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Gas Pressure Levels for Laparoscopic Surgery
N/A
Recruiting
Led By Matthew Siedhoff, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Undergoing laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.
Must not have
Baseline opioid use
Allergy or intolerance to bupivacaine (or amide class of anesthetics), oxycodone, acetaminophen, or ibuprofen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative
Awards & highlights
No Placebo-Only Group
Summary
"This trial will study how different levels of gas pressure during laparoscopic surgery affect pain after surgery and how well the surgeon can see during the operation."
Who is the study for?
This trial is for adults over 18 who are scheduled for laparoscopic surgery with a gynecologic surgeon at Cedars-Sinai Medical Center. Participants must sign a consent form and agree to follow the study's procedures throughout its duration.
What is being tested?
The study is testing the effects of different insufflation pressures (how much gas is used to inflate the abdomen) on post-surgery pain and how well surgeons can see inside during laparoscopic surgery, using drugs like Bupivacaine and Oxycodone.
What are the potential side effects?
Possible side effects may include discomfort or pain from carbon dioxide used in pneumoperitoneum, reactions to anesthetics like Bupivacaine, or typical opioid-related side effects from Oxycodone such as nausea, drowsiness, or constipation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am scheduled for a laparoscopic surgery at Cedars-Sinai with a specialized surgeon.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently using opioids for pain.
Select...
I am allergic to bupivacaine, oxycodone, acetaminophen, or ibuprofen.
Select...
I need surgery urgently and it wasn't planned.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day of surgery (postoperative day 0)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of surgery (postoperative day 0)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10)
Secondary study objectives
First reported pain score in PACU (numerical rating scale, 0-10)
Inpatient morphine milligram equivalents
Last reported pain score in PACU prior to discharge (numerical rating scale, 0-10)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: 12mmHg (Robotic-Assisted Laparoscopic Arm)Experimental Treatment3 Interventions
Lower Pressure, Robotic-Assisted Laparoscopic Arm
Group II: 12mmHg (Conventional Laparoscopic Arm)Experimental Treatment3 Interventions
Lower Pressure, Conventional Laparoscopic Arm
Group III: 10mmHg (Robotic-Assisted Laparoscopic Arm)Experimental Treatment3 Interventions
Lowest Pressure, Robotic-Assisted Laparoscopic Arm
Group IV: 10mmHg (Conventional Laparoscopic Arm)Experimental Treatment3 Interventions
Lowest Pressure, Conventional Laparoscopic Arm
Group V: 15mmHg (Conventional Laparoscopic Arm)Active Control3 Interventions
Standard Pressure, Conventional Laparoscopic Arm
Group VI: 15mmHg (Robotic-Assisted Laparoscopic Arm)Active Control3 Interventions
Standard Pressure, Robotic-Assisted Laparoscopic Arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
2013
Completed Phase 4
~1530
Oxycodone
2014
Completed Phase 4
~2210
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
513 Previous Clinical Trials
163,095 Total Patients Enrolled
Matthew Siedhoff, MDPrincipal InvestigatorCedars-Sinai Medical Center
1 Previous Clinical Trials
50 Total Patients Enrolled