Ventral HerniaPhase 4NCT05388929
Methocarbamol in Ventral and Inguinal HR
A Phase 4 study testing Methocarbamol, Standard Opioid and Standard opioid plus methocarbamol in people with Ventral Hernia and Inguinal Hernia, run by Prisma Health-Upstate at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia, Inguinal Hernia
- What is being tested?
- Methocarbamol, Standard Opioid and Standard opioid plus methocarbamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2022to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- <18 y/o
- Pregnancy
- Chronic opioid users
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addition of Methocarbamol to Postoperative Multimodal Analgesic Regimen: A Prospective, Randomized Pilot Study
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.
Read more
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.
- Conditions
- Ventral Hernia, Inguinal Hernia
- Being tested
- Methocarbamol, Standard Opioid, Standard opioid plus methocarbamol
- Medical subject headings
- Hernia, Ventral, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethocarbamolDrug
Methocarbamol after surgery
Standard OpioidDrug
Standard opioid after surgery or at discharge
Standard opioid plus methocarbamolDrug
Standard opioid plus methocarbamol after surgery or at discharge
| Study group | Role | What they receive |
|---|---|---|
| primary ventral hernia repair or inguinal hernia repair | Experimental | Primary ventral hernias, including umbilical, epigastric, and Spigelian hernias.
Primary or recurrent inguinal hernias. Receives: Drug: Methocarbamol; Drug: Standard Opioid |
| open or robotic ventral hernia repair outpatient | Experimental | Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias. Receives: Drug: Standard Opioid; Drug: Standard opioid plus methocarbamol |
| open or robotic hernia repair inpatient | Experimental | Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias. Receives: Drug: Standard Opioid; Drug: Standard opioid plus methocarbamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients requiring a rescue opioid prescription
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.
Measured: 30 days post surgery
Average total morphine milligram equivalents (MME) consumption
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).
Measured: 30 days post surgery
Secondary outcomes (2)
European Registry of Abdominal Wall Hernias (EuraHS) Quality of Life tool scores
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).
Measured: 30 days post surgery
Visual Analog Scale pain scores
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).
Measured: 7 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start23 Jun 2022
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy A Warren, MD, Principal investigator, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388929
- Sponsor's protocol ID
- 1913843
- Status last verified
- Jul 2026
- First submitted
- 19 May 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Methocarbamol to Postoperative Multimodal Analgesic Regimen: A Prospective, Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT05388929
- Acronym / sponsor ID
- 1913843
- Conditions
- Ventral Hernia, Inguinal Hernia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| primary ventral hernia repair or inguinal hernia repair | Experimental | Drug: Methocarbamol, Drug: Standard OpioidPrimary ventral hernias, including umbilical, epigastric, and Spigelian hernias. Primary or recurrent inguinal hernias. |
| open or robotic ventral hernia repair outpatient | Experimental | Drug: Standard Opioid, Drug: Standard opioid plus methocarbamolOpen repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias. |
| open or robotic hernia repair inpatient | Experimental | Drug: Standard Opioid, Drug: Standard opioid plus methocarbamolOpen repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >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)
Key exclusion criteria (3 listed)
- <18 y/o
- Pregnancy
- Chronic opioid users
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethocarbamolMethocarbamol after surgery | Drug | primary ventral hernia repair or inguinal hernia repair |
| Standard OpioidStandard opioid after surgery or at discharge | Drug | open or robotic hernia repair inpatient, open or robotic ventral hernia repair outpatient, primary ventral hernia repair or inguinal hernia repair |
| Standard opioid plus methocarbamolStandard opioid plus methocarbamol after surgery or at discharge | Drug | open or robotic hernia repair inpatient, open or robotic ventral hernia repair outpatient |
Primary outcome
Proportion of patients requiring a rescue opioid prescription
Time frame: 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
Time frame: 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).
2 secondary outcomes
European Registry of Abdominal Wall Hernias (EuraHS) Quality of Life tool scores
Time frame: 30 days post surgery
Visual Analog Scale pain scores
Time frame: 7 days post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy A Warren, MD principal investigator
Prisma Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methocarbamol, Standard Opioid and Standard opioid plus methocarbamol in people with Ventral Hernia and Inguinal Hernia, run by Prisma Health-Upstate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients requiring a rescue opioid prescription (time frame: 30 days post surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.