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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Block group | Experimental | The group undergoing PECs block |
|
| Control group | Placebo Comparator | The group not receiving PECs block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PECs block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| QoR-15 | To compare the difference in the quality of recovery between groups, the QoR-15 questionnaire is administered on the 1st day after surgery. | Postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of pain | Intensity of pain will be recorded by using VAS (0-10). | Postoperative day 0, 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative psychological factors: HADS | Presence of anxiety and depression symptoms will be assessed by HADS (Hospital Anxiety and Depression Scale) questionnaire. | 1-5 days before surgery, 1st OPD visit after surgery |
| Preoperative psychological factors: EQ-5D |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young Song | Contact | 82-2-2019-6692 | nearmyheart@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Young Song | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33492696 | Background | Abdallah FW, Patel V, Madjdpour C, Cil T, Brull R. Quality of recovery scores in deep serratus anterior plane block vs. sham block in ambulatory breast cancer surgery: a randomised controlled trial. Anaesthesia. 2021 Sep;76(9):1190-1197. doi: 10.1111/anae.15373. Epub 2021 Jan 25. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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.
|
| Not receiving PECs Block | Other | In this group, the PECs block was not implemented. |
|
Presence of anxiety and depression symptoms will be assessed by EQ-5D. |
| 1-5 days before surgery, 1st OPD visit after surgery |
| Preoperative psychological factors and pain sensitivity test: PHQ-15 | Presence of anxiety, depression symptoms and pain sensitivity will be assessed by PHQ-15. | 1-5 days before surgery, 1st OPD visit after surgery |
| Preoperative psychological factors and pain sensitivity test: pain catastrophizing scale | Presence of anxiety, depression symptoms and pain sensitivity will be assessed by pain catastrophizing scale. | 1-5 days before surgery, 1st OPD visit after surgery |
| Preoperative psychological factors: big five inventory | Presence of anxiety and depression symptoms will be assessed by big five inventory. | 1-5 days before surgery, 1st OPD visit after surgery |
| Preoperative psychological factors: HAM-A&D | Presence of anxiety and depression symptoms will be assessed by HAM-A&D. | 1-5 days before surgery, 1st OPD visit after surgery |
| Patient State Index | 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 | perioperative period |
| analgesic nociception index | Intensity of pain will be recorded by using analgesic nociception index during operation | perioperative period |
| D017437 |
| Skin and Connective Tissue Diseases |