Acute PainNCT03468348
Duloxetine for Acute Post-mastectomy Pain
A study testing Duloxetine in people with Acute Pain, run by Assiut University at 1 site in Egypt.
Trial summary
The objective of this study is to evaluate the analgesic effect of oral dulexitine tablet (administered 2 h before surgery) as well as the ideal dose for acute postmastectomy pain. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Acute Pain
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 10 Feb 2020
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult females scheduled for unilateral MRM with axillary evacuation for breast cancer,
- American Society of Anesthesiologists physical status (ASA) class I and II
Who cannot join
- Patients with a known allergy to Duloxetine or morphine,
- A history of drug or alcohol abuse,
- Patients with impaired kidney or liver functions,
- Patients with chronic pain or regularly receiving analgesics,
- Any psychiatric illness that would interfere with the perception and the assessment of pain.
- Any reason that resulted in the protocol violation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duloxetine for Acute Post-mastectomy Pain: Placebo Controlled Dose Ranging Study
The objective of this study is to evaluate the analgesic effect of oral dulexitine tablet (administered 2 h before surgery) as well as the ideal dose for acute postmastectomy pain.
Read the detailed description
patients undergoing mastectomy with axillary evacuation will be divided to four groups, Placebo group: received placebo capsule Duloxetine 30: received duloxetine 30 mg capsule Duloxetine 60: received duloxetine 60 mg capsule Duloxetine 90: received duloxetine 90 mg capsule the study medication is administered orall 2 h before surgery. Primary outcome variable: the first postoperative 24 h morphine consumption Secondary outcome: the VAS pain score measured every 4 h in the first 24 h postoperatively.
- Conditions
- Acute Pain
- Being tested
- Duloxetine
- Keywords
- duloxetine, mastectomy, postoperative pain
- Medical subject headings
- Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
patients scheduled for mastectomy and axillary evacuation for cancer breast will receive orally, 2 hours before the operation either, placebo capsule, duloxetine 30 mg,duloxetine 60 mg or duloxetine 90 mg capsule.
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | Not described Receives: Drug: Duloxetine |
| duloxetine 30 | Active comparator | Not described Receives: Drug: Duloxetine |
| duloxetine 60 | Active comparator | Not described Receives: Drug: Duloxetine |
| duloxetine 90 | Active comparator | Not described Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the first postoperative 24 h (patient controlled analgesia [PCA])morphine consumption
the cumulative patient controlled analgesia morphine consumption required by the patients to relieve their pain in the first postoperative 24 h
Measured: the first postoperative 24 hour
Secondary outcomes (4)
The intensity of pain measured by visual analogue pain scale (VAS)
The intensity of pain measured by visual analogue pain scale (VAS) in which 0 = no pain and 10 = the maximum imaginable pain
Measured: The outcome will be assessed at 0 hour, 2 hour, 4 hour,8 hour, 16 hour and 24 hour postoperatively.
The quality of postoperative recovery, assessed by "The QoR-40 questionnaire" (the quality of recovery-40 questionnaire)
It measures five components of patient recovery: physical comfort (12 questions), physical independence (5 questions), emotional state (9 questions), psychological support (7 questions), and pain (7 questions). The sum of each component generates an aggregate score that ranges from 40 (i.e., extremely poor quality of recovery) to 200 (i.e., excellent quality of recovery)
Measured: the questionnair will be assessed once, 24 hour postoperatively
The level of consciousness assessed by "the Modified Ramsay Sedation score"
awake levels were: I = anxious, agitated, or restless; II = cooperative, oriented, and tranquil; III = responds to command, and asleep levels were dependent on patient's response to a light glabellar tap or loud auditory stimulus; IV= brisk response; V = a sluggish response; and VI = no response)
Measured: the score will be measured at 8 hour, 16 hour and 24 hour postoperatively
The occurrence of vomiting
vomiting is forceful discharge of stomach contents
Measured: The outcome will be obtained once 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Apr 2018
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diab Fuad Hetta, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468348
- Sponsor's protocol ID
- SECI-IRB-IORG0006563-437
- Status last verified
- Jun 2020
- First submitted
- 11 Mar 2018
- Last updated
- 24 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hetta DF, Elgalaly NA, Hetta HF, Fattah Mohammad MA. Preoperative Duloxetine to improve acute pain and quality of recovery in patients undergoing modified radical mastectomy: A dose-ranging randomized controlled trial. J Clin Anesth. 2020 Dec;67:110007. doi: 10.1016/j.jclinane.2020.110007. Epub 2020 Aug 22.
PubMed 32847776
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duloxetine for Acute Post-mastectomy Pain: Placebo Controlled Dose Ranging Study
- ClinicalTrials.gov ID
- NCT03468348
- Acronym / sponsor ID
- SECI-IRB-IORG0006563-437
- Conditions
- Acute Pain
- Keywords
- duloxetine, mastectomy, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 16 Mar 2018 (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 objective of this study is to evaluate the analgesic effect of oral dulexitine tablet (administered 2 h before surgery) as well as the ideal dose for acute postmastectomy pain.
Detailed description
patients undergoing mastectomy with axillary evacuation will be divided to four groups, Placebo group: received placebo capsule Duloxetine 30: received duloxetine 30 mg capsule Duloxetine 60: received duloxetine 60 mg capsule Duloxetine 90: received duloxetine 90 mg capsule the study medication is administered orall 2 h before surgery. Primary outcome variable: the first postoperative 24 h morphine consumption Secondary outcome: the VAS pain score measured every 4 h in the first 24 h postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Drug: Duloxetine |
| duloxetine 30 | Active comparator | Drug: Duloxetine |
| duloxetine 60 | Active comparator | Drug: Duloxetine |
| duloxetine 90 | Active comparator | Drug: Duloxetine |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult females scheduled for unilateral MRM with axillary evacuation for breast cancer,
- American Society of Anesthesiologists physical status (ASA) class I and II
Key exclusion criteria (6 listed)
- Patients with a known allergy to Duloxetine or morphine,
- A history of drug or alcohol abuse,
- Patients with impaired kidney or liver functions,
- Patients with chronic pain or regularly receiving analgesics,
- Any psychiatric illness that would interfere with the perception and the assessment of pain.
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 |
|---|---|---|
| Duloxetinepatients scheduled for mastectomy and axillary evacuation for cancer breast will receive orally, 2 hours before the operation either, placebo capsule, duloxetine 30 mg,duloxetine 60 mg or duloxetine 90 mg capsule. | Drug | duloxetine 30, duloxetine 60, duloxetine 90, placebo group |
Primary outcome
the first postoperative 24 h (patient controlled analgesia [PCA])morphine consumption
Time frame: the first postoperative 24 hour
the cumulative patient controlled analgesia morphine consumption required by the patients to relieve their pain in the first postoperative 24 h
4 secondary outcomes
The intensity of pain measured by visual analogue pain scale (VAS)
Time frame: The outcome will be assessed at 0 hour, 2 hour, 4 hour,8 hour, 16 hour and 24 hour postoperatively.
The quality of postoperative recovery, assessed by "The QoR-40 questionnaire" (the quality of recovery-40 questionnaire)
Time frame: the questionnair will be assessed once, 24 hour postoperatively
The level of consciousness assessed by "the Modified Ramsay Sedation score"
Time frame: the score will be measured at 8 hour, 16 hour and 24 hour postoperatively
The occurrence of vomiting
Time frame: The outcome will be obtained once 24 hour postoperatively
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 24 Jun 2020.
- Derived from this study: PubMed 32847776Hetta DF, Elgalaly NA, Hetta HF, Fattah Mohammad MA. Preoperative Duloxetine to improve acute pain and quality of recovery in patients undergoing modified radical mastectomy: A dose-ranging randomized controlled trial. J Clin Anesth. 2020 Dec;67:110007. doi: 10.1016/j.jclinane.2020.110007. Epub 2020 Aug 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Pain, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 6 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 24 Jun 2020. 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 Egypt. 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?
the first postoperative 24 h (patient controlled analgesia [PCA])morphine consumption (time frame: the first postoperative 24 hour). 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 NCT03468348, which also lists 1 linked publication.
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 24 Jun 2020.