Transversus Thoracis Muscle Plane Block for Sternotomy Pain in Cardiac Surgery

NCT04596163 | Completed

• 1 other identifier: 2020.371-T
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Surgical Wound; Cardiac Event

Keywords

Regional anaesthesia; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

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

  Once at the end of the surgery

Secondary Outcomes (10)

• Percentage blood pressure change

  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

  From 5 minutes before incision to 10 minutes after skin incision at 1 minute interval (a total of 15 time points)

• Morphine consumption

  up to 72 hours postoperatively

• Length of hospital stay

  Immediately after the surgery up to the day of patient discharge

• Intensive Care unit (ICU) stay

  Immediately after the surgery up to the time of ICU discharge

Study Arms (2)

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.

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.

Procedure: Transversus thoracis muscle plane block

Interventions

Transversus thoracis muscle plane block PROCEDURE

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.

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Pain, Postoperative; Surgical Wound; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Wounds and Injuries

Study Officials

• Henry Man Kin Wong, MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Clinical Assistant Professor

Model Details: Single-centred, double-blinded, randomized, placebo-controlled trial

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 22, 2020
• Study Start: October 15, 2020
• Primary Completion: October 22, 2022
• Study Completion: April 22, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)