Postoperative PainNCT03623399
Laparoscopic Gas Pressure and Postoperative Pain Score
A study testing low gas pressure laparoscopy in people with Postoperative Pain and Laparoscopy, run by Seda Yuksel Simsek at 1 site in Turkey (Türkiye).
Trial summary
Aim of the study is to determine the effect of different laparoscopic intraoperative intraabdominal gas (CO2) pressures on the extent of postoperative pain scores. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Laparoscopy
- What is being tested?
- low gas pressure laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Aug 2018to May 2019
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- benign gynecologic pathologies which requires laparoscopic surgery
Who cannot join
- patients who has malign gynecologic pathologies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Seda Yuksel Simsek
Adana, 001
Erhan Simsek, Ass. Prof., +905334146299, drsimsekerhan@hotmail.com
Husnu Celik, Prof., +905323257093, drhusnucelik@gmail.com
About this study
Official title: Does Laparoscopic Entrance and Intraoperative Intraabdominal Gas Pressure Effect Postoperative Pain Score
Aim of the study is to determine the effect of different laparoscopic intraoperative intraabdominal gas (CO2) pressures on the extent of postoperative pain scores.
Read the detailed description
In this study investigator planned to randomize patients into three groups ; in the first group abdominal entrance pressure will be 15 mmhg and intraoperative pressure will be 15 mmhg too ; in the second group again entrance pressure will be 15 mmhg , intraoperative pressure will be 12 mmhg ; and in the thirth group both entrance and intraoperative pressures will be 12 mmhg. During operation intraoperative mean pressures will be recorded every 15 minutes , also end tidal CO2 pressures will also assesed by the anesthesiologist. Every participant will take , same standard analgesics ; 2 mg/kg contramal and 1 gr i.v. paracetamol at the end of the operation ; except the ones who has allergy to these analgesics. At postoperative 6 th and 24 th hours patients will be asked to execute the visual analogue score (VAS) form to assess the pain . Only patients with benign gynecologic pathologies will be included in to the study and informed consent forms will be taken from all participants.
- Conditions
- Postoperative Pain, Laparoscopy
- Being tested
- low gas pressure laparoscopy
- Keywords
- postoperative pain, Intraabdominal laparoscopic gas pressure
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low gas pressure laparoscopyProcedure or surgery
To apply different CO2 entrance and intraoperative pressures
| Study group | Role | What they receive |
|---|---|---|
| 15 mmhg-15mmhg | No intervention | Abdominal entrance pressure will be set to 15 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 15 mmhg. |
| 15 mmhg-12 mmhg | Other | Abdominal entrance pressure will be set to 15 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 12 mmhg.
Low gas pressure laparoscopy Receives: Procedure: low gas pressure laparoscopy |
| 12 mmhg-12 mmhg | Other | Abdominal entrance pressure will be set to 12 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 12 mmhg.
Low gas pressure laparoscopy Receives: Procedure: low gas pressure laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain scores
Difference between pain scores of participitants according to differing gas pressures applied.
Measured: Postoperative 6 th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start7 Aug 2018
- Primary completionMar 2019 (estimated)
- Study completionMay 2019 (estimated)
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 Postoperative PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seda Yuksel Simsek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seda Yuksel Simsek, Baskent University
- Investigators
- Husnu Celık, Prof., Study chair, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623399
- Sponsor's protocol ID
- Baskent University
- Status last verified
- Aug 2018
- First submitted
- 5 Aug 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: primary outcomes of the study
Publications
Koc M, Ertan T, Tez M, Kocpinar MA, Kilic M, Gocmen E, Aslar AK. Randomized, prospective comparison of postoperative pain in low- versus high-pressure pneumoperitoneum. ANZ J Surg. 2005 Aug;75(8):693-6. doi: 10.1111/j.1445-2197.2005.03496.x.
PubMed 16076335
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Laparoscopic Entrance and Intraoperative Intraabdominal Gas Pressure Effect Postoperative Pain Score
- ClinicalTrials.gov ID
- NCT03623399
- Acronym / sponsor ID
- Baskent University
- Conditions
- Postoperative Pain, Laparoscopy
- Keywords
- postoperative pain, Intraabdominal laparoscopic gas pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Seda Yuksel SimsekUniversity, hospital or other
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 9 Aug 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.
Aim of the study is to determine the effect of different laparoscopic intraoperative intraabdominal gas (CO2) pressures on the extent of postoperative pain scores.
Detailed description
In this study investigator planned to randomize patients into three groups ; in the first group abdominal entrance pressure will be 15 mmhg and intraoperative pressure will be 15 mmhg too ; in the second group again entrance pressure will be 15 mmhg , intraoperative pressure will be 12 mmhg ; and in the thirth group both entrance and intraoperative pressures will be 12 mmhg. During operation intraoperative mean pressures will be recorded every 15 minutes , also end tidal CO2 pressures will also assesed by the anesthesiologist. Every participant will take , same standard analgesics ; 2 mg/kg contramal and 1 gr i.v. paracetamol at the end of the operation ; except the ones who has allergy to these analgesics. At postoperative 6 th and 24 th hours patients will be asked to execute the visual analogue score (VAS) form to assess the pain . Only patients with benign gynecologic pathologies will be included in to the study and informed consent forms will be taken from all participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15 mmhg-15mmhg | No intervention | –Abdominal entrance pressure will be set to 15 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 15 mmhg. |
| 15 mmhg-12 mmhg | Other | Procedure: low gas pressure laparoscopyAbdominal entrance pressure will be set to 15 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 12 mmhg. Low gas pressure laparoscopy |
| 12 mmhg-12 mmhg | Other | Procedure: low gas pressure laparoscopyAbdominal entrance pressure will be set to 12 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 12 mmhg. Low gas pressure laparoscopy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- benign gynecologic pathologies which requires laparoscopic surgery
Key exclusion criteria (1 listed)
- patients who has malign gynecologic pathologies
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 |
|---|---|---|
| low gas pressure laparoscopyTo apply different CO2 entrance and intraoperative pressures | Procedure or surgery | 12 mmhg-12 mmhg, 15 mmhg-12 mmhg |
Primary outcome
postoperative pain scores
Time frame: Postoperative 6 th hour
Difference between pain scores of participitants according to differing gas pressures applied.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Background: PubMed 16076335Koc M, Ertan T, Tez M, Kocpinar MA, Kilic M, Gocmen E, Aslar AK. Randomized, prospective comparison of postoperative pain in low- versus high-pressure pneumoperitoneum. ANZ J Surg. 2005 Aug;75(8):693-6. doi: 10.1111/j.1445-2197.2005.03496.x.
- Individual participant dataSharing planned: Undecided. primary outcomes 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.
Husnu Celık, Prof. study chair
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low gas pressure laparoscopy in people with Postoperative Pain and Laparoscopy, run by Seda Yuksel Simsek 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: status not confirmed, as of the sponsor's last update on 9 Aug 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seda YUKSEL SIMSEK, M.D. (+905359112244, dryukselseda@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain scores (time frame: Postoperative 6 th 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 NCT03623399, 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 9 Aug 2018.