Methocarbamol in Ventral and Inguinal HR

Prisma Health-Upstate

Status and phase: Enrolling; Phase 4

Conditions: Ventral Hernia; Inguinal Hernia

Treatments: Drug: Standard Opioid; Drug: Standard opioid plus methocarbamol; Drug: Methocarbamol

Study type: Interventional

Funder types: Other

Identifiers

NCT05388929

1913843

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

primary ventral hernia repair or inguinal hernia repair

Experimental group

Description:

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

Treatment:

Drug: Methocarbamol

Drug: Standard Opioid

open or robotic ventral hernia repair outpatient

Experimental group

Description:

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

Treatment:

Drug: Standard opioid plus methocarbamol

Drug: Standard Opioid

open or robotic hernia repair inpatient

Experimental group

Description:

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

Treatment:

Drug: Standard opioid plus methocarbamol

Drug: Standard Opioid