Clinical trial NCT05266378: Pectoralis Nerve Block and Quality of Recovery in Mastectomy Patients
Official title: The Effect of Pectoralis Nerve Block on Quality of Recovery in Patients Undergoing Breast-conservative Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 156
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Control arm: Conventional Anesthesia
2. Interventional arm: Conventional Anesthesia with pectoralis nerve block.
Primary purpose: SUPPORTIVE_CARE

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)

Eligibility criteria: 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

Primary outcomes:
measure: QoR-15
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Intensity of pain
timeFrame: Postoperative day 0, 1
Other outcomes:
measure: Preoperative psychological factors: HADS
timeFrame: 1-5 days before surgery, 1st OPD visit after surgery
measure: Preoperative psychological factors: EQ-5D
timeFrame: 1-5 days before surgery, 1st OPD visit after surgery
measure: Preoperative psychological factors and pain sensitivity test: PHQ-15
timeFrame: 1-5 days before surgery, 1st OPD visit after surgery
measure: Preoperative psychological factors and pain sensitivity test: pain catastrophizing scale
timeFrame: 1-5 days before surgery, 1st OPD visit after surgery
measure: Preoperative psychological factors: big five inventory
timeFrame: 1-5 days before surgery, 1st OPD visit after surgery
measure: Preoperative psychological factors: HAM-A&D
timeFrame: 1-5 days before surgery, 1st OPD visit after surgery
measure: Patient State Index
timeFrame: perioperative period
measure: analgesic nociception index
timeFrame: perioperative period
Locations:
city: Seoul
country: Korea, Republic of
facility: Young Song
Study officials:
References:
citation: 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.