Decreasing Narcotics in Advanced Pelvic Surgery
Phase 4
Completed
- Conditions
- ConstipationNarcotic UsePainNausea
- Interventions
- Registration Number
- NCT02110719
- Lead Sponsor
- Hartford Hospital
- Brief Summary
In recent years, there has been an emphasis on the creation of "enhanced-recovery", "fast-track" or "multi-modal" pathways to improve perioperative care (1-4). The goal of these programs is to reduce the length of hospital stay, decrease narcotic usage while improving pain control, accelerate post-operative recovery, and expedite return to baseline functional status. Pathways often are developed by a team of surgeons, nurses, pain specialists, anesthesiologists and other support staff. Postoperative components often involve multi-modal analgesia, early return to activity and early return to a regular diet. The goal of this study is to evaluate the efficacy of a multi-modal pain regimen in advanced pelvic surgery with a primary goal of decreasing narcotic usage.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 138
Inclusion Criteria
- women >/= 18 years old
- undergoing pelvic organ prolapse or incontinence surgery with the Urogynecology department
Exclusion Criteria
- males
- <18 years old
- women unwilling or unable to consent
- same-day-discharge surgery
- history of chronic pain for which they use medications
- current or active history of narcotic abuse
- sleep apnea
- liver or kidney dysfunction
- sulfa allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard oral acetaminophen Patients will be given the following: * no preoperative medications * intraoperative medications per anesthesia * postoperatively, patients will receive ibuprofen, tylenol and narcotics as needed Standard oral ibuprofen Patients will be given the following: * no preoperative medications * intraoperative medications per anesthesia * postoperatively, patients will receive ibuprofen, tylenol and narcotics as needed Standard percocet Patients will be given the following: * no preoperative medications * intraoperative medications per anesthesia * postoperatively, patients will receive ibuprofen, tylenol and narcotics as needed Standard vicodin Patients will be given the following: * no preoperative medications * intraoperative medications per anesthesia * postoperatively, patients will receive ibuprofen, tylenol and narcotics as needed Multimodal Celebrex Patients in the multimodal arm will receive the following: * preoperative celebrex and gabapentin * intraoperative IV acetaminophen, dexamethasone, zofran * postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics * patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics Multimodal IV acetaminophen Patients in the multimodal arm will receive the following: * preoperative celebrex and gabapentin * intraoperative IV acetaminophen, dexamethasone, zofran * postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics * patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics Multimodal oral acetaminophen Patients in the multimodal arm will receive the following: * preoperative celebrex and gabapentin * intraoperative IV acetaminophen, dexamethasone, zofran * postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics * patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics Multimodal dilaudid Patients in the multimodal arm will receive the following: * preoperative celebrex and gabapentin * intraoperative IV acetaminophen, dexamethasone, zofran * postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics * patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics Multimodal zofran Patients in the multimodal arm will receive the following: * preoperative celebrex and gabapentin * intraoperative IV acetaminophen, dexamethasone, zofran * postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics * patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics Multimodal oral ibuprofen Patients in the multimodal arm will receive the following: * preoperative celebrex and gabapentin * intraoperative IV acetaminophen, dexamethasone, zofran * postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics * patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics Standard dilaudid Patients will be given the following: * no preoperative medications * intraoperative medications per anesthesia * postoperatively, patients will receive ibuprofen, tylenol and narcotics as needed Multimodal Gabapentin Patients in the multimodal arm will receive the following: * preoperative celebrex and gabapentin * intraoperative IV acetaminophen, dexamethasone, zofran * postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics * patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics Multimodal Oxycodone Patients in the multimodal arm will receive the following: * preoperative celebrex and gabapentin * intraoperative IV acetaminophen, dexamethasone, zofran * postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics * patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics Multimodal Dexamethasone Patients in the multimodal arm will receive the following: * preoperative celebrex and gabapentin * intraoperative IV acetaminophen, dexamethasone, zofran * postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics * patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics
- Primary Outcome Measures
Name Time Method Narcotic use intraoperative, immediate postoperative and 1 week postoperative Narcotic use will be evaluated at all stages of the preoperative care: operating room, hospital floor and at the 1 week postoperative time point
- Secondary Outcome Measures
Name Time Method Constipation one week postoperatively constipation at the time of the first bowel movement will be evaluated using the validated Bristol Stool Scale
Pain postoperative day #1 and postoperative week #1 pain will be evaluated at the above listed time points using the validated brief pain inventory
Nausea intraoperatively, postoperatively Nausea will be evaluated based on the use of narcotics in the hospital
Trial Locations
- Locations (1)
Hartford Hosptial
🇺🇸Hartford, Connecticut, United States