Pain, PostoperativeNCT04596163
Transversus Thoracis Muscle Plane Block for Sternotomy Pain in Cardiac Surgery
A study testing Transversus thoracis muscle plane block in people with Pain, Postoperative and Surgical Wound, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Sternotomy pain is usually significant after cardiac surgery. Analgesic options for sternotomy in cardiac surgery are often limited. Poorly controlled acute pain is an important factor to development of chronic postsurgical pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Surgical Wound, Cardiac Event
- What is being tested?
- Transversus thoracis muscle plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Oct 2020to 22 Apr 2023
- Phase
- Interventional
- 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
- Elective CABG, aortic valve repair/replacement, mitral valve repair/replacement, or combined CABG/valve procedure
Who cannot join
- emergency surgery
- redo surgery
- history of thoracotomy or mastectomy
- history of chronic pain or regular analgesic use (except paracetamol and NSAID)
- history of psychiatric illnesses or illicit drug use
- renal failure with eGFR <30ml/min or on renal replacement therapy
Show all 9Show fewer
- mortality or require re-sternotomy within 24h after operation
- intraoperative use of remifentanil
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transversus Thoracis Muscle Plane Block for Acute and Chronic Pain Management in Cardiac Surgical Patients Requiring Sternotomy: a Prospective Randomized Controlled Trial
Sternotomy pain is usually significant after cardiac surgery. Analgesic options for sternotomy in cardiac surgery are often limited. Poorly controlled acute pain is an important factor to development of chronic postsurgical pain. The transversus thoracis muscle plane (TTP) block is a novel technique that provides analgesia to anterior chest wall. A double-blinded RCT is conducted to assess the efficacy of applying TTP block as an adjunct to analgesia in cardiac surgery.
Read the detailed description
Chronic postsurgical pain (CPSP) is defined as the persistence of pain at surgical site or referred area, at least 3 months following the surgical procedure. CPSP after median sternotomy is not uncommon after cardiac surgery. The reported incidence ranges from 28% to 56% up to 2 years postoperatively. A number of factors can contribute to the variation in incidence, including the variations in presentation of chronic post-sternotomy pain and under-reporting from patients. Given the nature of cardiac surgery and considerable anxiety of patients at perioperative period, patients would tend to live with the chronic pain and rationalize it as a normal consequence of the surgery. Patients therefore may not report any symptoms, resulting in a delay in diagnosis of chronic post-sternotomy pain.
The mechanisms for development of CPSP after sternotomy are not fully known. The up-regulation, activation and neural sensitization during the acute pain phase are important factors to the development of chronic pain. Causes of pain from sternotomy include neuropathy from anterior intercostal nerves entrapment or injury during surgical dissection and internal mammary artery harvesting, musculoskeletal injury from surgical incision and dissection, sternal fracture or incomplete bone healing, and development of sternal wound infections. Poorly controlled acute pain in the perioperative period can trigger central sensitization, a stepwise modification of spinal pain pathways involving protein synthesis and synaptic strength, which can lead to hyperalgesia and chronic pain. Therefore, good perioperative acute pain control not only provides postoperative pain relief, but also prevents occurrence of chronic pain.
In most centres, opioids such as fentanyl and morphine are used mainly for the management of acute pain after cardiac surgery. However, perioperative opioids are known to be associated with dose-dependent side effects such as nausea and vomiting, pruritis, respiratory depression, postoperative chronic opioid use and increased risk of chronic pain. Multimodal approach such as the use of NSAIDs may not be optimal after cardiac surgery due to the risk of bleeding and renal failure. Regional analgesia has opioid-sparing effect and seems to be a good choice for perioperative anaglesia. Regional techniques such as thoracic epidural and paravertebral blocks have been described but they are not ideal due to the potential complications from systemic heparinization in cardiac surgery. Erector spinae plane (ESP) block was reported to decrease perioperative morphine consumption and early postoperative pain score. However, the transverse process tip is not always easy to visualize on ultrasound, especially in obese patients, resulting in variation in ESP block efficacy.
Transversus thoracis muscle plane (TTP) block covers the anterior branches of intercostal nerves T2 to T6. It has been described in cardiac surgical patients that provides analgesia for sternotomy. TTP block is a superficial block and therefore is relatively safe when compared with thoracic epidural and paravertebral nerve block during heparinization. The investigators hypothesized that pre-emptive TTP block can provide effective perioperative analgesia and prevent the occurrence of CPSP in cardiac surgical patients requiring median sternotomy. A prospective, double-blinded randomized controlled trial was conducted to assess the analgesic efficacy of TTP block in open cardiac surgery.
- Conditions
- Pain, Postoperative, Surgical Wound, Cardiac Event
- Being tested
- Transversus thoracis muscle plane block
- Keywords
- Regional anaesthesia, Cardiac surgery
- Medical subject headings
- Pain, Postoperative, Surgical Wound, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus thoracis muscle plane blockProcedure or surgery
After general anaesthesia, transversus thoracis plane (TTP) block, a kind of regional block will be performed near both sides of the sternum under ultrasound guidance using either levobupivacaine or normal saline to both groups of patients. The end point for injection is the fluid spread along the plane just superficial to the transversus thoracis muscle, together with the downward displacement of the pleura.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Ultrasound guided Regional block using 0.25% levobupivacaine (local anaesthetic agent) 20ml (50mg) on each side of the sternum over 1-2 minutes after general anaesthesia before surgery. Receives: Procedure: Transversus thoracis muscle plane block |
| Control | Placebo comparator | Ultrasound guided Regional block using 20ml of 0.9% normal saline on each side of the sternum after general anaesthesia before surgery. Receives: Procedure: Transversus thoracis muscle plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
The total amount of opioid (mg) used during the surgery
Measured: Once at the end of the surgery
Secondary outcomes (10)
Percentage blood pressure change
The percentage changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) between the baseline (before surgery) and within 10 minutes after skin incision for sternotomy
Measured: From 5 minutes before skin incision to 10 minutes after skin incision at 1 minute interval ( a total of 15 time point)
Percentage heart rate change
Heart rate (HR) between the baseline (before surgery) and their peaks within 10 minutes of skin incision for sternotomy.
Measured: From 5 minutes before incision to 10 minutes after skin incision at 1 minute interval (a total of 15 time points)
Morphine consumption
The amount of morphine (mg) used after the surgery for pain control
Measured: up to 72 hours postoperatively
Length of hospital stay
duration of hospital stay (in days)
Measured: Immediately after the surgery up to the day of patient discharge
Intensive Care unit (ICU) stay
duration of ICU stay (in hours)
Measured: Immediately after the surgery up to the time of ICU discharge
Pain score
A visual analogue scale of 0-10 (0=no pain, 10=worst pain) will be used to grade the pain score. Patients will be asked to rate the intensity of postoperative pain at rest and on three maximal coughs.
Measured: At 8, 12, 24, 48 and 72 hours after TTP block and on day 7 after surgery (6 time points).
Peak expiratory flow rate
Measured with a spirometer at baseline on the day before operation and postoperatively at the time of assessing pain score. The higher the result means the better the lung function of the patient.
Measured: Once as baseline on the day before operation and at 6 time points after surgery (ie. at 8, 12, 24, 48, 72 hours after block and on day 7 after surgery).
Forced expiratory volume in 1 second
Measured with a spirometer at baseline on the day before operation and postoperatively at the time of assessing pain score. The higher the result means the better the lung function of the patient.
Measured: Once as baseline on the day before operation and at 6 time points after surgery (ie. at 8, 12, 24, 48, 72 hours after block and on day 7 after surgery).
Brief Pain Interference Scale
It will be used to evaluate the extent of pain interfering with various components of functioning, including physical functioning, emotional functioning and sleep within the last 24 hours at 3 and 6 months after surgery (a score of 0-10; 0=no interference at all, 10= the worst interference due to pain).
Measured: at 3-month and 6-month after surgery
Pain Catastrophizing Scale
Pain Catastrophizing Scale (HK-PCS) will be used to assess patients' negative cognitive-affective responses to pain within the last 24 hours at 3 and 6 months after surgery. Score 0-100 (0=no pain related anxiety; 100=most severe pain related anxiety)
Measured: at 3-month and 6-month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start15 Oct 2020
- Primary completion22 Oct 2022
- Study completion22 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centred, double-blinded, randomized, placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WONG MAN KIN, Chinese University of Hong Kong
- Investigators
- Henry Man Kin Wong, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596163
- Sponsor's protocol ID
- 2020.371-T
- Status last verified
- Jul 2023
- First submitted
- 6 Oct 2020
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Thoracis Muscle Plane Block for Acute and Chronic Pain Management in Cardiac Surgical Patients Requiring Sternotomy: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04596163
- Acronym / sponsor ID
- 2020.371-T
- Conditions
- Pain, Postoperative, Surgical Wound, Cardiac Event
- Keywords
- Regional anaesthesia, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 22 Oct 2022 (actual)
- Study completion
- 22 Apr 2023 (actual)
- First posted
- 22 Oct 2020 (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.
Sternotomy pain is usually significant after cardiac surgery. Analgesic options for sternotomy in cardiac surgery are often limited. Poorly controlled acute pain is an important factor to development of chronic postsurgical pain. The transversus thoracis muscle plane (TTP) block is a novel technique that provides analgesia to anterior chest wall. A double-blinded RCT is conducted to assess the efficacy of applying TTP block as an adjunct to analgesia in cardiac surgery.
Detailed description
Chronic postsurgical pain (CPSP) is defined as the persistence of pain at surgical site or referred area, at least 3 months following the surgical procedure. CPSP after median sternotomy is not uncommon after cardiac surgery. The reported incidence ranges from 28% to 56% up to 2 years postoperatively. A number of factors can contribute to the variation in incidence, including the variations in presentation of chronic post-sternotomy pain and under-reporting from patients. Given the nature of cardiac surgery and considerable anxiety of patients at perioperative period, patients would tend to live with the chronic pain and rationalize it as a normal consequence of the surgery. Patients therefore may not report any symptoms, resulting in a delay in diagnosis of chronic post-sternotomy pain.
The mechanisms for development of CPSP after sternotomy are not fully known. The up-regulation, activation and neural sensitization during the acute pain phase are important factors to the development of chronic pain. Causes of pain from sternotomy include neuropathy from anterior intercostal nerves entrapment or injury during surgical dissection and internal mammary artery harvesting, musculoskeletal injury from surgical incision and dissection, sternal fracture or incomplete bone healing, and development of sternal wound infections. Poorly controlled acute pain in the perioperative period can trigger central sensitization, a stepwise modification of spinal pain pathways involving protein synthesis and synaptic strength, which can lead to hyperalgesia and chronic pain. Therefore, good perioperative acute pain control not only provides postoperative pain relief, but also prevents occurrence of chronic pain.
In most centres, opioids such as fentanyl and morphine are used mainly for the management of acute pain after cardiac surgery. However, perioperative opioids are known to be associated with dose-dependent side effects such as nausea and vomiting, pruritis, respiratory depression, postoperative chronic opioid use and increased risk of chronic pain. Multimodal approach such as the use of NSAIDs may not be optimal after cardiac surgery due to the risk of bleeding and renal failure. Regional analgesia has opioid-sparing effect and seems to be a good choice for perioperative anaglesia. Regional techniques such as thoracic epidural and paravertebral blocks have been described but they are not ideal due to the potential complications from systemic heparinization in cardiac surgery. Erector spinae plane (ESP) block was reported to decrease perioperative morphine consumption and early postoperative pain score. However, the transverse process tip is not always easy to visualize on ultrasound, especially in obese patients, resulting in variation in ESP block efficacy.
Transversus thoracis muscle plane (TTP) block covers the anterior branches of intercostal nerves T2 to T6. It has been described in cardiac surgical patients that provides analgesia for sternotomy. TTP block is a superficial block and therefore is relatively safe when compared with thoracic epidural and paravertebral nerve block during heparinization. The investigators hypothesized that pre-emptive TTP block can provide effective perioperative analgesia and prevent the occurrence of CPSP in cardiac surgical patients requiring median sternotomy. A prospective, double-blinded randomized controlled trial was conducted to assess the analgesic efficacy of TTP block in open cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centred, double-blinded, randomized, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Procedure: Transversus thoracis muscle plane blockUltrasound guided Regional block using 0.25% levobupivacaine (local anaesthetic agent) 20ml (50mg) on each side of the sternum over 1-2 minutes after general anaesthesia before surgery. |
| Control | Placebo comparator | Procedure: Transversus thoracis muscle plane blockUltrasound guided Regional block using 20ml of 0.9% normal saline on each side of the sternum after general anaesthesia before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective CABG, aortic valve repair/replacement, mitral valve repair/replacement, or combined CABG/valve procedure
Key exclusion criteria (9 listed)
- emergency surgery
- redo surgery
- history of thoracotomy or mastectomy
- history of chronic pain or regular analgesic use (except paracetamol and NSAID)
- history of psychiatric illnesses or illicit drug use
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 |
|---|---|---|
| Transversus thoracis muscle plane blockAfter general anaesthesia, transversus thoracis plane (TTP) block, a kind of regional block will be performed near both sides of the sternum under ultrasound guidance using either levobupivacaine or normal saline to both groups of patients. The end point for injection is the fluid spread along the plane just superficial to the transversus thoracis muscle, together with the downward displacement of the pleura. | Procedure or surgery | Control, Intervention |
Primary outcome
Opioid consumption
Time frame: Once at the end of the surgery
The total amount of opioid (mg) used during the surgery
10 secondary outcomes
Percentage blood pressure change
Time frame: From 5 minutes before skin incision to 10 minutes after skin incision at 1 minute interval ( a total of 15 time point)
Percentage heart rate change
Time frame: From 5 minutes before incision to 10 minutes after skin incision at 1 minute interval (a total of 15 time points)
Morphine consumption
Time frame: up to 72 hours postoperatively
Length of hospital stay
Time frame: Immediately after the surgery up to the day of patient discharge
Intensive Care unit (ICU) stay
Time frame: Immediately after the surgery up to the time of ICU discharge
Pain score
Time frame: At 8, 12, 24, 48 and 72 hours after TTP block and on day 7 after surgery (6 time points).
Peak expiratory flow rate
Time frame: Once as baseline on the day before operation and at 6 time points after surgery (ie. at 8, 12, 24, 48, 72 hours after block and on day 7 after surgery).
Forced expiratory volume in 1 second
Time frame: Once as baseline on the day before operation and at 6 time points after surgery (ie. at 8, 12, 24, 48, 72 hours after block and on day 7 after surgery).
Brief Pain Interference Scale
Time frame: at 3-month and 6-month after surgery
Pain Catastrophizing Scale
Time frame: at 3-month and 6-month after surgery
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 13 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Henry Man Kin Wong, MBChB principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus thoracis muscle plane block in people with Pain, Postoperative and Surgical Wound, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 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 13 Jul 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 Hong Kong. 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.
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: Once at the end of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2023.