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

Breast Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05448638
• Other study ID #: IRB-2022-348
• Status: Completed
• Phase: N/A
• Start date: July 12, 2022
• Est. completion date: August 5, 2023

Study information

• Verified date: November 2023
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: August 5, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• the combination of transversus thoracic muscle plane and pectoral nerves blocks
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
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.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	consumption of opioid converted to IV morphine equivalents	opioids given postoperatively converted to IV morphine equivalents	during 24 hours after surgery
Secondary	the incidence of postoperative hypotension	Adverse reactions related to opioid	during 48 hours after surgery
Secondary	the incidence of nausea and vomiting	Adverse reactions related to opioid	during 48 hours after surgery
Secondary	the incidence of pruritus	Adverse reactions related to opioid	during 48 hours after surgery
Secondary	the incidence of respiratory depression	Adverse reactions related to opioid	during 48 hours after surgery
Secondary	time to urethral catheter removal in hours	Time tourethral catheter removal after surgery	through study completion, an average of 24-36 hours
Secondary	postoperative hospital stay in days	The time from operation to discharge	through study completion, an average of 5-7 days
Secondary	intra-operative opioid requirements	opioids given intra-operatively	through the anesthesia process, an average of 1.5-2.5h
Secondary	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
Secondary	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.