Serratus Plane Block for Postoperative Pain Control

Augmentation Clinical Trial

Official title:

Serratus Plane Block for Postoperative Pain Control After Breast Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02865928
• Other study ID #: 15-246
• Status: Terminated
• Phase: Phase 4
• Start date: September 5, 2017
• Est. completion date: November 25, 2019

Study information

• Verified date: February 2024
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: November 25, 2019
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Augmentation
• Mastopexy
• Outpatient Breast Surgery
• Pain, Postoperative
• Revision

Intervention

Drug:
• Bupivicaine HCl
Ultrasound guided serratus plane block with bupivicaine
• Normal Saline
Same injection technique as intervention arm with normal saline

Locations

Country	Name	City	State
United States	Northwell Health System	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Opioid Requirements	Postoperatively, oral and IV rescue medication will be administered to both groups upon request as per standard of care. The use of narcotics will also be recorded intra-operatively, for the duration of PACU and hospital stay and up until the end of postoperative day one. Consumption of rescue medication will be converted to the morphine equivalent (ME) dose for analysis.	4 to 10 hours
Secondary	Postoperative Pain With Numeric Rating Scale	Postoperatively, pain intensities at rest and on movement will be assessed every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, using the visual analog scale (VAS) with two anchor points; 0 being no pain and 10 being the worst pain imaginable. Pain scores were combined to find the mean and standard deviation.; The study will collect pain and scores in the PACU every 30 minutes up to 4 hrs and at 1 hr intervals after 4 hours for the duration of PACU stay.	every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours.
Secondary	Postoperative Nausea and Vomiting With Verbal Rating Scale	Nausea assessed at time intervals with numeric rating scale and episodes of vomiting and retching recorded.; Evaluation will be performed at every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge using a standard 11-point verbal rating scale, for which "0" represents "no nausea" and 10 represents "worst nausea imaginable." Nausea and vomiting scores were combined to find the mean and standard deviation.; The study will collect nausea and scores in the PACU every 30 minutes up to 4 hrs and at 1 hr intervals after 4 hours for the duration of PACU stay.	every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours.
Secondary	Number of Participants Who Required Antiemetics During the Postoperative Period.	Number of Participants who Required Antiemetics During the Postoperative Period.	4 to 10 hours
Secondary	PACU Length of Stay	Time to PACU discharge	0 to 10 hours
Secondary	Patient Experience and Satisfaction With a 5-point Categorial Scale	This survey assessed patient experience and satisfaction. The scale ranged from "Very dissatisfied" or "1" was the minimum value. "Very satisfied" or "5" was the maximum value.	1 week