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NCT01250002 · ClinicalTrials.gov registry record · NA
Lidocaine and Outpatient Gynecologic Laparoscopy
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
NCT01250002: Completed NA study, sponsored by Northwestern University.
NCT01250002 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 70 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01250002, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
Study Summary
Although ambulatory gynecological laparoscopy is considered to be a minimally invasive surgical procedure, only 60% of patients undergoing this procedure are satisfied with postoperative pain control. Postoperative pain can lead to physiological, immunological and psychological derangements in patients.It also has been shown to be the most common cause of hospital admission after outpatient surgery. Opioids constitute the most commonly used pain management strategy after surgery, however they have many undesirable side effects including nausea, vomiting and respiratory depression. Different strategies have been developed to decrease the amount of opioid required after surgery. Opioid sparing drugs as well as regional anesthesia have been shown to be effective. Systemic administration of lidocaine has been shown to decrease opioid consumption, improve recovery of bowel function and promote a better recovery after inpatient procedures. Lidocaine has been shown to have analgesic, antihyperalgesic and anti-inflammatory properties. It also has an excellent safety profile when give by a low-dose infusion. The improvement of surgical technique and anesthesia care has made major adverse outcomes infrequent, especially in the ambulatory setting. Assessing patient's quality of recovery has become an important outcome in several studies. The patient's capacity to return to his normal activities is one of the most important sign of a successful outpatient procedure and it has significant economic implications. Quality of recovery -40(QoR-40) is a validated 40 item instrument to assess the quality of post-operative recovery. Myels et al. have concluded that the QoR-40 would be a useful outcome measure to assess the impact on changes in health care delivery, but anesthesia studies underutilize this instrument. The research question for the study is; does the use of systemic perioperative lidocaine improve quality of recovery after outpatient laparoscopy?
Primary Outcome
Quality of recovery 40 score on the day after surgery. Scale ranges from a low of 40 (poor recovery) to a high of 200 (good recovery).
Interventions
- DRUG Placebo
- DRUG Lidocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-10 |
| Phase | NA |
What the finished NCT01250002 record still lists
NCT01250002 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01250002 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01250002 about?
NCT01250002 is a clinical study titled "Lidocaine and Outpatient Gynecologic Laparoscopy". Although ambulatory gynecological laparoscopy is considered to be a minimally invasive surgical procedure, only 60% of patients undergoing this procedure are satisfied with postoperative pain control. Postoperative pain can lead to physiological, immunological and psychological derangements in patie...
What is the current status of trial NCT01250002?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2010-11. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01250002?
The interventions under investigation include: Placebo (DRUG), Lidocaine (DRUG).
Who is sponsoring clinical trial NCT01250002?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01250002's enrollment target sits among peer trials
70 1103rd of 2000 higher than 868 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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