Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy

Postoperative Pain Clinical Trial

Official title:

Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy: A Prospective Randomized Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350334
• Other study ID #: Ob&Gyn Maslak
• Status: Completed
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: March 15, 2018

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 15, 2018
• Est. primary completion date: March 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Hysterectomy
• Pain, Postoperative
• Postoperative Pain
• Postoperative Recovery

Intervention

Drug:
• Duloxetine
Peri-operative Duloxetine administration
• placebo
Placebo administration

Locations

Country	Name	City	State
Turkey	Acibadem Maslak Hospital	Sariyer	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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 — View 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. — View 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. — View 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.000 — View 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 Ran — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours after surgery
Secondary	Narcotic analgesic consumption doses	Number of total narcotic analgesic consumption doses of the participants through the post-operative 24 hours.	24 hours after surgery
Secondary	Length of hospital stay	number of days participants stay in hospital	post-operative 1 week