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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: the combination of transversus thoracic muscle plane and pectoral nerves blocks
* Procedure: the pectoral nerves block only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transversus thoracic muscle plane block+pectoral nerves block<br>the combination of transversus thoracic muscle plane and pectoral nerves blocks | Procedure: the combination of transversus thoracic muscle plane and pectoral nerves blocks<br>* 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.<br>|
| Active Comparator: pectoral nerves block<br>the pectoral nerves block only | Procedure: the pectoral nerves block only<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the quality of recovery-15 questionnaire (QoR-15) | 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 | at 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS score for rest and coughing pain | 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) | at 1, 6, 24, 48 hours after surgery | 
| consumption of opioid converted to IV morphine equivalents | opioids given postoperatively converted to IV morphine equivalents | during 24 hours after surgery | 
| the incidence of postoperative hypotension | Adverse reactions related to opioid | during 48 hours after surgery | 
| the incidence of nausea and vomiting | Adverse reactions related to opioid | during 48 hours after surgery | 
| the incidence of pruritus | Adverse reactions related to opioid | during 48 hours after surgery | 
| the incidence of respiratory depression | Adverse reactions related to opioid | during 48 hours after surgery | 
| time to urethral catheter removal in hours | Time tourethral catheter removal after surgery | through study completion, an average of 24-36 hours | 
| postoperative hospital stay in days | The time from operation to discharge | through study completion, an average of 5-7 days | 
| intra-operative opioid requirements | opioids given intra-operatively | through the anesthesia process, an average of 1.5-2.5h | 
| the block-related outcomes | 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) | through study completion, an average of 5-7 days | 
| the Brief Pain Inventory | 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 | at 3 months after surgery. |