The Impact of Pecs Blocks on Postmastectomy Pain Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Pain Syndrome Pain, Postoperative Chronic Pain Breast Cancer Breast Soft Tissue Neoplasm Breast Neoplasms Breast Cancer Female Breast Pain Anesthesia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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study group

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.

Group Type ACTIVE_COMPARATOR

Pecs block

Intervention Type OTHER

Pecs block under real-time ultrasound guidance after anesthesia induction will be performed.

control group

no regional block will be performed

Group Type SHAM_COMPARATOR

no Pecs block

Intervention Type OTHER

no regional block will be performed in this arm

Interventions

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Pecs block

Pecs block under real-time ultrasound guidance after anesthesia induction will be performed.

Intervention Type OTHER

no Pecs block

no regional block will be performed in this arm

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No