Breast Cancer
Conditions
Brief summary
Effects of pectoralis nerve block on quality of recovery after breast surgery has been debated. We hypothesized there might exist relevant psychosocial factor or variable of pain sensitivity which would influence on the benefit of nerve block. This study aims to assess effect of pectoralis nerve block on QoR-15 score in subgroups stratified by such factors.
Detailed description
Study population All of patients will undergo partial mastectomy. 140 patients will be enrolled. Intervention Pectoralis nerve block will be performed in the Block group. Psychosocial factor screening Pain-detect, HADS, EQ-5D, PHQ-15 (somatic symptom), PCS (pain catastrophizing), BFI (big five inventory), HAM-A&D, Pressure algometry (Pain sensitivity), Quantitative sensory test (pinprick) Study endpoints Quality of recovery (QoR)-15 Pain visual analogue scale Opioid consumption Breast Cancer Pain Questionnaire (BCPQ)
Interventions
PROCEDUREPECs block
The PECs block is performed immediately after induction of anesthesia, and 0.375% concentration of ropivacaine (carbiropivacaine injection, Fresinius Kavi Korea Co., Ltd.) is used with a 25 G 5 cm (or 8 cm) needle to induce ultrasound-guided pectoralis major (pectoralis major). 10mL (PECs I block) into the fascia between the pectoralis minor muscle) and the pectoralis minor muscle, and 20mL (PECs II block) between the pectoralis minor and serratus anterior muscle.
OTHERNot receiving PECs Block
In this group, the PECs block was not implemented.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
All researchers other than the anesthesiologist who manage the randomization table and the medical staff in charge of the patient must keep the group assignment blinded until the end of the study.
Intervention model description
1. Control arm: Conventional Anesthesia 2. Interventional arm: Conventional Anesthesia with pectoralis nerve block.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 20 to 80 years who underwent partial mastectomy for breast cancer.
Exclusion criteria
* Patients with a history of previous breast surgery * Patients with a history of adverse reactions to local anesthetics * Patients with a history of drug addiction * Patients with cancer other than breast * Patients with chronic pain who require analgesics * History of hospitalization for psychiatric disorders * Preoperative pulse oximetry (SpO2) \< 95 % * Left ventricular ejection fraction \< 40% * Moderate or severe hepatic impairment * Body mass index over 35 kg/m2 * Blood clotting disorders * Pregnant/lactating women * Inability to understand consent forms and answer research questionnaires due to cognitive impairment * Unable to read consent form (eg illiterate, foreigner, etc.) * do not perform axillary lymph node dissection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QoR-15 | Postoperative day 1 | To compare the difference in the quality of recovery between groups, the QoR-15 questionnaire is administered on the 1st day after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of pain | Postoperative day 0, 1 | Intensity of pain will be recorded by using VAS (0-10). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Preoperative psychological factors: EQ-5D | 1-5 days before surgery, 1st OPD visit after surgery | Presence of anxiety and depression symptoms will be assessed by EQ-5D. |
| Preoperative psychological factors and pain sensitivity test: PHQ-15 | 1-5 days before surgery, 1st OPD visit after surgery | Presence of anxiety, depression symptoms and pain sensitivity will be assessed by PHQ-15. |
| Preoperative psychological factors and pain sensitivity test: pain catastrophizing scale | 1-5 days before surgery, 1st OPD visit after surgery | Presence of anxiety, depression symptoms and pain sensitivity will be assessed by pain catastrophizing scale. |
| Preoperative psychological factors: big five inventory | 1-5 days before surgery, 1st OPD visit after surgery | Presence of anxiety and depression symptoms will be assessed by big five inventory. |
| Preoperative psychological factors: HAM-A&D | 1-5 days before surgery, 1st OPD visit after surgery | Presence of anxiety and depression symptoms will be assessed by HAM-A&D. |
| Patient State Index | perioperative period | Depth of anesthesia will be recorded by using frontal electroencephalogram (Patient State Index, The PSi is a processed EEG parameter that is related to the effect of anesthetic agents, and takes into consideration, among other factors: (1) changes in power in various EEG frequency bands; (2) changes in symmetry and synchronization between critical brain regions; and (3) the inhibition of regions of the frontal cortex.) during operation |
| analgesic nociception index | perioperative period | Intensity of pain will be recorded by using analgesic nociception index during operation |
| Preoperative psychological factors: HADS | 1-5 days before surgery, 1st OPD visit after surgery | Presence of anxiety and depression symptoms will be assessed by HADS (Hospital Anxiety and Depression Scale) questionnaire. |
Countries
South Korea
Contacts
Primary ContactYoung Song
Outcome results
None listed