Breast Cancer
Conditions
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.
Interventions
PROCEDUREthe 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.
PROCEDUREthe 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.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| consumption of opioid converted to IV morphine equivalents | during 24 hours after surgery | opioids given postoperatively converted to IV morphine equivalents |
| the incidence of postoperative hypotension | during 48 hours after surgery | Adverse reactions related to opioid |
| the incidence of nausea and vomiting | during 48 hours after surgery | Adverse reactions related to opioid |
| the incidence of pruritus | during 48 hours after surgery | Adverse reactions related to opioid |
| the incidence of respiratory depression | during 48 hours after surgery | Adverse reactions related to opioid |
| postoperative hospital stay in days | through study completion, an average of 5-7 days | The time from operation to discharge |
| intra-operative opioid requirements | through the anesthesia process, an average of 1.5-2.5h | opioids given intra-operatively |
| 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 |
| time to urethral catheter removal in hours | through study completion, an average of 24-36 hours | Time tourethral catheter removal after surgery |
Countries
China
Outcome results
None listed