AnalgesiaNCT05334160
Pain and Abdominal Breathing Exercises
An observational study of Analgesia and Breathing, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative evaluation of patients who did and did not do preoperative abdominal breathing exercises. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 15 May 2022
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gallbladder surgerysurgery patients who will be operated under general anesthesia.
Who may be able to join
- Planned to gall bladder surgery
- An American Society of Anesthesiologists score of 1,2 or 3
Who cannot join
- Severe cardiovascular disease
- Respiratory disease
- Psychiatric disease
- Those who have chronic pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Postoperative Effects of Preoperative Abdominal Breathing Exercises in Laparoscopic Cholecystectomy Operations
Postoperative evaluation of patients who did and did not do preoperative abdominal breathing exercises.
Read the detailed description
The respiratory type and pattern of all patients will be recorded before gallbladder surgery.
In Group P, abdominal breathing training will be given to the patients in this group. They will perform abdominal breathing for at least 5 minutes 6 times a day until surgery.
In Group C,patients who are not given abdominal breathing.
In the intraoperative period, 10 mg / kg paracetamol and 0.05 mg / kg morphine will be used for postoperative analgesia. After surgery, all patients will be given 10 mg/kg paracetamol every 8 hours and will be fitted with a patient-controlled analgesia (PCA) device (Tramadol HCL). PCA device bolus dose will be set to 20 mg, lock time will be set to 10 minutes and the number of buttons per hour will be set as 3.for postoperative analgesia.After surgery, NRS scores of the patients will be evaluated (in the recovery room, 1,2,6,12 and 24 hours.
Preoperative anxiety, postoperative discharge time and analgesic consumption of all patients will be recorded.
- Medical subject headings
- Agnosia, Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Measured: During postoperative up to 24 hours
NRS
Measured: During postoperative up to 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start15 Nov 2021
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Tapar, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334160
- Sponsor's protocol ID
- 21-KAEK-230
- Status last verified
- Sep 2022
- First submitted
- 10 Apr 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Postoperative Effects of Preoperative Abdominal Breathing Exercises in Laparoscopic Cholecystectomy Operations
- ClinicalTrials.gov ID
- NCT05334160
- Acronym / sponsor ID
- 21-KAEK-230
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 19 Apr 2022 (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.
Postoperative evaluation of patients who did and did not do preoperative abdominal breathing exercises.
Detailed description
The respiratory type and pattern of all patients will be recorded before gallbladder surgery.
In Group P, abdominal breathing training will be given to the patients in this group. They will perform abdominal breathing for at least 5 minutes 6 times a day until surgery.
In Group C,patients who are not given abdominal breathing.
In the intraoperative period, 10 mg / kg paracetamol and 0.05 mg / kg morphine will be used for postoperative analgesia. After surgery, all patients will be given 10 mg/kg paracetamol every 8 hours and will be fitted with a patient-controlled analgesia (PCA) device (Tramadol HCL). PCA device bolus dose will be set to 20 mg, lock time will be set to 10 minutes and the number of buttons per hour will be set as 3.for postoperative analgesia.After surgery, NRS scores of the patients will be evaluated (in the recovery room, 1,2,6,12 and 24 hours.
Preoperative anxiety, postoperative discharge time and analgesic consumption of all patients will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gallbladder surgerysurgery patients who will be operated under general anesthesia.
Key inclusion criteria (2 listed)
- Planned to gall bladder surgery
- An American Society of Anesthesiologists score of 1,2 or 3
Key exclusion criteria (4 listed)
- Severe cardiovascular disease
- Respiratory disease
- Psychiatric disease
- Those who have chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Opioid consumption
Time frame: During postoperative up to 24 hours
NRS
Time frame: During postoperative up to 24 hour
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 3 Oct 2022.
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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?
An observational study of Analgesia and Breathing, run by Tokat Gaziosmanpasa 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 2 inclusion and 4 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 3 Oct 2022. 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. 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?
Opioid consumption (time frame: During postoperative up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2022.