Clinical trial

Addition of Methocarbamol to Postoperative Multimodal Analgesic Regimen: A Prospective, Randomized Pilot Study

Name
1913843
Description
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.
Trial arms
Trial start
2022-06-23
Estimated PCD
2024-05-01
Trial end
2025-05-01
Status
Recruiting
Phase
Early phase I
Treatment
Methocarbamol
Methocarbamol after surgery
Arms:
primary ventral hernia repair or inguinal hernia repair
Standard Opioid
Standard opioid after surgery or at discharge
Arms:
open or robotic hernia repair inpatient, open or robotic ventral hernia repair outpatient, primary ventral hernia repair or inguinal hernia repair
Standard opioid plus methocarbamol
Standard opioid plus methocarbamol after surgery or at discharge
Arms:
open or robotic hernia repair inpatient, open or robotic ventral hernia repair outpatient
Size
200
Primary endpoint
Proportion of patients requiring a rescue opioid prescription
30 days post surgery
Average total morphine milligram equivalents (MME) consumption
30 days post surgery
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2024-01-18

1 organization

3 products

2 indications

Indication
Hernia
Indication
Inguinal Hernia