Using IV lidocaine to improve pain control after paraesophageal hernia repair

Improving Pain Control in Paraesophageal Hernia Repair: Intravenous Lidocaine Versus Placebo

This study is testing if giving IV lidocaine can help people manage pain better after surgery for a paraesophageal hernia compared to a placebo.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Wake Forest University Health Sciences (other)
• Locations: 1 site (Charlotte, North Carolina)
• Trial ID: NCT04096170 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of intravenous lidocaine on postoperative pain management in patients undergoing paraesophageal hernia repair. It is a randomized, two-arm trial comparing IV lidocaine to a placebo, with both groups receiving standard multimodal pain control. The study aims to assess outcomes such as narcotic use, return to bowel function, length of hospital stay, and overall quality of life. Participants will be followed for approximately six months to evaluate the effectiveness of lidocaine in reducing pain and improving recovery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are scheduled for elective laparoscopic paraesophageal hernia repair.

Not a fit: Patients with end-stage renal disease or allergies to lidocaine will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better pain management and quicker recovery for patients undergoing paraesophageal hernia repair.

How similar studies have performed: Other studies have shown promising results with the use of IV lidocaine for pain management, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* Patients aged 18+ years of age
* American Association of Anesthesiologists (ASA) scores of I-III
* Undergoing elective laparoscopic paraesophageal hernia repair including robotic assisted laparoscopic cases.
* All paraesophageal hernia patients seen in clinic who meet inclusion criteria will be given the option to enroll.
* Cases converted to open laparotomy or hand-assisted laparoscopy will be included for intention to treat analysis.
* Patients who have complications of Clavien-Dindo class 3 or greater will be included in calculations of complication rates. However, they will not be included in calculations of postoperative morphine equivalents, as repeat intervention will confound the normal course of postoperative pain control.

Exclusion Criteria:

* Patients with end stage renal disease
* Patients with allergies to lidocaine and other amide local anesthetics.
* Patients with contraindications to sodium channel blockers.
* Patients with psychomotor retardation
* Patients with body mass index \>40 mg/kg2.
* Patients receiving opioid pain medication in the previous week or taking daily medication for chronic pain
* Patients with a seizure disorder
* Patients with cardiac intraventricular conduction delays, congestive heart failure, first and second-degree heart conduction blocks.
* Patients undergoing planned concomitant procedures other than PEH repair
* Patients that are classified as ASA 4 or 5 during pre-operative anesthesia visit (if needed) will be excluded. Documentation from the pre-op visit will be reviewed by the research team prior to the surgery date.
* Exclusion from all or portions will be at the discretion of the attending surgeon and anesthesiologist.

Where this trial is running

Charlotte, North Carolina

• Atrium Health - Carolinas Medical Center — Charlotte, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Paul D Colavita, MD — Wake Forest University Health Sciences
• Study coordinator: Greg Scarola

Conditions: Hernia, Paraesophageal