE.0000000000004682.
PubMed 32032103Fujii S, Bairagi R, Roche M, Zhou JR. Transversus Thoracis Muscle Plane Block. Biomed Res Int. 2019 Jul 7;2019:1716365. doi: 10.1155/2019/1716365. eCollection 2019.
PubMed 31360703Lloyd-Donald P, Lee WS, Hooper JW, Lee DK, Moore A, Chandra N, McCall P, Seevanayagam S, Matalanis G, Warrillow S, Weinberg L. Fast-track recovery program after cardiac surgery in a teaching hospital: a quality improvement initiative. BMC Res Notes. 2021 May 22;14(1):201. doi: 10.1186/s13104-021-05620-w.
PubMed 34022969Kar P, Ramachandran G. Pain relief following sternotomy in conventional cardiac surgery: A review of non neuraxial regional nerve blocks. Ann Card Anaesth. 2020 Apr-Jun;23(2):200-208. doi: 10.4103/aca.ACA_241_18.
PubMed 32275036de la Torre PA, Garcia PD, Alvarez SL, Miguel FJ, Perez MF. A novel ultrasound-guided block: a promising alternative for breast analgesia. Aesthet Surg J. 2014 Jan 1;34(1):198-200. doi: 10.1177/1090820X13515902. No abstract available.
PubMed 24396082McDonald SB, Jacobsohn E, Kopacz DJ, Desphande S, Helman JD, Salinas F, Hall RA. Parasternal block and local anesthetic infiltration with levobupivacaine after cardiac surgery with desflurane: the effect on postoperative pain, pulmonary function, and tracheal extubation times. Anesth Analg. 2005 Jan;100(1):25-32. doi: 10.1213/01.ANE.0000139652.84897.BD.
PubMed 15616047Nasr DA, Abdelhamid HM, Mohsen M, Aly AH. The analgesic efficacy of continuous presternal bupivacaine infusion through a single catheter after cardiac surgery. Ann Card Anaesth. 2015 Jan-Mar;18(1):15-20. doi: 10.4103/0971-9784.148314.
PubMed 25566704Lee CY, Robinson DA, Johnson CA Jr, Zhang Y, Wong J, Joshi DJ, Wu TT, Knight PA. A Randomized Controlled Trial of Liposomal Bupivacaine Parasternal Intercostal Block for Sternotomy. Ann Thorac Surg. 2019 Jan;107(1):128-134. doi: 10.1016/j.athoracsur.2018.06.081. Epub 2018 Aug 28.
PubMed 30170012Chin KJ, Versyck B, Pawa A. Ultrasound-guided fascial plane blocks of the chest wall: a state-of-the-art review. Anaesthesia. 2021 Jan;76 Suppl 1:110-126. doi: 10.1111/anae.15276.
PubMed 33426660Nielsen S, Degenhardt L, Hoban B, Gisev N. A synthesis of oral morphine equivalents (OME) for opioid utilisation studies. Pharmacoepidemiol Drug Saf. 2016 Jun;25(6):733-7. doi: 10.1002/pds.3945. Epub 2015 Dec 22.
PubMed 26693665
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology
- ClinicalTrials.gov ID
- NCT05146453
- Acronym / sponsor ID
- SPIFFY / Pro00114968
- Conditions
- Post-operative Pain
- Keywords
- sternotomy, regional anesthesia, pectointercoastal fascia block, fast-track cardiac surgery, post-operative pain, truncal nerve block, cardiac surgery, cardiac anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study published by different group; this study would not add to the existing knowledge.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 11 Jun 2023 (actual)
- Study completion
- 11 Jun 2023 (actual)
- First posted
- 6 Dec 2021 (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.
This study is looking to see if a regional block placed on each side of the incision after surgery helps with pain relief. Ultrasound-guided pectointercostal fascia blocks will be placed at the conclusion of surgery following application of dressings. Patients will be in the supine position with the surgical drapes in place. The blocks are performed using a high frequency linear transducer with aseptic technique. The investigators hypothesize that placement of PIF blocks and catheters will decrease acute postoperative pain from midline sternotomy in fast track cardiac surgery patients compared to the current standard of care.
A physician will place an ultrasound guided pecto-intercostal fascial plane blocks bilaterally at the conclusion of surgery. They will also leave a catheter, similar to a small IV, between the muscle layers where the freezing medication goes. This will let the investigators give more freezing medication over the first 24 hours after surgery. The freezing medication blocks the pain signals from travelling to your brain from your incision, which might help participants need fewer narcotics after surgery.
Some of the research on this block shows a trend toward reduced pain, but the use of a catheter to allow repeat doses of freezing medication has not been studied. The investigators hope to show that this regional block means participants need less opioids (narcotics) in the first 2 days after their heart surgery.
In order to see whether the regional block is helpful there will be two groups of study participants. Both groups will receive infusion catheters covered with opaque bandages however one group will receive the study drug (ropivacaine) and the other will not (placebo). To reduce the risks to placebo group participants, those participants will have a catheter taped to their skin surface under an opaque dressing. This will give the illusion of block placement without the risks of a needle poking through skin. Both groups will still be given pain medications by IV or by mouth as needed after the surgery.
Detailed description
Acute postoperative pain at median sternotomy sites is common in cardiac surgery patients. Inadequate control of acute pain can lead to sympathetic activation, hemodynamic sequelae, respiratory compromise, delirium and contributes to the development of chronic pain. Parental opioids have long been at the forefront of perioperative pain management for cardiac surgery patients, historically in large intravenous doses. With the onset of fast-track cardiac anesthesia (FTCA) which emphasizes reduced periods of post-operative mechanical ventilation, intensive care unit stay and overall health care cost; new strategies for managing post-operative pain in cardiac surgery patients are required. Opioid focused strategies contribute to many side effects including sedation, confusion, apnea, nausea, emesis, and ileusF , which can prevent effective fast tracking of these patients.
FTCA has highlighted the potential for regional anesthetic techniques to revolutionize post-operative cardiac surgery care. Though thoracic epidural analgesia offers excellent analgesia for post-sternotomy pain, the small but catastrophic risk of epidural hematoma in heparinized patients has hindered it from becoming standard of care. Over the last decade, various thoracic wall blocks have been developed and shown to benefit patients presenting for thoracic or breast surgeries, and sternotomies. Of these, fascial plane thoracic wall blocks offer the advantages of being simple to perform ultrasound equipment and having low complications rates.
One such block is the pectointercostal fascia (PIF) block which was first described in 2014 as an analgesic adjunct for breast procedures. In this block the fascial plane between the pectoralis major and internal intercostal muscles is infiltrated with local anesthetic with the aim of anesthetizing the anterior cutaneous branches of the intercostal nerves, thereby providing analgesia to the anterior chest wall from T2 to T6 with a single injection. The block can be placed with ultrasound guidance with the patient in the supine position - making it easy to place in the operating room or as a rescue block in CVICU. Despite the higher volumes of local anesthetic required for a plane block of this nature, previous studies have shown that the serum levels of local anesthetic remain well below the toxic rangeI,J. Injection into the fascial plane allows for excellent spread of local anesthetic along multiple rib spaces, precluding the need for multiple injections. It also opens up a space for placement of a catheter thus providing the option of longer term analgesia in postoperative patients. While PIF blocks avoid the hemodynamic side effects and risk of neuraxial complications associated with thoracic epidurals and paravertebral catheters they are not without risk. These risks include potential hemothorax, pneumothorax, chest wall hematoma, local anesthetic systemic toxicity and surgical site infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Pectointercostal fascia blocksThis group of patients will undergo placement of US guided pectointercostal fascia blocks. |
| Placebo | Placebo comparator | Other: PlaceboThe control group patients will receive the same intraoperative analgesia management. A PIF block will not be performed, instead, a peripheral nerve block catheter will be secured to the skin surface and connected to a CADD™ pump. As the catheter is taped to the skin surface the control group patients will not be exposed to the risks of peripheral nerve block placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients presenting to the Mazankowski Heart Institute for operations via full midline sternotomy, i.e.: coronary artery bypass grafting, and/or single valve repair or single valve replacement who are expected to be fast track candidates post-operatively.
- patients scheduled for cardiac bypass grafting and/or single valve surgery requiring cardiopulmonary bypass.
Key exclusion criteria (11 listed)
- Unstable or fluctuating cardiac condition (acute MI, HF, tamponade, type A dissection, ongoing refractory arrhythmia, LVEF <40%, massive transfusion protocol, reinstitution of CPB or other mechanical support)
- Alternative surgical approach (e.g. thoracotomy, mini sternotomy)
- Repeat sternotomy or emergency surgery
- Pregnancy or lactation
- Age <18
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 |
|---|---|---|
| Pectointercostal fascia blocksAlso: peripheral nerve block, regional anesthesiaPIF blocks will be placed at the conclusion of surgery with the surgical drapes in place. The blocks are performed using a high frequency linear transducer with aseptic technique. The ultrasound probe is placed longitudinally 3 cm from the sternum at the level of the 4th-6th intercostal space. Using an in-plane approach, an echogenic needle will be advanced into the fascial plane between pectoralis major and the external intercostal muscles. Peripheral nerve block catheters will then be inserted and secured to the skin surface with tegaderm. For patients weighing over 70 kg, 20 mL of 0.5% ropivacaine will be administered. This will be reduced to 15mL per side for patients weighing less than 70 kg. A CADD™ pump will be connected to each catheter and programmed to deliver 20 mL boluses of ropivacaine 0.2% starting at postoperative hour 2. The boluses will be staggered every 2 hours on alternate sides until hour 24. The catheters will be removed 24 hours post-operatively. | Procedure or surgery | Intervention |
| PlaceboThe control group patients will receive the same intraoperative analgesia management. A PIF block will not be performed, instead, a peripheral nerve block catheter will be secured to the skin surface and connected to a CADD™ pump. As the catheter is taped to the skin surface the control group patients will not be exposed to the risks of peripheral nerve block placement. | Other | Placebo |
Primary outcome
Opioid consumption
Time frame: 12 hours
Cumulative opioid consumption in milligrams of morphine in the first 12 hours after surgery.
6 secondary outcomes
Opioid consumption in 24 hours
Time frame: 24 hours post-operatively
Time to extubation
Time frame: 24 hours
Pain score
Time frame: Every 6 hours for 24 hours post-operatively
ICU length of stay
Time frame: 2 weeks
Surgical site infection rate
Time frame: 4 weeks
Local anesthetic systemic toxicity effects
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Study published by different group; this study would not add to the existing knowledge.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Background: PubMed 32032103Kelava M, Alfirevic A, Bustamante S, Hargrave J, Marciniak D. Regional Anesthesia in Cardiac Surgery: An Overview of Fascial Plane Chest Wall Blocks. Anesth Analg. 2020 Jul;131(1):127-135. doi: 10.1213/ANE.0000000000004682.
- Background: PubMed 31360703Fujii S, Bairagi R, Roche M, Zhou JR. Transversus Thoracis Muscle Plane Block. Biomed Res Int. 2019 Jul 7;2019:1716365. doi: 10.1155/2019/1716365. eCollection 2019.
- Background: PubMed 34022969Lloyd-Donald P, Lee WS, Hooper JW, Lee DK, Moore A, Chandra N, McCall P, Seevanayagam S, Matalanis G, Warrillow S, Weinberg L. Fast-track recovery program after cardiac surgery in a teaching hospital: a quality improvement initiative. BMC Res Notes. 2021 May 22;14(1):201. doi: 10.1186/s13104-021-05620-w.
- Background: PubMed 32275036Kar P, Ramachandran G. Pain relief following sternotomy in conventional cardiac surgery: A review of non neuraxial regional nerve blocks. Ann Card Anaesth. 2020 Apr-Jun;23(2):200-208. doi: 10.4103/aca.ACA_241_18.
- Background: PubMed 24396082de la Torre PA, Garcia PD, Alvarez SL, Miguel FJ, Perez MF. A novel ultrasound-guided block: a promising alternative for breast analgesia. Aesthet Surg J. 2014 Jan 1;34(1):198-200. doi: 10.1177/1090820X13515902. No abstract available.
- Background: PubMed 15616047McDonald SB, Jacobsohn E, Kopacz DJ, Desphande S, Helman JD, Salinas F, Hall RA. Parasternal block and local anesthetic infiltration with levobupivacaine after cardiac surgery with desflurane: the effect on postoperative pain, pulmonary function, and tracheal extubation times. Anesth Analg. 2005 Jan;100(1):25-32. doi: 10.1213/01.ANE.0000139652.84897.BD.
- Background: PubMed 25566704Nasr DA, Abdelhamid HM, Mohsen M, Aly AH. The analgesic efficacy of continuous presternal bupivacaine infusion through a single catheter after cardiac surgery. Ann Card Anaesth. 2015 Jan-Mar;18(1):15-20. doi: 10.4103/0971-9784.148314.
- Background: PubMed 30170012Lee CY, Robinson DA, Johnson CA Jr, Zhang Y, Wong J, Joshi DJ, Wu TT, Knight PA. A Randomized Controlled Trial of Liposomal Bupivacaine Parasternal Intercostal Block for Sternotomy. Ann Thorac Surg. 2019 Jan;107(1):128-134. doi: 10.1016/j.athoracsur.2018.06.081. Epub 2018 Aug 28.
- Background: PubMed 33426660Chin KJ, Versyck B, Pawa A. Ultrasound-guided fascial plane blocks of the chest wall: a state-of-the-art review. Anaesthesia. 2021 Jan;76 Suppl 1:110-126. doi: 10.1111/anae.15276.
- Background: PubMed 26693665Nielsen S, Degenhardt L, Hoban B, Gisev N. A synthesis of oral morphine equivalents (OME) for opioid utilisation studies. Pharmacoepidemiol Drug Saf. 2016 Jun;25(6):733-7. doi: 10.1002/pds.3945. Epub 2015 Dec 22.
- 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.
Wing Lam principal investigator
University of Alberta
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 Pectointercostal fascia blocks in people with Post-operative Pain, run by University of Alberta at 1 site in Canada.
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 2 inclusion and 11 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: stopped early, as of the sponsor's last update on 18 Dec 2023. 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 Canada. 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 stopped early (reason given: Study published by different group; this study would not add to the existing knowledge.). Results are not available in the source record.
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: 12 hours). 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 NCT05146453, which also lists 10 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 18 Dec 2023.