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Completed

NCT Number: NCT05448638

Transversus Thoracic Muscle Plane Combined With Pectoral Nerves Block for Breast Cancer Surgery

This is a prospective, randomized, controlled trial for evaluating the efficacy of addition of transversus thoracic muscle plane block to pectoral nerves block versus pectoral nerves block for quality of recovery scores in breast cancer surgery.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

About this study

The pectoral nerves (PECS) block cannot block the most internal mammary region, whereas a transversus thoracic muscle plane (TTP) block can. The combination of PECS and TTP blocks may be suitable for breast cancer surgery. We studied patients undergoing breast cancer surgery to assess whether the combination of PECS and TTP blocks provides better postoperative recovery than PECS block alone.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female, 18-80 years of age
  • American Society of Anesthesiologists physical status I-III
  • patients having elective unilateral breast cancer surgery

Exclusion criteria

  • contraindication to nerve block
  • inability to understand or communicate with research personnel
  • chronic use of opioids or nonsteroidal anti-inflammatory drugs
  • pregnancy

Treatment and study plan

the combination of transversus thoracic muscle plane and pectoral nerves blocks

Procedure

For the pectoral nerves block, 0.375% ropivacaine , 10ml was injected between the pectoralis major and pectoralis minor and 20 ml above the serratus anterior muscle. For the transversus thoracic muscle plane block, ropivacaine 0.375%,15ml was injected between the transversus thoracic muscle and the internal intercostal muscle.

the pectoral nerves block only

Procedure

For the pectoral nerves block, 0.375% ropivacaine , 10ml was injected between the pectoralis major and pectoralis minor and 20 ml above the serratus anterior muscle.

Primary outcomes

  1. the quality of recovery-15 questionnaire (QoR-15)

    Time frame: at 24 hours after surgery

    The QoR-15 is a validated short-form postoperative quality of recovery score. Fifteen questions assess five domains of patient health-related quality of life: pain; comfort; physical independence; psychological support; and emotional state. Each question uses an 11-point rating scale, in which the maximum score is 150, denoting excellent recovery.

    • Able to breathe easily
    • Been able to enjoy food
    • Feeling rested
    • Have had a good sleep
    • Able to look after personal toilet and hygiene unaided
    • Able to communicate with family or friends
    • Getting support from hospital doctors and nurses
    • Able to return to work or usual home activities
    • Feeling comfortable and in control
    • Having a feeling of general well-being
    • Moderate pain
    • Severe pain
    • Nausea or vomiting
    • Feeling worried or anxious
    • Feeling sad or depressed

Secondary outcomes

  1. NRS score for rest and coughing pain

    Time frame: at 1, 6, 24, 48 hours after surgery

    Postoperative pain at rest and during coughing was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain)

  2. consumption of opioid converted to IV morphine equivalents

    Time frame: during 24 hours after surgery

    opioids given postoperatively converted to IV morphine equivalents

  3. the incidence of postoperative hypotension

    Time frame: during 48 hours after surgery

    Adverse reactions related to opioid

  4. the incidence of nausea and vomiting

    Time frame: during 48 hours after surgery

    Adverse reactions related to opioid

  5. the incidence of pruritus

    Time frame: during 48 hours after surgery

    Adverse reactions related to opioid

  6. the incidence of respiratory depression

    Time frame: during 48 hours after surgery

    Adverse reactions related to opioid

  7. time to urethral catheter removal in hours

    Time frame: through study completion, an average of 24-36 hours

    Time tourethral catheter removal after surgery

  8. postoperative hospital stay in days

    Time frame: through study completion, an average of 5-7 days

    The time from operation to discharge

  9. intra-operative opioid requirements

    Time frame: through the anesthesia process, an average of 1.5-2.5h

    opioids given intra-operatively

  10. the block-related outcomes

    Time frame: through study completion, an average of 5-7 days

    the incidence of block-related complications (accidental intravascular injection, local anaesthetic systemic toxicity, haematoma and pneumothorax); and incidence of patient-reported transient neurological complications (paraesthesia or sensory deficit)

  11. the Brief Pain Inventory

    Time frame: at 3 months after surgery.

    The Brief Pain Inventory instrument assesses 2 domains: pain and pain-related interference with physical and emotional functioning.

    • pain at its worst in the last 24 hours
    • pain at least in the last 24 hours
    • describe your pain on average
    • how much pain do you have right now
    • interference with general activity
    • interference with working ability
    • interference with work
    • interference with mood
    • interference with relations with other people
    • interference with sleep
    • interference with enjoyment of life

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

Quality of Recovery Scores in Transversus Thoracic Muscle Plane Combined With Pectoral Nerves Block Versus Pectoral Nerves Block for Breast Cancer Surgery: a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2022
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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