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Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy

Primary Purpose

Laparoscopic Hysterectomy, Postoperative Recovery, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Duloxetine
placebo
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Hysterectomy focused on measuring Duloxetine, laparoscopic hysterectomy, postoperative pain, postoperative recovery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with benign gynecologic conditions (fibroids, pelvic pain, uterine prolapse) who are planned to undergo laparoscopic hysterectomy will be enrolled in the study

Exclusion Criteria:

  • Patients with chronic non-gynecologic conditions (liver or pulmonary disease, diabetes), using psychiatric drugs (anti-depressants, neuroleptics, lithium) in the last 1 year, those with duloxetine allergy, and patients using opioids for gynecologic or non-gynecologic conditions will be excluded from the study.

Sites / Locations

  • Acibadem Maslak Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Duloxetine

Placebo Control

Arm Description

The patients who will be given 60 mg duloxetine 2 hours before surgery and 24 hours after surgery.

The patients who will be given 60 mg placebo 2 hours before surgery and 24 hours after surgery.

Outcomes

Primary Outcome Measures

Quality of Recovery-40 questionnaire total score
Total scores of the Quality of Recovery-40 scale will be obtained 24 hours after surgery. Quality of Recovery-40 scale is a validated post-operative recovery questionnaire that consists of 40 questions, and 5 sub-components for pain (7), physical comfort (12), physical independence (5), emotional state (9), and psychological support (7). Positive items are scored from 1 (worst) to 5 (best); scores are reversed for negative items. Each item is scored ranging from 1 to 5. Total questionnaire score is calculated by sum of all items, and also sub-components by the sum of corresponding items. The total score ranges from 40 to 200.

Secondary Outcome Measures

Narcotic analgesic consumption doses
Number of total narcotic analgesic consumption doses of the participants through the post-operative 24 hours.
Length of hospital stay
number of days participants stay in hospital

Full Information

First Posted
November 13, 2017
Last Updated
May 15, 2018
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT03350334
Brief Title
Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy
Official Title
Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy: A Prospective Randomized Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
March 10, 2018 (Actual)
Study Completion Date
March 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the investigators of the study is to evaluate the effect of peri-operative duloxetine on post-operative recovery in patients undergoing laparoscopic hysterectomy.
Detailed Description
Patients with benign gynecologic conditions (fibroids, pelvic pain, uterine prolapse) who are planned to undergo laparoscopic hysterectomy will be enrolled in the study. After randomization, the study participants will be given 60 mg duloxetine 2 hours before surgery and 24 hours after surgery, whereas the control participants will be given placebo tablets.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Hysterectomy, Postoperative Recovery, Postoperative Pain
Keywords
Duloxetine, laparoscopic hysterectomy, postoperative pain, postoperative recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomised
Masking
Participant
Masking Description
Participants do not know whether they take placebo or Duloxetine
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine
Arm Type
Active Comparator
Arm Description
The patients who will be given 60 mg duloxetine 2 hours before surgery and 24 hours after surgery.
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
The patients who will be given 60 mg placebo 2 hours before surgery and 24 hours after surgery.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
Peri-operative Duloxetine administration
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo administration
Primary Outcome Measure Information:
Title
Quality of Recovery-40 questionnaire total score
Description
Total scores of the Quality of Recovery-40 scale will be obtained 24 hours after surgery. Quality of Recovery-40 scale is a validated post-operative recovery questionnaire that consists of 40 questions, and 5 sub-components for pain (7), physical comfort (12), physical independence (5), emotional state (9), and psychological support (7). Positive items are scored from 1 (worst) to 5 (best); scores are reversed for negative items. Each item is scored ranging from 1 to 5. Total questionnaire score is calculated by sum of all items, and also sub-components by the sum of corresponding items. The total score ranges from 40 to 200.
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Narcotic analgesic consumption doses
Description
Number of total narcotic analgesic consumption doses of the participants through the post-operative 24 hours.
Time Frame
24 hours after surgery
Title
Length of hospital stay
Description
number of days participants stay in hospital
Time Frame
post-operative 1 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with benign gynecologic conditions (fibroids, pelvic pain, uterine prolapse) who are planned to undergo laparoscopic hysterectomy will be enrolled in the study Exclusion Criteria: Patients with chronic non-gynecologic conditions (liver or pulmonary disease, diabetes), using psychiatric drugs (anti-depressants, neuroleptics, lithium) in the last 1 year, those with duloxetine allergy, and patients using opioids for gynecologic or non-gynecologic conditions will be excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mete Gungor, MD,Prof
Organizational Affiliation
Acibadem Maslak Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Acibadem Maslak Hospital
City
Sariyer
State/Province
Istanbul
ZIP/Postal Code
34457
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD sharing plan will be made at the end of the study
Citations:
PubMed Identifier
26421810
Citation
Castro-Alves LJ, Oliveira de Medeiros AC, Neves SP, Carneiro de Albuquerque CL, Modolo NS, De Azevedo VL, De Oliveira GS Jr. Perioperative Duloxetine to Improve Postoperative Recovery After Abdominal Hysterectomy: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study. Anesth Analg. 2016 Jan;122(1):98-104. doi: 10.1213/ANE.0000000000000971.
Results Reference
result
PubMed Identifier
27387351
Citation
YaDeau JT, Brummett CM, Mayman DJ, Lin Y, Goytizolo EA, Padgett DE, Alexiades MM, Kahn RL, Jules-Elysee KM, Fields KG, Goon AK, Gadulov Y, Westrich G. Duloxetine and Subacute Pain after Knee Arthroplasty when Added to a Multimodal Analgesic Regimen: A Randomized, Placebo-controlled, Triple-blinded Trial. Anesthesiology. 2016 Sep;125(3):561-72. doi: 10.1097/ALN.0000000000001228.
Results Reference
result
PubMed Identifier
20573635
Citation
Ho KY, Tay W, Yeo MC, Liu H, Yeo SJ, Chia SL, Lo NN. Duloxetine reduces morphine requirements after knee replacement surgery. Br J Anaesth. 2010 Sep;105(3):371-6. doi: 10.1093/bja/aeq158. Epub 2010 Jun 23.
Results Reference
result
PubMed Identifier
25222675
Citation
Wong K, Phelan R, Kalso E, Galvin I, Goldstein D, Raja S, Gilron I. Antidepressant drugs for prevention of acute and chronic postsurgical pain: early evidence and recommended future directions. Anesthesiology. 2014 Sep;121(3):591-608. doi: 10.1097/ALN.0000000000000307.
Results Reference
result
PubMed Identifier
10740540
Citation
Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
Results Reference
result

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Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy

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