Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery

Pain, Postoperative Clinical Trial

Official title:

Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery: Effect on Postoperative Pain and Opioid Consumption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02544282
• Other study ID #: GZA-ANE-PECS-01
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2015
• Last updated: July 12, 2016
• Start date: April 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2015
• Source: GZA Ziekenhuizen Campus Sint-Augustinus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

In this prospective trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with axillary node dissection will be randomly assigned to general anesthesia with opioids combined with a Pecs II block or to general anesthesia with opioids combined with a placebo Pecs II block. Participants will be followed postoperatively during their entire hospital stay to determine the effectiveness of Pecs II block and opioids versus placebo Pecs II block and opioids as postoperative pain treatment.

Description:

Each year, 9400 new cases of breast cancer are diagnosed in Belgium. It makes breast cancer the most common cancer in women, good for more than one third of all cancer cases in women.

Surgical excision of the tumour is a necessary and effective step to cure from the disease. Recent studies have demonstrated the positive effects of regional anesthesia on peroperative and postoperative pain. Paravertebral blocks have become popular as an alternative to the analgesia provided by the 'gold standard' of thoracic epidural analgesia. However, both regional techniques have complications and slow learning curves that make them unsuitable for the large proportion of breast surgery patients who are treated on a day-stay basis. Recently, Rafael Blanco introduced the Pecs and Pecs II blocks, a practical alternative to both paravertebral and epidural blockade in the management of pain after breast surgery.

The investigators introduced the Pecs II block in their clinical practice. This study compares general anesthesia with a Pecs II block to general anesthesia with a placebo Pecs II block for breast surgery. The objective is to evaluate analgesic effectiveness and changes in opioid consumption when applying a Pecs II block versus a placebo Pecs II block.

Stage 1-3 patients having mastectomies or tumourectomies with axillary clearance will be randomly assigned to general anesthesia with a Pecs II block or to general anesthesia with a placebo Pecs II block. Enrolling 140 patients over an anticipated time frame of 2 years will provide an 90% power and a p-value of 0.05 for perioperative and postoperative opioid consumption as well as pain scores (NRS). Confirming the hypothesis will indicate that a minor modification to the anesthetic procedure will reduce the opioid consumption (including it's unwanted side effects) during and after surgery while maintaining or reducing patients' indicated pain scores (NRS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Primary breast cancer without known extension beyond the breast and axillary nodes (i.e. believed to be Tumor Stage 1-3, Nodes 0-2)

• Scheduled for unilateral or bilateral mastectomy with or without implant (isolated "lumpectomy" will not qualify)

• Isolated "lumpectomy" with axillary node dissection (anticipated removal of at least five nodes)

• Written informed consent, including willingness to be randomized to opioids or regional analgesia

• Dutch speaking

Exclusion Criteria:

• Previous surgery for breast cancer (except diagnostic biopsies)

• Inflammatory breast cancer

• Scheduled free flap reconstruction

• ASA Physical Status = 4

• Any contraindication to locoregional analgesia (including coagulopathy, abnormal anatomy)

• Any contraindication to midazolam, propofol, sevoflurane, sufentanyl, tramadol or piritramide

• Other cancer not believed by the attending surgeon to be in long-term remission

• Systemic disease believed by the attending surgeon to present = 25% two-year mortality

• Obesity defined as BMI = 30 kg/m2

• Chronic use of pain medication (started > 3 months ago)

• Allergic to Chirocaine

• Chronic drug or alcohol abuse

• INR > 1.4

• Thrombocytopenia < 70,000 platelets

• Dementia

• Pregnancy

• Kidney or liver failure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Levobupivacaine
Pecs II Block
• NaCl 0.9%
Placebo Pecs II block
• Sevoflurane
General Anesthesia
• Propofol
General Anesthesia
• Sufentanil
General Anesthesia
• Atracurium
General Anesthesia
• Paracetamol
Pain Relief
• Tramadol
Pain Relief
• Piritramide
Pain Relief

Locations

Country	Name	City	State
Belgium	GZA Sint Augustinus	Wilrijk	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
GZA Ziekenhuizen Campus Sint-Augustinus

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain	Within first hour: Each ten minutes by Recovery Nurse. Hour 2 till discharge ( max 72 hours post surgery): hourly by patient through questionnaire.Master data set is administrated by secretarial office of Anesthesia departement	up to 72 hours after completion of surgery	No
Secondary	Peroperative Opioid Consumption	Anesthetist in charge reports Opioid Consumption. Master data set is administrated by secretarial office of Anesthesia department	Peroperative period (max. 5 hours)	No
Secondary	Postoperative Opioid Consumption	Nurse of postoperative recovery room and nurse of ward in charge reports opioid consumption on patient questionnaire. Master data set is administrated by secretarial office of Anesthesia department	up to 72 hours after completion of surgery	No
Secondary	Postoperative Nausea and Vomiting	Nurse of postoperative recovery room and nurse of ward in charge reports patients nausea and vomiting as well as the administered medication against postoperative nausea and vomiting on patient questionnaire. Master data set is administrated by secretarial office of Anesthesia department	up to 72 hours after completion of surgery	No