Effect of Preoperative Duloxetine on Quality of Recovery After Outpatient Laparoscopic Surgery

Laparoscopy Clinical Trial

Official title:

Effect of Preoperative Duloxetine on Quality of Recovery After Outpatient Laparoscopic Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02351440
• Other study ID #: STU00096889
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: August 31, 2017

Study information

• Verified date: August 2018
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine the effect of preoperative duloxetine on postoperative quality of recovery after ambulatory surgery, specifically laparoscopic gynecological surgery.

Description:

It has been demonstrated that female patients have poor quality of surgical recovery compared to male patients.1 Increased sensitivity to pain and increased susceptibility to postoperative nausea and vomiting have been attributed as causal factors.2, 3 Currently, few strategies have been shown to improve quality of recovery in female patients undergoing laparoscopic hysterectomy.4 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.

In addition, pain after ambulatory surgery remains an unsolved problem in The United States and Europe.5,6 It is associated with delayed hospital discharge and it can result to an increased opioid consumption with adverse side effects. The concept of multimodal analgesic technique was introduced more than 15 years ago and several techniques have been studied over the years including NSAIDs, acetaminophen, membrane stabilizers, ketamine, and local and regional anesthetic techniques.7,8 Both serotonin and norepinephrine have involvement in modulation of pain mechanisms in the central nervous system. Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor that has been used for mitigation of pain in such conditions as chronic musculoskeletal pain, diabetic peripheral neuropathic pain, post-herpetic neuralgia, and fibromyalgia.9,10 Duloxetine was also found to reduce postoperative morphine requirements in patients undergoing knee replacement surgery.11 The MQOR 40 is a validated instrument that was specifically design to evaluate patient recovery after anesthesia and surgery.12 This instrument can be particularly valid to examine interventions which affect different spheres of patient recovery as is the case of duloxetine.

A suicidal behavior questionnaire (SBQ-R) will be used to screen for suicidal risk among potential subjects. If any subject exhibits suicidal ideation as a result of scoring high on the questionnaire, there surgeon and/or primary care provider will be notified by the principal investigator.

The objective of this study is to determine the effect of preoperative duloxetine on postoperative quality of recovery after ambulatory surgery.

Significance: Use of preoperative duloxetine may improve patient's quality of recovery, decrease postoperative pain, opioid consumption and opioid related side effects after ambulatory surgery.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• outpatient gynecological laparoscopy

• ASA PS 1 and 2

• fluent in English

Exclusion Criteria:

• history of allergy to duloxetine, history of chronic opioid use, pregnant patients, preoperative SSRI or SNRI use, prolonged QT interval on ECG

Related Conditions & MeSH terms

• Gynecologic Surgery
• Laparoscopy
• Quality of Recovery

Intervention

Drug:
• duloxetine
patients will be randomized to receive either duloxetine or placebo
• placebo
placebo

Locations

Country	Name	City	State
United States	Prentice Womens Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QOR-40 global score		24 hours
Secondary	intraoperative opioid consumption	measure intraoperative opioid consumption in morphine IV equivalents in mg	1 hour