Postoperative PainNCT05784493
Pain After Laparoscopic Hysterectomy
A study testing Study group in people with Postoperative Pain, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The investigators evaluated postoperative pain after total laparoscopic hysterectomy. Two arm are evaluated. During laparoscopic hysterectomy, in one arm; abdominal cavity was washed by saline at normal room temperature. In another arm; abdominal cavity was washed heated saline . Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Study group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 30 Dec 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all of cases that had laparoscopic hysterectomy for bening conditions
Who cannot join
- maling cases
- conversion to laparotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intraabdominal Saline Washing After Laparoscopic Hysterectomy on Postoperative Pain: Double Blind Randomized Controlled Study
The investigators evaluated postoperative pain after total laparoscopic hysterectomy. Two arm are evaluated. During laparoscopic hysterectomy, in one arm; abdominal cavity was washed by saline at normal room temperature. In another arm; abdominal cavity was washed heated saline . Postoperative pain was evaluated by using visual analogy scale.
Read the detailed description
The aim of this study was evaluated the effect of washing abdominal cavity by heated or normal temperature saline on postoperative pain.
This study is double blind randomized controlled study.
inclusion criteria: all of cases that had laparoscopic hysterectomy for bening condition
exclusion criteria: maling cases and conversion to laparotomy
after randomization and completion of surgery, investigator was evaluated postoperative pain at 0-4-8 th hours by using visual analog scale participants and investigator were blinded .
- Conditions
- Postoperative Pain
- Being tested
- Study group
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study groupOther
Washing by heated saline group
| Study group | Role | What they receive |
|---|---|---|
| Washing by heated saline group | Experimental | Not described Receives: Other: Study group |
| Washing by normal room temperature saline group | Active comparator | Not described Receives: Other: Study group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed by visual analog scale
To assess postoperative pain incidence by using visual analog scale
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Jul 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Collaborators
- Fırat Can Sogut, Ozlem Sevinc Ergul, Mehmet Veysel Arın
- Responsible party
- Principal investigator, Mehmet Baki Senturk, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784493
- Sponsor's protocol ID
- 2020.04.06.02
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 27 Mar 2023
- 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 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraabdominal Saline Washing After Laparoscopic Hysterectomy on Postoperative Pain: Double Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05784493
- Acronym / sponsor ID
- 2020.04.06.02
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Collaborators
- Fırat Can Sogut, Ozlem Sevinc Ergul, Mehmet Veysel Arın
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 27 Mar 2023 (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 investigators evaluated postoperative pain after total laparoscopic hysterectomy. Two arm are evaluated. During laparoscopic hysterectomy, in one arm; abdominal cavity was washed by saline at normal room temperature. In another arm; abdominal cavity was washed heated saline . Postoperative pain was evaluated by using visual analogy scale.
Detailed description
The aim of this study was evaluated the effect of washing abdominal cavity by heated or normal temperature saline on postoperative pain.
This study is double blind randomized controlled study.
inclusion criteria: all of cases that had laparoscopic hysterectomy for bening condition
exclusion criteria: maling cases and conversion to laparotomy
after randomization and completion of surgery, investigator was evaluated postoperative pain at 0-4-8 th hours by using visual analog scale participants and investigator were blinded .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Washing by heated saline group | Experimental | Other: Study group |
| Washing by normal room temperature saline group | Active comparator | Other: Study group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all of cases that had laparoscopic hysterectomy for bening conditions
Key exclusion criteria (2 listed)
- maling cases
- conversion to laparotomy
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 |
|---|---|---|
| Study groupWashing by heated saline group | Other | Washing by heated saline group, Washing by normal room temperature saline group |
Primary outcome
Pain assessed by visual analog scale
Time frame: 5 months
To assess postoperative pain incidence by using visual analog scale
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 27 Mar 2023.
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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 Study group in people with Postoperative Pain, run by Namik Kemal 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 2 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 27 Mar 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 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?
Pain assessed by visual analog scale (time frame: 5 months). 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 27 Mar 2023.