EXPAREL for Minimally Invasive Supracervical Hysterectomies

NCT03769714 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2018-02-12-MMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the of the study is a reduction in minimally invasive supracervical hysterectomy postsurgical pain, which may result in less need for supplemental opioid pain medications, fewer opioid related adverse events, and a better recovery experience for patients, which may offer an economic benefit to health care systems. Intracervical preoperative dose of Exparel during minimally invasive (robotic--assisted or traditional laparoscopy) supracervical hysterectomy reduces cumulative pain scores for up to 24 hours and reduces overall requests for break through (additional) analgesia with opioid consumption compared with placebo.

Conditions

Pain

Keywords

laparoscopy; supracervical hysterectomy; Multimodal pain management; bupivacaine liposome; Exparel

Outcome Measures

Primary Outcomes (2)

• Pain at 12 Hours

  Participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).at 12 hours postoperatively

  12 hours after surgery

• Pain at 48 Hours

  Participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).at 48 hours postoperatively

  48 hours after surgey

Study Arms (2)

Saline Solution for Injection

ACTIVE COMPARATOR

Group A (control, n=26) to receive 20ml of saline while prepping. The syringe will covered as to disguise the contents of the syringe.

Drug: Saline Solution for Injection

Exparel

EXPERIMENTAL

Group B (study, n=26) to receive 20ml of liposomal bupivacaine (EXPAREL) into the stroma of the cervix at the 4 and 8 o'clock positions (innervation insertion points of the cervix).

Drug: Exparel

Interventions

Saline Solution for Injection DRUG

Injection of 20mL of 0.9%Normal Saline

Also known as: Standard

Saline Solution for Injection

Exparel DRUG

Exparel (bupivacaine liposome injectable suspension) is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated (bupivacaine liposome injectable suspension) for administration into the surgical site to produce postsurgical analgesia.

Also known as: liposomal bupivicaine

Exparel

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age at the Screening Visit.
• Female subjects only.
• Scheduled to undergo minimally invasive (robotic-assisted or laparoscopic) supracervical hysterectomy, under general anesthesia.
• Clinical laboratory values less than twice the upper limit of normal or, if abnormal, deemed not clinically significant per the Investigator.
• Ability to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.

You may not qualify if:

• Currently pregnant, nursing, or planning to become pregnant.
• Use of any of the following medications within the times specified before surgery: a. opioid, SSRI, tricyclic antidepressant, gabapentin, pregabalin within three days of surgery. b. Use of acetaminophen within 24 hours of surgery.
• Concurrent painful physical condition or concurrent surgery that may require analgesic treatment (such as NSAID, opioid, SSRI, tricyclic antidepressant, gabapentin, pregabalin) in the postoperative period for pain that is not strictly related to the minimally invasive supracervical hysterectomy procedure and may confound the postoperative assessments (e.g., rheumatoid arthritis, chronic neuropathic pain.
• Chronic user of analgesic medications, including taking opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week.
• Current use of systemic glucocorticosteroids (e.g. Decadron) or use of glucocorticoids within one month of enrollment into this study.
• History of hepatitis (other than hepatitis A).
• History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• Failure of presurgical drug and alcohol screen.
• History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or propofol.
• Administration of an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
• \. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance. 13. Significant medical conditions or laboratory results that, in the opinion of the Investigator indicate an increased vulnerability to study drug and procedures, and expose subjects to an unreasonable risk as a result of participating in this clinical trial. 14. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postoperative course. 15. An incision length greater than 3 cm.

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (6)

• Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.

  PMID: 22067185 RESULT

• White PF. Multimodal analgesia: its role in preventing postoperative pain. Curr Opin Investig Drugs. 2008 Jan;9(1):76-82.

  PMID: 18183534 RESULT

• Smoot JD, Bergese SD, Onel E, Williams HT, Hedden W. The efficacy and safety of DepoFoam bupivacaine in patients undergoing bilateral, cosmetic, submuscular augmentation mammaplasty: a randomized, double-blind, active-control study. Aesthet Surg J. 2012 Jan;32(1):69-76. doi: 10.1177/1090820X11430831. Epub 2011 Dec 16.

  PMID: 22179931 RESULT

• Portillo J, Kamar N, Melibary S, Quevedo E, Bergese S. Safety of liposome extended-release bupivacaine for postoperative pain control. Front Pharmacol. 2014 Apr 30;5:90. doi: 10.3389/fphar.2014.00090. eCollection 2014.

  PMID: 24817851 RESULT

• Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):26-34. doi: 10.1097/AOG.0b013e3181c51ace.

  PMID: 20027030 RESULT

• Lukes AS, Roy KH, Presthus JB, Diamond MP, Berman JM, Konsker KA. Randomized comparative trial of cervical block protocols for pain management during hysteroscopic removal of polyps and myomas. Int J Womens Health. 2015 Oct 13;7:833-9. doi: 10.2147/IJWH.S50101. eCollection 2015.

  PMID: 26543383 RESULT

MeSH Terms

Conditions

Pain

Interventions

Saline Solution; Injections

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Pedram Bral, MD
• Organization: Maimonides Medical Center

pbral@maimonidesmed.org

7182836000

Study Officials

• Pedram Bral, M.D.

  Minimally Invasive Surgery -Fellowship Director

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Administration Director

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: December 7, 2018
• Study Start: October 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: January 9, 2024
• Results First Posted: January 9, 2024

Record last verified: 2024-01

Locations

US (1)