Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy

NCT03350334 | Completed

• 1 other identifier: Ob&Gyn Maslak
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Hysterectomy; Postoperative Recovery; Postoperative Pain

Keywords

Duloxetine; laparoscopic hysterectomy; postoperative pain; postoperative recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Narcotic analgesic consumption doses

  24 hours after surgery

• Length of hospital stay

  post-operative 1 week

Study Arms (2)

Duloxetine

ACTIVE COMPARATOR

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

Drug: Duloxetine

Placebo Control

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Duloxetine DRUG

Peri-operative Duloxetine administration

Also known as: Cymbalta

Duloxetine

placebo DRUG

Placebo administration

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem Maslak Hospital

Sarıyer, Istanbul, 34457, Turkey (Türkiye)

Location

Related 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, Placebo-Controlled Study. Anesth Analg. 2016 Jan;122(1):98-104. doi: 10.1213/ANE.0000000000000971.

  PMID: 26421810 RESULT

• 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.

  PMID: 27387351 RESULT

• 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.

  PMID: 20573635 RESULT

• 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.

  PMID: 25222675 RESULT

• 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.

  PMID: 10740540 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mete Gungor, MD,Prof

  Acibadem Maslak Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants do not know whether they take placebo or Duloxetine
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.,Assist. Prof, Department of Obstetrics and Gynecology

Model Details: Prospective randomised

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 22, 2017
• Study Start: December 4, 2017
• Primary Completion: March 10, 2018
• Study Completion: March 15, 2018
• Last Updated: May 16, 2018

Record last verified: 2018-05

Locations

TU (1)