Improving Pain Control in Paraesophageal Hernia Repair: Intravenous Lidocaine Versus Placebo (PEH)
|ClinicalTrials.gov Identifier: NCT04096170|
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : September 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hernia, Paraesophageal||Drug: IV lidocaine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improving Pain Control in Paraesophageal Hernia Repair: Intravenous Lidocaine Versus Placebo|
|Actual Study Start Date :||June 21, 2018|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2021|
Experimental: IV Lidocaine
100 mg Lidocaine bolus on induction, then an infusion of 1.5 mg/kg/hr to begin prior to incision, run throughout the operation and continues into PACU for 1 hour OR until one 2gm/250mL D5W bag has been infused, whichever occurs first. The Patient will be monitored by nursing staff with the aid of continuous cardiac monitoring in the PACU for at least 30 minutes after the discontinuation of the lidocaine drip.
Drug: IV lidocaine
Patients randomized to the IV lidocaine group will receive a 100 mg lidocaine bolus on induction then an infusion of 1.5 mg/kg/hr prior to incision. This infusion will continue throughout operation and into the PACU for 1 hour OR until the 2gm/250 mL D5W bag has been infused, whichever occurs first.
Placebo Comparator: Placebo
Patients will receive D5W solution at the same volume and rate as the IV lidocaine.
o Patients randomized to the placebo group will receive D5W solution (as this is the carrier for lidocaine) at the same volume and rate as the IV lidocaine.
- Post-Op Morphine Equivalents [ Time Frame: Post-operation up to 6 months ]Post-operative consumption of morphine equivalents
- VAS Pain Score [ Time Frame: post-op to 6 months ]VAS is the standard nursing method of documenting pain using pain scores. The nurses ask the patient to rate pain from 0 (no pain) to 10 (excruciating pain).
- Length of Stay [ Time Frame: up to 6 months ]Length of stay post op
- Return of bowel function [ Time Frame: up to 6 months ]We will track when each patient passes first bowel movement expressed as hours since operation
- Day to toleration of diet [ Time Frame: up to 6 months ]When the patient tolerates a normal diet
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096170