• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

SAGES

Reimagining surgical care for a healthier world

  • Home
    • COVID-19 Annoucements
    • Search
    • SAGES Home
    • SAGES Foundation Home
  • About
    • Who is SAGES?
    • SAGES Mission Statement
    • Advocacy
    • Strategic Plan, 2020-2023
    • Committees
      • Request to Join a SAGES Committee
      • SAGES Board of Governors
      • Officers and Representatives of the Society
      • Committee Chairs and Co-Chairs
      • Full Committee Rosters
      • SAGES Past Presidents
    • Donate to the SAGES Foundation
    • Awards
      • George Berci Award
      • Pioneer in Surgical Endoscopy
      • Excellence In Clinical Care
      • International Ambassador
      • IRCAD Visiting Fellowship
      • Social Justice and Health Equity
      • Excellence in Community Surgery
      • Distinguished Service
      • Early Career Researcher
      • Researcher in Training
      • Jeff Ponsky Master Educator
      • Excellence in Medical Leadership
      • Barbara Berci Memorial Award
      • Brandeis Scholarship
      • Advocacy Summit
      • RAFT Annual Meeting Abstract Contest and Awards
  • Meetings
    • NBT Innovation Weekend
    • SAGES Annual Meeting
      • 2023 Scientific Session Call For Abstracts
      • 2023 Emerging Technology Call For Abstracts
    • CME Claim Form
    • Industry
      • Advertising Opportunities
      • Exhibit Opportunities
      • Sponsorship Opportunities
    • Future Meetings
    • Past Meetings
      • SAGES 2022
      • SAGES 2021
    • Related Meetings Calendar
  • Join SAGES!
    • Membership Benefits
    • Membership Applications
      • Active Membership
      • Affiliate Membership
      • Associate Active Membership
      • Candidate Membership
      • International Membership
      • Medical Student Membership
    • Member News
      • Member Spotlight
      • Give the Gift of SAGES Membership
  • Patients
    • Healthy Sooner – Patient Information for Minimally Invasive Surgery
    • Patient Information Brochures
    • Choosing Wisely – An Initiative of the ABIM Foundation
    • All in the Recovery: Colorectal Cancer Alliance
    • Find a SAGES Member
  • Publications
    • SAGES Stories Podcast
    • SAGES Clinical / Practice / Training Guidelines, Statements, and Standards of Practice
    • Patient Information Brochures
    • TAVAC – Technology and Value Assessments
    • Surgical Endoscopy and Other Journal Information
    • SAGES Manuals
    • SCOPE – The SAGES Newsletter
    • COVID-19 Annoucements
    • Troubleshooting Guides
  • Education
    • OpiVoid.org
    • SAGES.TV Video Library
    • Safe Cholecystectomy Program
      • Safe Cholecystectomy Didactic Modules
    • Masters Program
      • SAGES Facebook Program Collaboratives
      • Acute Care Surgery
      • Bariatric
      • Biliary
      • Colorectal
      • Flexible Endoscopy (upper or lower)
      • Foregut
      • Hernia
      • Robotics
    • Educational Opportunities
    • HPB/Solid Organ Program
    • Courses for Residents
      • Advanced Courses
      • Basic Courses
    • Video Based Assessments (VBA)
    • Robotics Fellows Course
    • MIS Fellows Course
    • Facebook Livestreams
    • Free Webinars For Residents
    • SMART Enhanced Recovery Program
    • SAGES OR SAFETY Video
    • SAGES at Cine-Med
      • SAGES Top 21 MIS Procedures
      • SAGES Pearls
      • SAGES Flexible Endoscopy 101
      • SAGES Tips & Tricks of the Top 21
  • Opportunities
    • NEW-Area of Concentrated Training Seal (ACT)-Advanced Flexible Endoscopy-Coming Soon!
    • SAGES Fellowship Certification for Advanced GI MIS and Comprehensive Flexible Endoscopy
    • Multi-Society Foregut Fellowship Certification
    • SAGES Research Opportunities
    • Fundamentals of Laparoscopic Surgery
    • Fundamentals of Endoscopic Surgery
    • Fundamental Use of Surgical Energy
    • Job Board
    • SAGES Go Global: Global Affairs and Humanitarian Efforts
  • Search
    • Search All SAGES Content
    • Search SAGES Guidelines
    • Search the Video Library
    • Search the Image Library
    • Search the Abstracts Archive
  • Store
    • “Unofficial” Logo Products
  • Log In

A new method for treating POP associated with LS

Asok Doraiswamy, MD1, Jon Meisner, MD2, Neil Verity, PhD2. 1Huntington Memorial Hospital, Pasadena, CA, 2DURECT Corporation, Cupertino, CA

Objective

Despite improvements in analgesic techniques, insufficient postoperative pain control remains a significant problem, with a recent study reporting the presence of moderate to extreme pain after 79% of inpatient and 72% of outpatient surgeries.1 Opioid analgesics, though widely used for postoperative pain control, can cause undesirable side effects (most commonly nausea and vomiting, constipation, and sedation) that delay mobilization, demand more intensive postoperative care, and lower patient satisfaction. We sought to develop a sustained-release, locally-acting, non-opioid analgesic administered once at the close of surgery that could provide analgesic coverage for the entire 3-day postsurgical period during which pain is most intense.

Description

Sucrose acetate isobutyrate extended-release bupivacaine (SABER®-Bupivacaine) contains 660 mg of bupivacaine base in a single 5 mL dose. It is instilled directly into the laparoscopic port incision(s) in divided doses at the close of surgery with a blunt-tipped applicator. Once placed, it forms a viscous depot that releases bupivacaine at a stable rate of approximately 10 mg/h over 72 hours. In addition to bupivacaine, the SABER-Bupivacaine formulation contains sucrose acetate isobutyrate, a water-insoluble, biocompatible, biodegradable esterified sugar matrix capable of trapping bupivacaine at high concentrations, and benzyl alcohol, an antimicrobial solvent. A transparent semiviscous solution, SABER-Bupivacaine is stable for 3 years at room temperature.

Preliminary results

A randomized controlled double-blind study of 50 patients undergoing elective laparoscopic cholecystectomy compared SABER-Bupivacaine, instilled into the port incisions, with the active control bupivacaine HCl, infiltrated peri-incisionally. 30 patients in the intention-to-treat population received SABER-Bupivacaine 5 mL and 20 received bupivacaine HCl 0.5% 30 mL. Mean pain intensity on movement, measured on an 11-point, 0-10 numeric rating scale at 17 time points over the first 72 hours after surgery, was 25% lower in the SABER-Bupivacaine group than the bupivacaine HCl group (2.7 vs 3.6, P=0.024). A comparison of pain scores over time (Figure 1) showed the reduction in pain intensity was sustained over the entire 72-hour period. Median total opioid rescue medication use during this period was 24% lower in the SABER-bupivacaine group than the bupivacaine HCl group (17.0 vs 22.5 IV morphine mg equivalents, P=0.201). Plasma bupivacaine concentrations were well within established safety margins, and 72-hour Holter monitoring showed no evidence of cardiac arrhythmias. Treatment-related adverse event rates were similar between the 2 groups, with the exception of application site discoloration, which was more common among SABER-Bupivacaine-treated patients (23%) than bupivacaine-HCl treated patients (5%).

Conclusion and future directions

In this pilot study, SABER-Bupivacaine significantly reduced pain and nonsignificantly reduced opioid consumption for 72 hours postoperatively compared with bupivacaine HCl. A non-opioid, locally-acting analgesic instilled directly into the laparoscopic port incisions at the close of surgery, SABER-Bupivacaine may provide important benefits to patients undergoing inpatient or outpatient laparoscopic procedures. A multicenter, placebo-controlled, Phase 3 study of approximately 300 patients undergoing elective outpatient laparoscopic cholecystectomy began enrolling in late 2015 to test this hypothesis. Study completion is expected in about 1 year.

 

_________

1Gan TJ, et al. Curr Med Res Opin. 2014;30:149–160.

124

Share this:

  • Twitter
  • Facebook
  • LinkedIn
  • Pinterest
  • WhatsApp
  • Reddit

Related

« Return to SAGES 2016 abstract archive

Our Mission

Innovate, educate and collaborate to improve patient care.

Recently, on SAGES…

Critical View of Safety (CVS) Challenge QR Code

The SAGES Critical View of Safety Challenge – Donate Your Lap Chole Videos!

The Society of American Gastrointestinal and Endoscopic Surgeons is hosting the first Artificial Intelligence Data Challenge conducted by surgeons. The aim of this challenge is to generate a large and diverse dataset of laparoscopic cholecystectomy videos, annotated with respect to the subcomponents of the Critical View of Safety (CVS). Computer scientists from all over the […]

Respuesta de SAGES al Estudio NordICC sobre el beneficio de las colonoscopias de detección

SAGES desea aclarar los resultados del estudio NordICC y colocarlos en contexto de los esfuerzos de varias agencias nacionales para reducir el riesgo de cáncer colorrectal – la segunda causa de muerte por cáncer más frecuente en los Estados Unidos-, mediante la promoción de la detección y tratamiento oportuno de las lesiones.

SAGES Response to NordICC Study Regarding Benefit of Screening Colonoscopies

The NordICC Study recently published in The New England Journal of Medicine and widely reported on by media outlets has raised questions regarding the benefit of screening colonoscopy in lowering the risk of colorectal cancer and cancer-related deaths among otherwise healthy and symptom-free men and women aged 55 to 64. Provocative headlines and commentaries have […]

Contact SAGES

Society of American Gastrointestinal and Endoscopic Surgeons
11300 W. Olympic Blvd Suite 600
Los Angeles, CA 90064 USA
webmaster@sages.org
Tel: (310) 437-0544

Find Us Around the Web!

  • Facebook
  • Twitter
  • YouTube

Important Links

SAGES 2023 Meeting Information

Healthy Sooner: Patient Information

SAGES Guidelines, Statements, & Standards of Practice

SAGES Manuals

 

  • taTME Study Info
  • Foundation
  • SAGES.TV
  • MyCME
  • Educational Activities

Copyright © 2023 Society of American Gastrointestinal and Endoscopic Surgeons