Laparoscopic HysterectomyNCT03350334
Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy
A study testing Duloxetine in people with Laparoscopic Hysterectomy and Postoperative Recovery, run by Acibadem University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Laparoscopic Hysterectomy, Postoperative Recovery, Postoperative Pain
- What is being tested?
- Duloxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Dec 2017to 15 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with benign gynecologic conditions (fibroids, pelvic pain, uterine prolapse) who are planned to undergo laparoscopic hysterectomy will be enrolled in the study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem Maslak Hospital
Sarıyer, Istanbul, 34457
About this study
Official title: Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy: A Prospective Randomized Placebo-controlled Study
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.
Read the 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.
- Being tested
- Duloxetine, placebo
- Keywords
- Duloxetine, laparoscopic hysterectomy, postoperative pain, postoperative recovery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
Peri-operative Duloxetine administration
placeboDrug
Placebo administration
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Active comparator | The patients who will be given 60 mg duloxetine 2 hours before surgery and 24 hours after surgery. Receives: Drug: Duloxetine |
| Placebo Control | Placebo comparator | The patients who will be given 60 mg placebo 2 hours before surgery and 24 hours after surgery. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after surgery
Secondary outcomes (2)
Narcotic analgesic consumption doses
Number of total narcotic analgesic consumption doses of the participants through the post-operative 24 hours.
Measured: 24 hours after surgery
Length of hospital stay
number of days participants stay in hospital
Measured: post-operative 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start4 Dec 2017
- Primary completion10 Mar 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic HysterectomyStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomised
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozguc Takmaz, Acibadem University
- Investigators
- Mete Gungor, MD,Prof, Study chair, Acibadem Maslak Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350334
- Sponsor's protocol ID
- Ob&Gyn Maslak
- Status last verified
- May 2018
- First submitted
- 13 Nov 2017
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing plan will be made at the end of the study
Publications
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.
PubMed 26421810YaDeau 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.
PubMed 27387351Ho 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.
PubMed 20573635Wong 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.
PubMed 25222675Myles 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.
PubMed 10740540
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy: A Prospective Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT03350334
- Acronym / sponsor ID
- Ob&Gyn Maslak
- Keywords
- Duloxetine, laparoscopic hysterectomy, postoperative pain, postoperative recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 10 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective randomised
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Active comparator | Drug: DuloxetineThe patients who will be given 60 mg duloxetine 2 hours before surgery and 24 hours after surgery. |
| Placebo Control | Placebo comparator | Drug: placeboThe patients who will be given 60 mg placebo 2 hours before surgery and 24 hours after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with benign gynecologic conditions (fibroids, pelvic pain, uterine prolapse) who are planned to undergo laparoscopic hysterectomy will be enrolled in the study
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineAlso: CymbaltaPeri-operative Duloxetine administration | Drug | Duloxetine |
| placeboPlacebo administration | Drug | Placebo Control |
Primary outcome
Quality of Recovery-40 questionnaire total score
Time frame: 24 hours after surgery
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.
2 secondary outcomes
Narcotic analgesic consumption doses
Time frame: 24 hours after surgery
Length of hospital stay
Time frame: post-operative 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Results publication: PubMed 26421810Castro-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 publication: PubMed 27387351YaDeau 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 publication: PubMed 20573635Ho 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 publication: PubMed 25222675Wong 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 publication: PubMed 10740540Myles 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.
- Individual participant dataSharing planned: Undecided. IPD sharing plan will be made at the end of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mete Gungor, MD,Prof study chair
Acibadem Maslak Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duloxetine in people with Laparoscopic Hysterectomy and Postoperative Recovery, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-40 questionnaire total score (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03350334, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.