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Active, not recruitingNCT05388929Updated Jul 10, 2026

Methocarbamol in Ventral and Inguinal HR

A Phase 4 interventional study of Methocarbamol and Standard Opioid in Ventral Hernia and Inguinal Hernia, sponsored by Prisma Health-Upstate. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Prisma Health-Upstate · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
164
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 94 studies in Hernia, Ventral with a site in United States — 14 open to participants now, 24 under way, none of them phase 3. Hernia, Ventral · United States.

Enrollment
20th of 70
164 · median 100
Started
2022
with 7 others
Phase 4
8 of 94
2 open now
Primary completion
2027-06
later than 15 of 23 live
Registered
65th of 94
by date
Lead sponsor
3 of 94
Prisma Health-Upstate

Among the 94 studies in Hernia, Ventral with a site in United States, this one is the 20th largest by enrollment of the 70 interventional ones that give a count, is one of 8 that started in 2022, is one of 8 in phase 4, reaches primary completion later than 15 of the 23 other live ones, and was the 65th registered.

Hernia, Ventral

230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.

Browse Hernia, Ventral studies →

Open to participants now

14 of the 94 studies in Hernia, Ventral with a site in United States are open now. Recruiting first, the newest first:

9 more — sign in →

All 14 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 26 Hernia, Ventral studies recruiting now, 19 (73%) set no upper age limit and 4 (15%) stop at 75 or younger; 1 takes children under 18; 6 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Ventral Hernia
  • Inguinal Hernia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • \<18 y/o
  • Pregnancy
  • Chronic opioid users
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
164 participants (actual)

Study arms

  • Experimental
    primary ventral hernia repair or inguinal hernia repair

    Primary ventral hernias, including umbilical, epigastric, and Spigelian hernias. Primary or recurrent inguinal hernias.

    Drug: Methocarbamol · Drug: Standard Opioid

  • Experimental
    open or robotic ventral hernia repair outpatient

    Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.

    Drug: Standard Opioid · Drug: Standard opioid plus methocarbamol

  • Experimental
    open or robotic hernia repair inpatient

    Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.

    Drug: Standard Opioid · Drug: Standard opioid plus methocarbamol

Interventions

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days post surgery

  2. 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).

    Time frame: 30 days post surgery

Secondary outcomes

  1. 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).

    Time frame: 30 days post surgery

  2. 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).

    Time frame: 7 days post surgery

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2022 (actual). Primary completion is estimated for Jun 2027, 60 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 19, 2022
First posted
May 24, 2022
StartActual
Jun 23, 2022
Primary completionEst.
Jun 2027
CompletionEst.
Dec 2027
Last update
Jul 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05388929
Lead sponsor
Prisma Health-Upstate
Responsible party
Sponsor
First posted
May 24, 2022
Start date
Jun 23, 2022
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 10, 2026

Study contacts

Jeremy A Warren, MD
principal investigator · Prisma Health

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Methocarbamol

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