- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02865265
Pecs II Block and PaB Could be an Alternative in Breast Surgery
Association Between Ultrasound-guided Pecs II Block and Parasternal Block May Represent a Valid Alternative for the Management of Acute and Postoperative Pain Syndrome in Breast Cancer Surgery: a Retrospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18-75 years of age;
- American Society of Anesthesiologists (ASA) physical status I-III,
- patients scheduled for quadrantectomy with or without axillary dissection
Exclusion Criteria:
- pregnancy;
- body mass index (BMI) >35;
- allergy to local anesthetics;
- skeletal or muscle abnormalities of the chest wall;
- presence of primary or secondary neurological diseases;
- presence of psychiatric diseases;
- history of chronic pain or neuropathic disorders;
- history of drug abuse;
- state of sepsis;
- infection
- tumors of the skin on the chest;
- primary;
- secondary coagulopathies
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pecs II and parasternal blocks
Pecs II block was performed at the level of the fourth rib in the fascial plane between the minor pectoral and serratus anterior muscles, and 20 ml of 0.5% levobupivacaine solution were injected. An ultrasound-guided ipsilateral PaB was performed via two separate injections of 4 ml of 0.375% levobupivacaine at the level of the 2nd and 4th intercostal space underneath the external intercostal membrane between the major pectoral and intercostal muscles close to the surface of the 2nd and 4th rib. |
Pecs II block was performed at the level of the fourth rib in the fascial plane between the minor pectoral and serratus anterior muscles, and 20 ml of 0.5% levobupivacaine solution were injected. An ultrasound-guided ipsilateral parasternal block was performed via two separate injections of 4 ml of 0.375% levobupivacaine at the level of the 2nd and 4th intercostal space underneath the external intercostal membrane between the major pectoral and intercostal muscles close to the surface of the 2nd and 4th rib. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: Pain was recorded at 24 months after surgery
|
Pain has been evaluate with visual analogue scale (VAS) at 24 months after surgery
|
Pain was recorded at 24 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropathic postoperative disturbances
Time Frame: Neuropathic postoperative disturbances were recorded at 24 months after surgery
|
Neuropathic postoperative disturbances were examined using the von Frey hair test (neuropathic disturbances: present/not present) at 24 months
|
Neuropathic postoperative disturbances were recorded at 24 months after surgery
|
Patient satisfaction
Time Frame: Patient satisfaction was evaluated at 1 day after surgery
|
Patient satisfaction with regard to the anesthetic procedure was assessed using a five-step satisfaction scale (not at all/slightly/somewhat/very/extremely satisfied).
|
Patient satisfaction was evaluated at 1 day after surgery
|
Woud healing
Time Frame: Wound healing was assessed at 24 months after surgery
|
Wound healing was assessed using a three-step scale (unacceptable/acceptable/excellent healing) in accordance with the surgeon's opinion.
|
Wound healing was assessed at 24 months after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0109060/16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
Clinical Trials on Pecs II and parasternal blocks
-
San Salvatore Hospital of L'AquilaCompleted
-
San Salvatore Hospital of L'AquilaCompleted
-
Assiut UniversityCompletedBreast Cancer | Acute Postoperative PainEgypt
-
Ain Shams UniversityCompleted
-
Mansoura UniversityUnknownPost Mastectomy Pain Syndrome | After Breast Surgery
-
Jewish General HospitalActive, not recruitingCoronary Artery Bypass Graft SurgeryCanada
-
Charite University, Berlin, GermanyDeutsche KinderkrebsstiftungCompletedLymphoma, Non-Hodgkin | Lymphoblastic Leukemia, AcuteGermany
-
Northwestern UniversityPacira Pharmaceuticals, IncRecruitingMammaplastyUnited States
-
Carmel Medical CenterUnknown
-
Melinda SeeringCompletedBreast Cancer | Postoperative Pain | Anesthesia | Nerve BlockUnited States