- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04474366
The Effect of Pectoral Blocks on Perioperative Pain in Gender Affirmation Top Surgery
The Effect of Pectoral Blocks on Perioperative Pain in Simple Mastectomy and Breast Reduction in Gender Affirmation Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All participants will be seen in clinic with the attending surgeon anywhere from two weeks to a few months prior to the date of surgery. Participants will also have a pre-op visit with anesthesia a few weeks before surgery. They will undergo a standard anesthesia preoperative evaluation, which will include a medical chart review, physical exam, and appropriate laboratory studies. The preoperative evaluation will be identical for those participating in the study and those who do not. If no contraindications to the Pectoralis Nerve Block (PECS I and II block) are identified by the surgeon and/or anesthesiologist, participants will be approved to participate. The participants will be introduced to the study either during their clinic visit prior to surgery or over the telephone a few days prior to surgery. All questions will be answered by one of the study investigators. A study consent will be obtained from the participants and they will then will be randomized into either control (sham block) or experimental (PECS I and II block) group.
On the day of surgery, as per standard of care, each participant will undergo a general anesthetic in the same manner with conventional perioperative management. During induction of anesthesia, up to 2mg of midazolam and/or up to 100mcg of fentanyl will be given. The above protocol will be followed regardless of study participation and study group (if participating). After induction of anesthesia, the nerve blocks, or control blocks, will be performed. The regional anesthesia team will be involved in all patients, whether in the control or intervention group. All patients will be come and go regardless of group.
Group 1 (control) will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally.
Group 2 (treatment) will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally. (Not to exceed 225mg or 3.5mg/kg).
PECS I and II Block Technique: Performed in the supine position with the arms abducted 90 degrees at the shoulder. Using an ultrasound transducer in the parasagittal plane, the axillary artery and vein are identified just inferior to clavicle and medial to coracoid process. Additionally, the 2nd rib is identified and the transducer is slid inferiorly until the 3rd and 4th rib are identified. At this point the pectoralis major, minor, and serratus anterior muscles are seen. Then the block needle is inserted through the skin and advanced into the fascial plane between pectoralis minor and serratus anterior muscles. After negative aspiration, the anesthetic is injected into the plane watching for hydrodissection of the muscles. A total volume of 20ml is injected. Then the needed is withdrawn until the tip is located in the fascial plane between the pectoralis major and minor muscles. 10ml of anesthetic is injected into this plane.
General anesthesia is maintained in the standard fashion. The anesthesiologist will administer Fentanyl as he or she feels necessary during the operation. Post operatively, in the PACU, participants will be given IV hydromorphone as needed for pain. Pain scales will be documented at set time points post operatively and participants will be given pain diaries to document these pain scores as well as their opioid consumption. All patients will be sent home with a prescription for 20 tablets of Norco 5mg/325mg. Participants will be asked to document their pain scores at the following post op time points: 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 1 week. Participants will return their pain diaries at the 1 week post operative visit. This visit is a standard of care follow up visit.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California, San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) class I-III
- Ages 18-65
- Undergoing gender confirmation breast reduction surgery by a single surgeon at a single center
Exclusion Criteria:
- Previous breast surgeries
- Current breast cancer or history of treatment for breast cancer
- Current chronic pain syndromes
- Coagulopathy
- Allergy to local anesthetics
- Infection at the injection site
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Saline
Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally.
|
Saline injection as sham block in identical fashion as Pectoralis Nerve Block
|
Experimental: Ropivacaine
Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg).
|
Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Post Operative Pain Scores
Time Frame: 1 week post operative
|
Participant recorded Numerical Rating Scale (NRS) pain scores post operatively.
Scale ranges from 0 to 10. 0 represents no pain at all. 10 represents most severe pain.
|
1 week post operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Intra Operative Narcotic Requirements
Time Frame: Intraoperative
|
Intraoperative narcotic administration will be compared.
Narcotic administration will be acquired through chart review.
Total dose of IV hydromorphone intraoperatively will be collected.
|
Intraoperative
|
Comparison of Post Operative Narcotic Requirements
Time Frame: 1 week post operative
|
Self reported narcotic intake postoperatively.
Number of pills taken will be recorded.
Each group's number of pills will be averaged.
|
1 week post operative
|
Collaborators and Investigators
Investigators
- Principal Investigator: Esther Kim, MD, University of California, San Francisco
Publications and helpful links
General Publications
- Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
- M N, Pandey RK, Sharma A, Darlong V, Punj J, Sinha R, Singh PM, Hamshi N, Garg R, Chandralekha C, Srivastava A. Pectoral nerve blocks to improve analgesia after breast cancer surgery: A prospective, randomized and controlled trial. J Clin Anesth. 2018 Mar;45:12-17. doi: 10.1016/j.jclinane.2017.11.027. Epub 2017 Dec 11.
- Benotsch EG, Zimmerman R, Cathers L, McNulty S, Pierce J, Heck T, Perrin PB, Snipes D. Non-medical use of prescription drugs, polysubstance use, and mental health in transgender adults. Drug Alcohol Depend. 2013 Sep 1;132(1-2):391-4. doi: 10.1016/j.drugalcdep.2013.02.027. Epub 2013 Mar 17.
- Day JK, Fish JN, Perez-Brumer A, Hatzenbuehler ML, Russell ST. Transgender Youth Substance Use Disparities: Results From a Population-Based Sample. J Adolesc Health. 2017 Dec;61(6):729-735. doi: 10.1016/j.jadohealth.2017.06.024. Epub 2017 Sep 21.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- Mental Disorders
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Sexual Dysfunctions, Psychological
- Pain, Postoperative
- Gender Dysphoria
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Ropivacaine
Other Study ID Numbers
- 19-28267
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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 Pain, Postoperative
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
Clinical Trials on Saline (0.9%)
-
Tri-Service General HospitalCompleted
-
University of California, DavisEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedDiabetic Ketoacidosis | Cerebral EdemaUnited States
-
Vanderbilt University Medical CenterActive, not recruitingPostural Tachycardia SyndromeUnited States
-
University of MalayaUnknown
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | Coronary Disease | Neurologic ManifestationsUnited States
-
Santaris Pharma A/SCompleted
-
Rigshospitalet, DenmarkCompleted
-
Ann & Robert H Lurie Children's Hospital of ChicagoWithdrawn
-
University Hospital Inselspital, BerneCompletedCardiovascular Diseases | Valvular Heart DiseaseSwitzerland
-
CSL BehringTerminatedOral MucositisUnited States, Canada, Australia, Germany, Italy, Austria