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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: the combination of transversus thoracic muscle plane and pectoral nerves blocks; Procedure: the pectoral nerves block only

• Registration Number: NCT05448638
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-07-03
• Study First Submitted QC: 2022-07-03
• Study First Posted: 2022-07-07
• Study Start: 2022-07-12
• Primary Completion: 2023-05-05
• Study Completion: 2023-08-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transversus thoracic muscle plane block+pectoral nerves block	the combination of transversus thoracic muscle plane and pectoral nerves blocks	the combination of transversus thoracic muscle plane and pectoral nerves blocks
pectoral nerves block	the pectoral nerves block only	the pectoral nerves block only

Primary Outcome Measures

Name	Time	Method
the quality of recovery-15 questionnaire (QoR-15)	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.; 1. Able to breathe easily; 2. Been able to enjoy food; 3. Feeling rested; 4. Have had a good sleep; 5. Able to look after personal toilet and hygiene unaided; 6. Able to communicate with family or friends; 7. Getting support from hospital doctors and nurses; 8. Able to return to work or usual home activities; 9. Feeling comfortable and in control; 10. Having a feeling of general well-being; 11. Moderate pain; 12. Severe pain; 13. Nausea or vomiting; 14. Feeling worried or anxious; 15. Feeling sad or depressed

Secondary Outcome Measures

Name	Time	Method
the incidence of postoperative hypotension	during 48 hours after surgery	Adverse reactions related to opioid
the incidence of pruritus	during 48 hours after surgery	Adverse reactions related to opioid
NRS score for rest and coughing pain	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)
the incidence of nausea and vomiting	during 48 hours after surgery	Adverse reactions related to opioid
the block-related outcomes	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)
the Brief Pain Inventory	at 3 months after surgery.	The Brief Pain Inventory instrument assesses 2 domains: pain and pain-related interference with physical and emotional functioning.; 1. pain at its worst in the last 24 hours; 2. pain at least in the last 24 hours; 3. describe your pain on average; 4. how much pain do you have right now; 5. interference with general activity; 6. interference with working ability; 7. interference with work; 8. interference with mood; 9. interference with relations with other people; 10. interference with sleep; 11. interference with enjoyment of life
postoperative hospital stay in days	through study completion, an average of 5-7 days	The time from operation to discharge
the incidence of respiratory depression	during 48 hours after surgery	Adverse reactions related to opioid
consumption of opioid converted to IV morphine equivalents	during 24 hours after surgery	opioids given postoperatively converted to IV morphine equivalents
time to urethral catheter removal in hours	through study completion, an average of 24-36 hours	Time tourethral catheter removal after surgery
intra-operative opioid requirements	through the anesthesia process, an average of 1.5-2.5h	opioids given intra-operatively

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China