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Completed

NCT Number: NCT04586751

The Impact of Pecs Blocks on Postmastectomy Pain Syndrome

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PECS block

Other

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

no Pecs block

Other

no regional block will be performed in this arm

Primary outcomes

  1. pain score 6 hours postoperatively

    Time frame: 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"

  2. pain score 12 hours postoperatively

    Time frame: 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"

  3. pain score 24 hours postoperatively

    Time frame: 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"

Secondary outcomes

  1. incidence of chronic pain

    Time frame: 3 months after surgery

    occurrence of chronic pain at the site of the operation 3 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement

  2. incidence of chronic pain

    Time frame: 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

  3. time of first request for analgesia

    Time frame: 24 hours postoperatively

    time of first request for analgesia after the operation

  4. analgesic consumption in mg of morphine

    Time frame: 24 hours postoperatively

    additional analgesic consumption in the first 24 hours after the operation

  5. satisfaction from postoperative analgesia

    Time frame: 24 hours postoperatively

    satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction

  6. Pecs block related complications

    Time frame: 48 hours postoperatively

    Pecs block-related complications at the site of the local anesthetic injection

Sponsors and collaborators

Lead sponsor

Aretaieion University Hospital

Other

Registry information

Official study title

The Impact of Pecs Blocks on the Appearance of Post Mastectomy Chronic Pain Symptoms

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2020
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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