Pectoralis Nerve Block and Quality of Recovery in Mastectomy Patients

Breast Cancer Clinical Trial

Official title:

The Effect of Pectoralis Nerve Block on Quality of Recovery in Patients Undergoing Breast-conservative Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05266378
• Other study ID #: 3-2021-0468
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: March 24, 2025

Study information

• Verified date: January 2023
• Source: Gangnam Severance Hospital
• Contact: Young Song
• Phone: 82-2-2019-6692
• Email: nearmyheart[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: March 24, 2025
• Est. primary completion date: February 23, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• PECs 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.

Other:
• Not receiving PECs Block
In this group, the PECs block was not implemented.

Locations

Country	Name	City	State
Korea, Republic of	Young Song	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Preoperative psychological factors: EQ-5D	Presence of anxiety and depression symptoms will be assessed by EQ-5D.	1-5 days before surgery, 1st OPD visit after surgery
Other	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
Other	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
Other	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
Other	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
Other	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
Other	analgesic nociception index	Intensity of pain will be recorded by using analgesic nociception index during operation	perioperative period
Primary	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
Secondary	Intensity of pain	Intensity of pain will be recorded by using VAS (0-10).	Postoperative day 0, 1