AnesthesiaPhase 4NCT05103410
Impact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy
A Phase 4 study testing ARIPiprazole 30 MG in people with Anesthesia and Analgesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The analgesic effect of perioperative use of aripiprazole has not been fully investigated. So, this study aims to test the effects of aripiprazole versus placebo in reducing postoperative pain following laparoscopic hysterectomy and to explore the potential side effects. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Anesthesia, Analgesia, Hysterotomy
- What is being tested?
- ARIPiprazole 30 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2021to 10 Jan 2023
- Phase
- Phase 4
- 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physical status American Society of Anesthesiologist (ASA) I or II
- Electively scheduled for laparoscopic hysterectomy,
Who cannot join
- Patients who refuse to participate
- Body mass index (BMI) > 30
- ASA physical status > II
- Diabetes
- Major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological)
- Coagulation abnormalities
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- Pregnancy
- Known hypersensitivity to aripiprazole or contraindications to its use (a psychiatric illness, patients on antidepressants, dementia-related psychosis)
- History of drug addiction or alcohol abuse
- Mental retardation interfering with the evaluation of pain scores or PCA programs .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Preoperative Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy: A Randomized Controlled Clinical Trial
The analgesic effect of perioperative use of aripiprazole has not been fully investigated.
So, this study aims to test the effects of aripiprazole versus placebo in reducing postoperative pain following laparoscopic hysterectomy and to explore the potential side effects.
- Conditions
- Anesthesia, Analgesia, Hysterotomy
- Being tested
- ARIPiprazole 30 MG, Placebo
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARIPiprazole 30 MGDrug
Patients will receive Aripiprazole 30 mg tablet orally 3 h before surgery
PlaceboDrug
Patients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole | Active comparator | Patients will receive Aripiprazole 30 mg tablet orally 3 h before surgery Receives: Drug: ARIPiprazole 30 MG |
| Placebo | Placebo comparator | Patients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
First time to analgesic requirement
After extubation, an intravenous patient-controlled analgesia system, will be connected to the patient (Accufuser Plus® 100 ml, Woo Young Medical Co, Korea) will be prepared with 60 ml normal saline containing 60 mg morphine, it will be programmed to give and 0.5 ml bolus dose with lockout interval of 8 minutes. Time to first Bolus will be estimated considering extubation time is the zero time.
Measured: First 24 hours postoperatively
Secondary outcomes (2)
Total opioid consumption
Total morphine consumption per twenty four hours will be estimated
Measured: First 24 hours postoperatively
Visual analogue scale (VAS)
Pain scores will be evaluated by a blinded observer anesthesiologist at the time of arrival in the PACU, and 10, 20, 30 minutes, 1 h, 2h, 4, 6, 8, 10, 12, 16 and 24 hr thereafter using visual analogue scale (VAS) (0-10 cm: 0 = no pain, 10 = the worst pain possible). The patients will be instructed about usage of VAS preoperatively
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start10 Nov 2021
- Primary completion1 Jan 2023
- Study completion10 Jan 2023
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 AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Mohammed Alansary Amin Ahmed Helwa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103410
- Sponsor's protocol ID
- FMASU R 175/2021
- Status last verified
- Feb 2023
- First submitted
- 22 Oct 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alansary AM, Elbeialy MAK. Impact of Preoperative Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy: A Randomized Double-blind Placebo-controlled Trial. Clin J Pain. 2024 Jun 1;40(6):341-348. doi: 10.1097/AJP.0000000000001210.
PubMed 38450551
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05103410
- Acronym / sponsor ID
- FMASU R 175/2021
- Conditions
- Anesthesia, Analgesia, Hysterotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 2 Nov 2021 (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 analgesic effect of perioperative use of aripiprazole has not been fully investigated.
So, this study aims to test the effects of aripiprazole versus placebo in reducing postoperative pain following laparoscopic hysterectomy and to explore the potential side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | Active comparator | Drug: ARIPiprazole 30 MGPatients will receive Aripiprazole 30 mg tablet orally 3 h before surgery |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physical status American Society of Anesthesiologist (ASA) I or II
- Electively scheduled for laparoscopic hysterectomy,
Key exclusion criteria (10 listed)
- Patients who refuse to participate
- Body mass index (BMI) > 30
- ASA physical status > II
- Diabetes
- Major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological)
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 |
|---|---|---|
| ARIPiprazole 30 MGPatients will receive Aripiprazole 30 mg tablet orally 3 h before surgery | Drug | Aripiprazole |
| PlaceboPatients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery | Drug | Placebo |
Primary outcome
First time to analgesic requirement
Time frame: First 24 hours postoperatively
After extubation, an intravenous patient-controlled analgesia system, will be connected to the patient (Accufuser Plus® 100 ml, Woo Young Medical Co, Korea) will be prepared with 60 ml normal saline containing 60 mg morphine, it will be programmed to give and 0.5 ml bolus dose with lockout interval of 8 minutes. Time to first Bolus will be estimated considering extubation time is the zero time.
2 secondary outcomes
Total opioid consumption
Time frame: First 24 hours postoperatively
Visual analogue scale (VAS)
Time frame: First 24 hours 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 6 Feb 2023.
- Derived from this study: PubMed 38450551Alansary AM, Elbeialy MAK. Impact of Preoperative Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy: A Randomized Double-blind Placebo-controlled Trial. Clin J Pain. 2024 Jun 1;40(6):341-348. doi: 10.1097/AJP.0000000000001210.
- Individual participant dataSharing planned: Undecided
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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 Phase 4 study testing ARIPiprazole 30 MG in people with Anesthesia and Analgesia, run by Ain Shams 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 10 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 6 Feb 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
First time to analgesic requirement (time frame: First 24 hours postoperatively). 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 NCT05103410, 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 6 Feb 2023.