Trial Outcomes & Findings for Improving Pain Control in Paraesophageal Hernia Repair: Intravenous Lidocaine Versus Placebo (NCT NCT04096170)
NCT ID: NCT04096170
Last Updated: 2026-06-23
Results Overview
Postoperative consumption of morphine equivalents
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
Post-operation up to 48 hours
Results posted on
2026-06-23
Participant Flow
Participant milestones
| Measure |
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.
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
Patients will receive D5W solution at the same volume and rate as the IV lidocaine.
Placebo: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
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
Patients will receive D5W solution at the same volume and rate as the IV lidocaine.
Placebo: 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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Improving Pain Control in Paraesophageal Hernia Repair: Intravenous Lidocaine Versus Placebo
Baseline characteristics by cohort
| Measure |
IV Lidocaine
n=8 Participants
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.
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
n=7 Participants
Patients will receive D5W solution at the same volume and rate as the IV lidocaine.
Placebo: 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.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 6.7 • n=20 Participants
|
72.1 years
STANDARD_DEVIATION 5.6 • n=20 Participants
|
70.8 years
STANDARD_DEVIATION 6.2 • n=40 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Post-operation up to 48 hoursPostoperative consumption of morphine equivalents
Outcome measures
| Measure |
IV Lidocaine
n=8 Participants
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.
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
n=7 Participants
Patients will receive D5W solution at the same volume and rate as the IV lidocaine.
Placebo: 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.
|
|---|---|---|
|
Postoperative Morphine Equivalents
Hour 24
|
20.4 morphine milligram equivalents
Standard Deviation 8.0
|
9.1 morphine milligram equivalents
Standard Deviation 5.4
|
|
Postoperative Morphine Equivalents
Hour 48
|
22.5 morphine milligram equivalents
Standard Deviation 15.0
|
8.2 morphine milligram equivalents
Standard Deviation 14.1
|
PRIMARY outcome
Timeframe: post-op to 6 monthsPopulation: Discrepancies in participants at postoperative timeframes were due to some participants being discharged sooner than others. Discrepancies in participants at follow-up timeframes is due to participants missing follow-up appointments.
Visual Analogue Scale pain score 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).
Outcome measures
| Measure |
IV Lidocaine
n=8 Participants
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.
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
n=7 Participants
Patients will receive D5W solution at the same volume and rate as the IV lidocaine.
Placebo: 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.
|
|---|---|---|
|
Visual Analogue Scale Pain Score
Incision Pain Week 6
|
0.8 score on a scale
Standard Deviation 1.4
|
0 score on a scale
Standard Deviation 0
|
|
Visual Analogue Scale Pain Score
Incision Pain Month 6
|
0.3 score on a scale
Standard Deviation 0.7
|
0 score on a scale
Standard Deviation 0
|
|
Visual Analogue Scale Pain Score
Shoulder Pain Hour 6 Postoperative
|
5.0 score on a scale
Standard Deviation 3.7
|
3.1 score on a scale
Standard Deviation 3.2
|
|
Visual Analogue Scale Pain Score
Incision Pain Hour 6 Postoperative
|
3.9 score on a scale
Standard Deviation 3.0
|
3.3 score on a scale
Standard Deviation 3.3
|
|
Visual Analogue Scale Pain Score
Incision Pain Postoperative Day 1
|
5.3 score on a scale
Standard Deviation 3.5
|
5.9 score on a scale
Standard Deviation 4.0
|
|
Visual Analogue Scale Pain Score
Incision Pain Postoperative Day 2
|
5.6 score on a scale
Standard Deviation 2.6
|
4.2 score on a scale
Standard Deviation 3.3
|
|
Visual Analogue Scale Pain Score
Incision Pain Postoperative Day 3
|
6.3 score on a scale
Standard Deviation 2.3
|
5.0 score on a scale
Standard Deviation 1.4
|
|
Visual Analogue Scale Pain Score
Incision Pain Postoperative Day 4
|
3.0 score on a scale
Standard Deviation 2.8
|
—
|
|
Visual Analogue Scale Pain Score
Incision Pain Postoperative Day 5
|
1.5 score on a scale
Standard Deviation 2.1
|
—
|
|
Visual Analogue Scale Pain Score
Incision Pain Week 2
|
1.6 score on a scale
Standard Deviation 2.1
|
1.6 score on a scale
Standard Deviation 3.7
|
|
Visual Analogue Scale Pain Score
Shoulder Pain Postoperative Day 1
|
4.8 score on a scale
Standard Deviation 4.0
|
1.9 score on a scale
Standard Deviation 2.0
|
|
Visual Analogue Scale Pain Score
Shoulder Pain Postoperative Day 2
|
4.4 score on a scale
Standard Deviation 3.7
|
1.3 score on a scale
Standard Deviation 1.5
|
|
Visual Analogue Scale Pain Score
Shoulder Pain Postoperative Day 3
|
3.3 score on a scale
Standard Deviation 3.2
|
1.5 score on a scale
Standard Deviation 2.1
|
|
Visual Analogue Scale Pain Score
Shoulder Pain Postoperative Day 4
|
1.0 score on a scale
Standard Deviation 1.4
|
—
|
|
Visual Analogue Scale Pain Score
Shoulder Pain Postoperative Day 5
|
0 score on a scale
Standard Deviation 0
|
—
|
|
Visual Analogue Scale Pain Score
Postoperative Week 2
|
0.6 score on a scale
Standard Deviation 1.2
|
0 score on a scale
Standard Deviation 0
|
|
Visual Analogue Scale Pain Score
Postoperative Week 6
|
0.7 score on a scale
Standard Deviation 1.3
|
0 score on a scale
Standard Deviation 0
|
|
Visual Analogue Scale Pain Score
Postoperative Month 6
|
0.3 score on a scale
Standard Deviation 0.7
|
0 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: up to 1 weekLength of postoperative stay
Outcome measures
| Measure |
IV Lidocaine
n=8 Participants
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.
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
n=7 Participants
Patients will receive D5W solution at the same volume and rate as the IV lidocaine.
Placebo: 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.
|
|---|---|---|
|
Length of Stay
|
3.6 days
Standard Deviation 1.9
|
3.1 days
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: up to week 1We will track when each patient passes first bowel movement
Outcome measures
| Measure |
IV Lidocaine
n=8 Participants
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.
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
n=7 Participants
Patients will receive D5W solution at the same volume and rate as the IV lidocaine.
Placebo: 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.
|
|---|---|---|
|
Return of Bowel Function
|
2.5 days
Standard Deviation 1.0
|
1.8 days
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: up to day 2Number of hours until patient tolerates a normal diet
Outcome measures
| Measure |
IV Lidocaine
n=8 Participants
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.
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
n=7 Participants
Patients will receive D5W solution at the same volume and rate as the IV lidocaine.
Placebo: 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.
|
|---|---|---|
|
Hours to Toleration of Diet
|
24.0 hours
Standard Deviation 6.3
|
22.3 hours
Standard Deviation 2.3
|
Adverse Events
IV Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place