EXPAREL for Minimally Invasive Supracervical Hysterectomies
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|ClinicalTrials.gov Identifier: NCT03769714|
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Saline Solution for Injection Drug: Exparel||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Placebo-controlled, Double-blinded, Randomized Pilot Study of Bupivacaine Liposome Injectable Suspension (EXPAREL) for Minimally Invasive Supracervical Hysterectomies Postsurgical Analgesia|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Active Comparator: Saline Solution for Injection
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
Injection of 20mL of 0.9%Normal Saline
Other Name: Standard
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).
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.
Other Name: liposomal bupivicaine
- Pain at 12 hours [ Time Frame: 12 hours after surgery ]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
- Pain at 24 hours [ Time Frame: 24 hours after surgey ]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 24 hours postoperatively
- Painat 48 hours [ Time Frame: 48 hours after surgery ]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
- Patients with additional pain medications [ Time Frame: 48 hours ]Number of patients who required additional pain medications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769714
|Contact: Mary Ann H Son, M.D.||firstname.lastname@example.org|
|Contact: Camilla Paiva, M.D.||954 496 1275||Cpaiva@maimonidesmed.org|
|United States, New York|
|Maimonides Medical Center||Recruiting|
|Brooklyn, New York, United States, 11219|
|Contact: Mary Ann Son, MD email@example.com|
|Contact: Pedram Bral, MD firstname.lastname@example.org|
|Principal Investigator:||Pedram Bral, M.D.||Minimally Invasive Surgery -Fellowship Director|