Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT03196505
Eligibility Criteria:
Inclusion Criteria:
* All patients undergoing elective laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass surgeries.
* Fulfills NIH criteria for bariatric surgery
Exclusion Criteria:
* Patients deemed not a candidate for laparoscopic bariatric surgery
* Patients with previous bariatric or gastric surgeries.
* BMI \<35 and \> 60 kg/m2
* Preoperative inability to ambulate and confined to wheelchair.
* American Society of Anesthesiologist (ASA) score \>3
* Concurrent ventral hernia repair or intraoperative extensive lysis of adhesions
* Not able to understand informed consent, or unwilling to sign consent.
* Not able to understand and read English
* Currently pregnant or lactating.
* Age \<18 or \>65
* Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.
* Patients requiring opiate use within 30 days prior to time of surgery.
* Patients with reported use of narcotics greater than 2 weeks in preceding year before surgery.
* Patients with history of substance abuse, alcohol addiction
* Patients with diagnosis of chronic pain, history of fibromyalgia, chronic regional pain syndrome (dystrophic pain syndrome).
* Bupivacaine use within 96 hours before operation
* Prisoners
* Bariatric surgery operation \>3 hours.
* More than 5 laparoscopic incision sites used during surgery, conversion to open operation, placement of a feeding tube or drain.
* Patients with renal failure or hepatic failure.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03196505
Study Brief:
Protocol Section:
NCT03196505