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Transversus Thoracis Muscle Plane Block for Sternotomy Pain in Cardiac Surgery

Primary Purpose

Pain, Postoperative, Surgical Wound, Cardiac Event

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Transversus thoracis muscle plane block
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Regional anaesthesia, Cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

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.

Ultrasound guided Regional block using 20ml of 0.9% normal saline on each side of the sternum after general anaesthesia before surgery.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Percentage heart rate change
Heart rate (HR) between the baseline (before surgery) and their peaks within 10 minutes of skin incision for sternotomy.
Morphine consumption
The amount of morphine (mg) used after the surgery for pain control
Length of hospital stay
duration of hospital stay (in days)
Intensive Care unit (ICU) stay
duration of ICU stay (in hours)
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.
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.
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.
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).
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)

Full Information

First Posted
October 6, 2020
Last Updated
July 12, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04596163
Brief Title
Transversus Thoracis Muscle Plane Block for Sternotomy Pain in Cardiac Surgery
Official Title
Transversus Thoracis Muscle Plane Block for Acute and Chronic Pain Management in Cardiac Surgical Patients Requiring Sternotomy: a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
October 22, 2022 (Actual)
Study Completion Date
April 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Surgical Wound, Cardiac Event
Keywords
Regional anaesthesia, Cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-centred, double-blinded, randomized, placebo-controlled trial
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Ultrasound guided Regional block using 20ml of 0.9% normal saline on each side of the sternum after general anaesthesia before surgery.
Intervention Type
Procedure
Intervention Name(s)
Transversus thoracis muscle plane block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Opioid consumption
Description
The total amount of opioid (mg) used during the surgery
Time Frame
Once at the end of the surgery
Secondary Outcome Measure Information:
Title
Percentage blood pressure change
Description
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
Time Frame
From 5 minutes before skin incision to 10 minutes after skin incision at 1 minute interval ( a total of 15 time point)
Title
Percentage heart rate change
Description
Heart rate (HR) between the baseline (before surgery) and their peaks within 10 minutes of skin incision for sternotomy.
Time Frame
From 5 minutes before incision to 10 minutes after skin incision at 1 minute interval (a total of 15 time points)
Title
Morphine consumption
Description
The amount of morphine (mg) used after the surgery for pain control
Time Frame
up to 72 hours postoperatively
Title
Length of hospital stay
Description
duration of hospital stay (in days)
Time Frame
Immediately after the surgery up to the day of patient discharge
Title
Intensive Care unit (ICU) stay
Description
duration of ICU stay (in hours)
Time Frame
Immediately after the surgery up to the time of ICU discharge
Title
Pain score
Description
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.
Time Frame
At 8, 12, 24, 48 and 72 hours after TTP block and on day 7 after surgery (6 time points).
Title
Peak expiratory flow rate
Description
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.
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).
Title
Forced expiratory volume in 1 second
Description
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.
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).
Title
Brief Pain Interference Scale
Description
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).
Time Frame
at 3-month and 6-month after surgery
Title
Pain Catastrophizing Scale
Description
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)
Time Frame
at 3-month and 6-month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Man Kin Wong, MBChB
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Transversus Thoracis Muscle Plane Block for Sternotomy Pain in Cardiac Surgery

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