Clinical trial NCT02053558: (TAP) Block vs. Systemic Lidocaine: Effects on Recovery
Official title: Tranversus Abdominis Plane (TAP) Block vs. Systemic Lidocaine to Improve Quality of Recovery After Outpatient Laparoscopic Surgery: A Non-inferiority, Randomized, Double Blinded, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain
Surgery
Keywords: Anesthesiology
Pain
TAP block
Gynecology
Postoperative
Analgesia
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It has been demonstrated that female patients have poor quality of surgical recovery compared to male patients. Increased sensitivity to pain and increased susceptibility to postoperative nausea and vomiting have been attributed as causal factors. Currently, few strategies have been shown to improve quality of recovery in female patients undergoing laparoscopic hysterectomy. A better recovery in female patients undergoing outpatient laparoscopy is particularly desirable since those patients do not have access to potent intravenous medications and nursing support after hospital discharge.

Our group has previously demonstrated that both TAP block and systemic lidocaine improve quality of recovery after outpatient laparoscopic gynecological surgery. The TAP block, however, requires expertise, equipment (ultrasound), and additional time to perform as compared with a simple lidocaine infusion. It is currently unknown if a systemic lidocaine infusion provides non-inferior quality of recovery when compared to TAP block for outpatient laparoscopic gynecological surgery.

The main objective of the current investigation is to examine the effect of TAP block on quality of recovery compared to a systemic lidocaine infusion. We hypothesize that systemic lidocaine infusion would provide non-inferior quality of recovery when compared to TAP block for outpatient laparoscopic gynecological surgery.

Significance: This is the first study to compare systemic lidocaine to TAP block with regard to quality of recovery.

The research question; does systemic lidocaine provide similar quality of recovery as TAP block for outpatient laparoscopy? The hypothesis; systemic lidocaine provides non-inferior quality of recovery as TAP block for outpatient laparoscopy.

Research significance: It has been shown that females have poor surgical recovery compared to males; this project intends to demonstrate that systemic lidocaine provides similar recovery as TAP blocks but it does not require the expertise, equipment, and time needed to perform TAP blocks.


Eligibility criteria: Inclusion Criteria:

* Age: 18-65 years of age
* Surgery type: Outpatient Gynecological Laparoscopy
* ASA status: I and II
* Fluent in English

Exclusion Criteria:

* History of allergy to local anesthetics
* History of chronic opioid use
* Pregnant patients
* Drop Out: Conversion to open surgery, patient or surgeon request.

Primary outcomes:
measure: QoR-40 global score at 24 hours
timeFrame: 24 hours post operative
Secondary outcomes:
measure: Morphine consumption at 24 hours post operative
timeFrame: 24 hours post operative
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Meghan Rodes, MD
role: PRINCIPAL_INVESTIGATOR
References: