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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Hong Kong1 site
  • Prince of Wales Hospital

    Hong Kong

Other trials in Hong Kong

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.

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 groups in NCT04596163
Study groupRoleWhat they receive
InterventionActive comparatorUltrasound 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
ControlPlacebo comparatorUltrasound 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.

  1. Opioid consumption

    The total amount of opioid (mg) used during the surgery

    Measured: Once at the end of the surgery

Secondary outcomes (10)
  1. 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)

  2. 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)

  3. Morphine consumption

    The amount of morphine (mg) used after the surgery for pain control

    Measured: up to 72 hours postoperatively

  4. Length of hospital stay

    duration of hospital stay (in days)

    Measured: Immediately after the surgery up to the day of patient discharge

  5. Intensive Care unit (ICU) stay

    duration of ICU stay (in hours)

    Measured: Immediately after the surgery up to the time of ICU discharge

  6. 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).

  7. 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).

  8. 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).

  9. 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

  10. 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.

  1. First posted22 Oct 2020
  2. Study start15 Oct 2020
  3. Primary completion22 Oct 2022
  4. Study completion22 Apr 2023

Resources

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)
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

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.

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