PREPARE: A PRospective Evaluation of Pain After Inguinal Hernia REpair
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Inguinal Hernia
- Sponsor
- Intuitive Surgical
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Change in Pain Scores from Baseline to 14 Days
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted inguinal hernia repair.
Detailed Description
This is a prospective, multi-center, observational pilot study comparing outcomes of pain and quality of life after inguinal hernia repair between open, laparoscopic, and robotic-assisted surgical approaches. The study will focus on short-term outcomes through 3 months post-operation. During the post-operative period through 3 months, pain medication intake, pill count, subject-reported pain (on post-operative days 1-3 and 14 days post-surgery), and quality of life (at 14 days, 30 days, and 3 months post-surgery), incidence of intra- and post-operative complications, and time to return to normal activity will be collected.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is between 18 and 80 years of age.
- •Subject is a candidate for an elective primary inguinal hernia repair.
Exclusion Criteria
- •Subject receiving a bilateral open repair.
- •Subject who will have an emergent hernia repair.
- •Subject with a history of chronic pain and/or taking daily pain medications for \>6 weeks.
- •Subject with a history of substance abuse and/or current (within 30 days) narcotic use.
- •Subject with a history of methicillin-resistant Staphylococcus aureus (MRSA) infection.
- •Diabetic subjects requiring insulin.
- •Subject with recurrent hernias.
- •Subject who will require the use of Exparel during the surgical procedure.
- •Subject who will undergo a concomitant hernia repair or any other concomitant procedure.
- •Current marijuana use that the subject is unwilling to discontinue within the 14 days prior to surgery.
Outcomes
Primary Outcomes
Change in Pain Scores from Baseline to 14 Days
Time Frame: 14 days post-surgery
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Change in Pain Scores from Baseline to 1 Day
Time Frame: 1 day post-surgery
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Change in Pain Scores from Baseline to 2 Days
Time Frame: 2 days post-surgery
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Change in Pain Scores from Baseline to 3 Days
Time Frame: 3 days post-surgery
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Change in Narcotic Usage from 1 Day Post-Surgery to 3 Months Post-Surgery
Time Frame: 3 months post-surgery
Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits
Change in Narcotic Usage from 1 Day Post-Surgery to 30 Days Post-Surgery
Time Frame: 30 days post-surgery
Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits
Change in Narcotic Usage from 1 Day Post-Surgery to 14 Days Post-Surgery
Time Frame: 14 days post-surgery
Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits
Change in Narcotic Usage from 1 Day Post-Surgery to 7 Days Post-Surgery
Time Frame: 7 days post-surgery
Narcotic usage after the inguinal hernia repair procedure as determined by patient Pain Diary completed at home
Secondary Outcomes
- Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 7 Days Post-Surgery(7 days post-surgery)
- Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 3 Months Post-Surgery(3 months post-surgery)
- Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 30 Days Post-Surgery(30 Days post-surgery)
- Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 14 Days Post-Surgery(14 Days post-surgery)
- Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 3 Months Post-Surgery(3 months post-surgery)
- Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 30 Days Post-Surgery(30 Days post-surgery)
- Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 14 Days Post-Surgery(14 Days post-surgery)
- Operative Time(Intra-operative)
- Length of Hospital Stay (LOS)(Admission to the hospital to discharge from the hospital (check out time), up to an approximate of one week)
- Conversion to Open(Intra-operative)
- Number of Complications(Intra-operative through the 3 month follow-up period)