Serratus Plane Block for Postoperative Pain Control

NCT ID: NCT02865928

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-05
• Study Completion Date: 2019-11-25

Brief Summary

This is a randomized, double-blinded, placebo-controlled trial of serratus plane blocks in subjects undergoing outpatient unilateral or bilateral breast surgery. Ninety subjects will be enrolled into the study at presurgical testing. Subjects will be stratified based on surgery type and randomized to receive a serratus plane block with either bupivicaine HCL or placebo. All patients will receive standard intraoperative anesthesia and standard postoperative pain control. The primary endpoint is the amount of opioid administered postoperatively. Secondary endpoints include postoperative pain intensity at timed intervals, amount of opioid administered intraoperatively and postoperatively, incidence of nausea and vomiting, time to discharge and patient satisfaction

Conditions

Outpatient Breast Surgery; Mastopexy; Augmentation; Revision

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bupivicaine HCl

Ultrasound guided serratus plane block with bupivacaine HCl.

Group Type: EXPERIMENTAL

Bupivicaine HCl

Intervention Type: DRUG

Ultrasound guided serratus plane block with bupivicaine

Normal Saline

Placebo injection on operated side, same technique as experimental group.

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Same injection technique as intervention arm with normal saline

Interventions

Bupivicaine HCl

Ultrasound guided serratus plane block with bupivicaine

Intervention Type: DRUG

Normal Saline

Same injection technique as intervention arm with normal saline

Intervention Type: DRUG

Other Intervention Names

Bupivicaine; 0.09% NaCl

Eligibility Criteria

Inclusion Criteria

• ASA I-III.
• Undergoing outpatient breast surgery requiring general anesthesia, including but not limited to mastectomy, lumpectomy, reconstruction with tissue expanders or implants and reconstruction revision.

Exclusion Criteria

• Unable to provide informed consent.
• Patients who are pregnant or nursing.
• ASA IV-V.
• Alcohol or narcotic dependence in the last 2 years.
• Concurrent condition requiring regular use of analgesia that may confound post-surgical assessments as determined by principle investigator.
• Hepatic disease.
• Allergies to amide anesthetics as determined from medical history or patient self-report.
• Evidence of infection at injection site.
• Contraindication to pain medications such as acetominophen, morphine, oxycodone, keterolac, dilaudid, Toradol.
• Body weight <50kg.
• BMI>40kg/m2.
• History of hypotension.
• Abnormal renal (creatinine > 1.5 mg/dL) function.
• Heart block.
• Any physical, mental or medical condition, that in the opinion of the investigator, makes study participation inadvisable.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Judith Aronsohn, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judith Aronsohn, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Northwell Health System

New Hyde Park, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

15-246

Identifier Type: -

Identifier Source: org_study_id