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

Sponsor

GZA Ziekenhuizen Campus Sint-Augustinus (Other)

Overall Status

Completed

CT.gov ID

NCT02544282

Collaborator

(none)

140

Enrollment

Location

Arms

Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Postoperative Nausea and Vomiting	Drug: Levobupivacaine Drug: NaCl 0.9% Drug: Sevoflurane Drug: Propofol Drug: Sufentanil Drug: Atracurium Drug: Paracetamol Drug: Tramadol Drug: Piritramide	Phase 4

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pecs II General anesthesia followed by a Pecs II block and opioids if required	Drug: Levobupivacaine Pecs II Block Other Names: Chirocaine Drug: Sevoflurane General Anesthesia Drug: Propofol General Anesthesia Drug: Sufentanil General Anesthesia Drug: Atracurium General Anesthesia Drug: Paracetamol Pain Relief Other Names: Acetaminophen Drug: Tramadol Pain Relief Drug: Piritramide Pain Relief
Placebo Comparator: Placebo General anesthesia followed by a placebo Pecs II block and opioids if required	Drug: NaCl 0.9% Placebo Pecs II block Other Names: Normal Saline Drug: Sevoflurane General Anesthesia Drug: Propofol General Anesthesia Drug: Sufentanil General Anesthesia Drug: Atracurium General Anesthesia Drug: Paracetamol Pain Relief Other Names: Acetaminophen Drug: Tramadol Pain Relief Drug: Piritramide Pain Relief

Arm

Intervention/Treatment

Active Comparator: Pecs II

General anesthesia followed by a Pecs II block and opioids if required

Drug: Levobupivacaine

Pecs II Block

Other Names:

Chirocaine

Drug: Sevoflurane

General Anesthesia

Drug: Propofol

General Anesthesia

Drug: Sufentanil

General Anesthesia

Drug: Atracurium

General Anesthesia

Drug: Paracetamol

Pain Relief

Other Names:

Acetaminophen

Drug: Tramadol

Pain Relief

Drug: Piritramide

Pain Relief

Placebo Comparator: Placebo

General anesthesia followed by a placebo Pecs II block and opioids if required

Drug: NaCl 0.9%

Placebo Pecs II block

Other Names:

Normal Saline

Drug: Sevoflurane

General Anesthesia

Drug: Propofol

General Anesthesia

Drug: Sufentanil

General Anesthesia

Drug: Atracurium

General Anesthesia

Drug: Paracetamol

Pain Relief

Other Names:

Acetaminophen

Drug: Tramadol

Pain Relief

Drug: Piritramide

Pain Relief

Outcome Measures

Primary Outcome Measures

Postoperative Pain [up to 72 hours after completion of surgery]
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

Secondary Outcome Measures

Peroperative Opioid Consumption [Peroperative period (max. 5 hours)]
Anesthetist in charge reports Opioid Consumption. Master data set is administrated by secretarial office of Anesthesia department
Postoperative Opioid Consumption [up to 72 hours after completion of surgery]
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
Postoperative Nausea and Vomiting [up to 72 hours after completion of surgery]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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