Ventral Hernia, Inguinal Hernia
Conditions
Brief summary
The purpose of this study is to gather information on methocarbamol as a pain management treatment for ventral or inguinal hernia repair. Methocarbamol has been part of the pain management treatment for both inpatient and outpatient procedures at Prisma Health. This study will compare the outcomes of patients who receive methocarbamol, those who receive the standard opioid pain management treatment, and those who receive methocarbamol plus the standard opioid pain management treatment. Participants will be randomized into one of the study groups listed below. Primary ventral hernia repair or inguinal hernia repair: Group 1: standard opioid after surgery Group 2: methocarbamol after surgery Open or robotic ventral hernia repair outpatient: Group 1: standard opioid after surgery Group 2: standard opioid plus methocarbamol after surgery Open or robotic ventral hernia repair inpatient: Group 1: standard opioid at discharge Group 2: standard opioid plus methocarbamol at discharge A total of 200 participants will be included in the study. Participation will last for about 30 days after surgery.
Interventions
DRUGMethocarbamol
Methocarbamol after surgery
DRUGStandard Opioid
Standard opioid after surgery or at discharge
DRUGStandard opioid plus methocarbamol
Standard opioid plus methocarbamol after surgery or at discharge
Sponsors
Prisma Health-Upstate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 y/o * Patients undergoing open primary ventral hernia repair (group 1) * Patients undergoing inguinal hernia repair (open, laparoscopic, or robotic; group 2) * Patients undergoing open incisional hernia repair (group 3) * Robotic repair ventral or incisional hernias (group 4) * Given consent for randomization
Exclusion criteria
* \<18 y/o * Pregnancy * Chronic opioid users
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients requiring a rescue opioid prescription | 30 days post surgery | The proportion of patients requiring a rescue opioid prescription will be compared between the study and control groups using the Fisher's Exact Test (bivariate analysis). Multiple logistic regression analysis will then be used to test for a difference in this outcome, adjusting for any baseline differences between the 2 study groups. |
| Average total morphine milligram equivalents (MME) consumption | 30 days post surgery | Average total MME consumption will be compared between the study and control groups using either the Student's T-test or the Wilcoxon Rank Sum Test (depends on distribution of the data -- parametric vs. non-parametric). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| European Registry of Abdominal Wall Hernias (EuraHS) Quality of Life tool scores | 30 days post surgery | Scale of 0-10, where 0 = no pain and 10 = worst pain imaginable. Outcome will be compared between the study and control groups using either the Student's T-test or the Wilcoxon Rank Sum Test. Statistical tests used are dependent on the data distribution -- parametric vs. non-parametric). |
| Visual Analog Scale pain scores | 7 days post surgery | Scale of 0-10, where 0 = no pain and 10 = worst pain imaginable. Outcome will be compared between the study and control groups using either the Student's T-test or the Wilcoxon Rank Sum Test. Statistical tests used are dependent on the data distribution -- parametric vs. non-parametric). |
Countries
United States
Outcome results
None listed