(TAP) Block vs. Systemic Lidocaine: Effects on Recovery

Pain Clinical Trial

— TAP  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02053558
• Other study ID #: STU00086849
• Status: Withdrawn
• Phase: N/A
• Start date: November 3, 2014
• Est. completion date: February 2017

Study information

• Verified date: December 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Surgery

Intervention

Drug:
• Systemic lidocaine
Systemic lidocaine group will receive a lidocaine 1.5 mg/kg bolus after induction of anesthesia followed by a 2mg/kg/hr infusion and sham bilateral TAP blocks with normal saline 15mL on each side.
• TAP BLOCK with ropivacaine
TAP block group will receive bilateral TAP blocks using ultrasound guidance with 0.5% ropivacaine 15mL on each side and a bolus and infusion of normal saline after induction of anesthesia.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QoR-40 global score at 24 hours	QoR-40 global score at 24 hours	24 hours post operative
Secondary	Morphine consumption at 24 hours post operative	Total amount of morphine used in the 24 hour period post operative.	24 hours post operative