- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02645474
Is PECS Block Equivalent to Paravertebral Block in Preventing Postoperative Pain After Breast Surgery?
Is PECS Block Equivalent to Paravertebral Block in Preventing Postoperative Pain After Breast Surgery? A Randomized, Controlled, Double-blind, Multicenter Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim of the study is to compare paravertebral block and PECS block success rate in patients undergoing elective breast surgery (mastectomy or quadrantectomy) with a combined anesthesia technique.
Primary outcome is block success rate defined as a VAS score of 30 or less in PACU and at 6, 12 and 24 hours after surgery. Secondary outcomes are: rescue opioids requirement; incidence of procedure related complications; incidence of postoperative side-effects; patients' quality of life level during the first 24 postoperative hours; patients' satisfaction.
A prospective, randomized, controlled, double-blinded, non-inferiority trial was designed in order to compare paravertebral block and PECS block with regard to block success over the first 24 hours postoperatively in patients undergoing mastectomy or quadrantectomy procedures with a combined anesthesia technique.
Inclusion criteria: adult patients, ASA class 1 to 3, scheduled for elective mastectomy or quadrantectomy. Exclusion criteria: patients refusal, contraindication to regional anaesthesia (coagulopathies, concurrent anticoagulant therapy, allergy to local anaesthetics, infection at puncture site).
After written informed consent, patients will be randomized into two cohorts, the first being treated with a paravertebral block, while the second with a PECS block. Both procedures will be standardized with regard to injection technique, local anaesthetic drug and volume and performed under ultrasound real-time guidance. Both groups will undergo the regional anesthesia technique after induction of general anaesthesia to be blinded with regard to the type of block. This will be standardized as well, according to our centers current clinical practice. Postoperative pain will be than measured on a validated visual analogue scale (VAS 0-100) in the recovery room and periodically after discharge to the ward until 24 hours postoperatively. Rescue opioids requirement will be recorded. Eventual procedural complications occurred will be recorded as well as postoperative side effects. A questionnaire about patients' satisfaction and quality of life during the first 24 postoperative hours will be filled in for every patient. Data collected will be initially inserted in a form and subsequently collected, pooled and anonymously registered in an electronic data base.
A sample size calculation has been preliminary performed with regard to the primary outcome. A 20% difference in the blocks success rate (defined as a postoperative pain on VAS scale of 30 or less) will be considered as clinically significant.
In our practice, paravertebral block is the current gold standard and it is associated on average to a 50% mean value on VAS scale during the first 48 postoperative hours. PECS block will be thus compared to this standard of care. A total of 39 patients per arm will be required (95% confidence interval). Accounting for a 10% drop-out rate, we will include 43 patients per arm.
Pain levels will be measured as medians and interquartile ranges. Statistical analysis will be performed using Student t-test for normally distributed variables while Mann-Whitney test was applied to non-normally distributed variables.
This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP or ISO EN 14155 (as far as applicable) as well as all national legal and regulatory requirements.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Andrea Saporito, MD
- Phone Number: +41 (0)918118978
- Email: andrea.saporito@eoc.ch
Study Contact Backup
- Name: Luciano Anselmi, MD
- Phone Number: +41 (0)918118067
- Email: luciano.anselmi@eoc.ch
Study Locations
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-
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Bellinzona, Switzerland, 6500
- Recruiting
- Ospedale Regionale di Bellinzona e Valli
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Contact:
- Andrea Saporito, MD
- Phone Number: +41918118978
- Email: andrea.saporito@eoc.ch
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adult patients
- ASA class 1 to 3 patients
- patients scheduled for elective breast mastectomy or quadrantectomy
Exclusion Criteria:
- patients' refusal
- contraindication to regional anaesthesia (coagulopathies, concurrent anticoagulant therapy, allergy to local anaesthetics, infection at puncture site)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Paravertebral block with ropivacaine
Patients are treated with an older technique (paravertebral block with ropivacaine), somehow established in treating pain after breast surgery.
This technique has been shown to be effective but has an intrinsic risk of iatrogenic pneumothorax and is considered technically demanding.
|
Local anesthetic (ropivacaine 0.5%, total volume 20 ml) is infiltrated in the paravertebral block at T4 level under ultrasound guidance.
Other Names:
Amidic local anesthetic standardly used for nerve block and infiltration
Other Names:
|
EXPERIMENTAL: PECS block with ropivacaine
Patients are treated with PECS block, which has been already adopted in common clinical practice as an alternative to paravertebral block for postoperative pain treatment after breast surgery.
This technique is thought to be somehow simpler to perform and safer with regard to pneumothorax, however no studies have been done yet to statistically compare the two blocks with regard to safety and effectiveness.
|
Amidic local anesthetic standardly used for nerve block and infiltration
Other Names:
Local anesthetic (ropivacaine 0.5%, total volume 30 ml) is infiltrated in between the fasciae of serratus and minor pectoralis muscles under ultrasound guidance.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success rate (measured via visual analogue scale)
Time Frame: 24 hours after surgery
|
Changes in postoperative pain level of intensity over time will be measured via visual analogue scale (on a 0 to 100 scale, where 0 means no pain and 100 stands for the maximum pain ever experienced).
Patients in both groups will be asked to rate their postoperative pain levels at fixed intervals, i.e. in the postoperative anesthesia care unit and once in the ward at 6, 12, 24 hours after surgery
|
24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety (incidence of complications)
Time Frame: 24 hours after surgery
|
Safety will be assessed as incidence of complications in the two groups over the first 24hours.
Complications monitored will be: clinical signs of pneumothorax, inadvertent vascular puncture, local anesthetic toxicity
|
24 hours after surgery
|
Patients' satisfaction (subjective perception of the experience on a 0 to 100 scale)
Time Frame: 24 hours after surgery
|
Patients will be asked to rate their satisfaction with regard to procedural pain and subjective perception of the experience on a 0 to 100 scale
|
24 hours after surgery
|
Collaborators and Investigators
Investigators
- Study Chair: Luciano Anselmi, MD, Ospedale Regionale di Bellinzona e Valli
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PECS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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