Transversus Thoracis Muscle Plane Block for Sternotomy Pain in Cardiac Surgery

Pain, Postoperative Clinical Trial

Official title:

Transversus Thoracis Muscle Plane Block for Acute and Chronic Pain Management in Cardiac Surgical Patients Requiring Sternotomy: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04596163
• Other study ID #: 2020.371-T
• Status: Completed
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: April 22, 2023

Study information

• Verified date: July 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: April 22, 2023
• Est. primary completion date: October 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective CABG, aortic valve repair/replacement, mitral valve repair/replacement, or combined CABG/valve procedure

Exclusion Criteria:

• 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
• mortality or require re-sternotomy within 24h after operation
• intraoperative use of remifentanil
• unable to provide informed consent

Related Conditions & MeSH terms

• Cardiac Event
• Cardiovascular Diseases
• Pain, Postoperative
• Surgical Wound

Intervention

Procedure:
• Transversus thoracis muscle plane block
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.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	The total amount of opioid (mg) used during the surgery	Once at the end of the surgery
Secondary	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	From 5 minutes before skin incision to 10 minutes after skin incision at 1 minute interval ( a total of 15 time point)
Secondary	Percentage heart rate change	Heart rate (HR) between the baseline (before surgery) and their peaks within 10 minutes of skin incision for sternotomy.	From 5 minutes before incision to 10 minutes after skin incision at 1 minute interval (a total of 15 time points)
Secondary	Morphine consumption	The amount of morphine (mg) used after the surgery for pain control	up to 72 hours postoperatively
Secondary	Length of hospital stay	duration of hospital stay (in days)	Immediately after the surgery up to the day of patient discharge
Secondary	Intensive Care unit (ICU) stay	duration of ICU stay (in hours)	Immediately after the surgery up to the time of ICU discharge
Secondary	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.	At 8, 12, 24, 48 and 72 hours after TTP block and on day 7 after surgery (6 time points).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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).	at 3-month and 6-month after surgery
Secondary	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)	at 3-month and 6-month after surgery