The Impact of Pecs Blocks on Postmastectomy Pain Syndrome

Not Applicable

Completed

• Conditions: Pain Syndrome; Breast Cancer Female; Pain, Postoperative; Breast Cancer; Chronic Pain; Breast Neoplasms; Anesthesia; Breast Soft Tissue Neoplasm; Breast Pain
• Interventions: Other: no Pecs block; Other: Pecs block

• Registration Number: NCT04586751
• Lead Sponsor: Aretaieion University Hospital

Brief Summary

The aim of the present study is to investigate the incidence of chronic pain following breast cancer surgery in Cyprus, discover its associated risk factors and explore the impact of Pecs Blocks on the appearance of post mastectomy chronic pain symptoms

Detailed Description

Breast cancer is the commonest type of malignancy in women. Chronic postoperative neuropathic pain may appear either in the early postoperative period or at a later stage, usually 3-6 months post-operatively. Chronic post-operative pain syndrome of any magnitude usually involves 19-57% of patients that have undergone any kind of surgical procedure, while 5% of them experience intense symptoms. Risk factors for developing post-mastectomy pain syndrome include younger age, increased Body mass Index (BMI), psychological profile, co-existence of other painful conditions, pre-operative radiotherapy/chemotherapy, type of surgical procedure and anaesthesia, persistent acute postoperative pain, etc. Consequently, chronic post mastectomy pain syndrome results in significant psychosomatic sequelae with variable social impacts for the female patients.

The aim of the present study will be to investigate the incidence of chronic pain following breast cancer surgery in Cyprus, discover its associated risk factors and explore the impact of Pecs Blocks on the appearance of post mastectomy chronic pain symptoms.

During the preoperative visit, the women will be informed about the study and will be instructed to the use of the pain numeric rating scale (NRS) graded from 0 to 10. Standardized anesthesia will be administered. All patients will receive 1000 mg of paracetamol and 0.07 mg/ Kg of morphine intraoperatively. In the Post-Anesthesia Care Unit (PACU), patients will receive additional morphine boluses on request, until NRS score is lesser or equal than 4. Postoperative nausea and vomiting will be treated with ondansetron 4 mg iv. After discharge from PACU, patients will receive a combination of paracetamol 1 gr/6h and im pethidine 75 mg on request, as per hospital protocol.

Numerical rating scores (NRS) at rest and movement will be measured at 6h, 12h and 24h postoperatively. Additionally, the time to first request for analgesia after surgery will be noted.

All patients will also be evaluated 3 and 6 months after surgery with the use of NRS at rest and movement and additionally, via the use of Douleur Neuropathique (DN4) questionnaire for the occurence of neuropathic pain.

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-14
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-05
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

• American Society of Anesthesiologists (ASA) I-III patients
• Breast cancer patients
• Patients who receive operative treatment

Exclusion Criteria

• inability to consent to the study due to language barriers or cognitive dysfunction -
• skin infection at the puncture site
• contraindication to paracetamol administration
• known previous hepatic or renal impairment as assessed by the patients' history and routine biochemical markers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	no Pecs block	no regional block will be performed
study group	Pecs block	Pecs block under real-time ultrasound guidance after anesthesia induction will be performed. In specific, using the in-plane insertion technique, after visualization of the entire needle as a bright hyperechoic line and aiming between pectoralis major and pectoralis minor at the 3rd rib level, 2 ml of normal saline 09% will be injected first, to verify the correct position of the needle. Followingly, 10 mL ropivacaine 0.5% will be injected in order to block the lateral and medial pectoral nerves. Finally, another 15 ml of ropivacaine 0.5% plus 4 mg of dexamethasone will be injected between the pectoralis minor muscle and the anterior serratus muscle,at the level of the 4th and 5th ribs, after negative aspiration, to block the intercostal and intercostobrachial nerves. Using the color Doppler the vessels will be identified, so that their puncture is avoided during the procedures.

Primary Outcome Measures

Name	Time	Method
pain score 6 hours postoperatively	6 hours after surgery	pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 24 hours postoperatively	24 hours after surgery	pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 12 hours postoperatively	12 hours after surgery	pain score by the use of Numeric Rating Scale (NRS) 12 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

Secondary Outcome Measures

Name	Time	Method
satisfaction from postoperative analgesia	24 hours postoperatively	satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction
Pecs block related complications	48 hours postoperatively	Pecs block-related complications at the site of the local anesthetic injection
analgesic consumption in mg of morphine	24 hours postoperatively	additional analgesic consumption in the first 24 hours after the operation
time of first request for analgesia	24 hours postoperatively	time of first request for analgesia after the operation
incidence of chronic pain	6 months after surgery	occurrence of chronic pain at the site of the operation 6 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement

Trial Locations

Locations (3)

General Hospital of Nicosia; 🇨🇾 Nicosia, Cyprus

Aretaieion University Hospital; 🇬🇷 Athens, Greece

General Hospital of Limassol; 🇨🇾 Limassol, Cyprus