Post Operative PainNCT05428982
The Effect of Postoperative Modified Trendelenburg Position to Decrease Shoulder Pain After Laparoscopic Hysterectomy: A Randomized Controlled Trial
A study testing Postoperative Modified Trendelenburg position in people with Post Operative Pain and Shoulder Pain, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Laparoscopic surgery is commonly used procedure in diagnostic and treatment including Hysterectomy. Post laparoscopic shoulder pain is common side effect mostly occur after surgery. Postoperative Trendelenburg position might decrease pain by reducing the mechanical pressure of CO2 on the diaphragm. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Shoulder Pain, Gynecologic Disease
- What is being tested?
- Postoperative Modified Trendelenburg position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteThailand
- Study dates
- 30 Jun 2022to 30 Aug 2023
- 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patient age between 30-65 years
- American Society of Anesthesiologist (ASA) physical status I or II
- Scheduled for operative laparoscopic hysterectomy with abdominal incisions measuring less than 1 cm in size
- Can speak and understand Thai language
Who cannot join
- Pregnant women
- Conversion procedure to open abdominal surgery
- Patients with postoperative abdominal drainage
- Surgery duration more than 3 hours
- Gynecologic malignancy surgery
- Patients with history of chronic shoulder pain
Show all 21Show fewer
- Patients with history of previous shoulder surgery
- Inability to accurately express pain
- Patients with history of Gastroesophageal reflux disease or chronic gastritis
- Patients with history of cardiovascular or pulmonary disease
- Patients with history of venous thrombosis
- Morbid obesity BMI > 40 kg/m2
- Patients with history of increase intracranial pressure
- Patients with history of increase intraocular pressure
- Patients with liver and/or kidney disease
- NSAIDs and/or Paracetamol and/or Morphine allergy
- Current corticosteroid use
- Patients who use current analgesic drugs and don't want to quit while stay in the hospital
- Psychiatric disorder
- Intellectual disorder
- Postoperative length in hospital less than 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Laparoscopic surgery is commonly used procedure in diagnostic and treatment including Hysterectomy. Post laparoscopic shoulder pain is common side effect mostly occur after surgery. Postoperative Trendelenburg position might decrease pain by reducing the mechanical pressure of CO2 on the diaphragm. Maintaining the patient in Trendelenburg for 6 hours postoperatively will decrease postoperative shoulder pain.
Read the detailed description
After laparoscopic hysterectomy surgery, Patients in intervention group were positioned in a Modified Trendelenburg position (20 °) postoperative for 6 hours because of the limitation of this study cannot positioned in Trendelenburg position.
A modified Trendelenburg position is head and trunk of patient were in neutral position while hips and lower extrimities were raised at 20 degree.
In control group were in neutral position. All patients were asked shoulder pain score at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
- Conditions
- Post Operative Pain, Shoulder Pain, Gynecologic Disease
- Being tested
- Postoperative Modified Trendelenburg position
- Keywords
- Modified Trendelenburg, Shoulder Pain, Laparoscopic hysterectomy
- Medical subject headings
- Pain, Postoperative, Shoulder Pain, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Modified Trendelenburg positionProcedure or surgery
Patients underwent the laparoscopic hysterectomy were positioned in a Modified Trendelenburg position (20 °) postoperative for 6 hours at ward.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Modified Trendelenburg group | Experimental | Patients underwent the laparoscopic hysterectomy were positioned in a Modified Trendelenburg position (20 °) postoperative for 6 hours Receives: Procedure: Postoperative Modified Trendelenburg position |
| Control | No intervention | Patients underwent the laparoscopic hysterectomy were positioned in a neutral position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of shoulder pain score
Comparison of shoulder pain score at 6 hours after postoperative Modified Trendelenburg position for 6 hours Using Numerical rating scale 0-10, 0 mean no pain, 10 mean worst pain
Measured: at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
Secondary outcomes (4)
Comparison of nausea vomiting score
Comparison of nausea vomiting score at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours Nausea vomiting score grading : 1. None mean no symptom, 2. Mild mean only nausea, not required antiemetic drugs 3.Moderate mean have symptom of nausea and vomiting and required antiemetic drugs 4.Severe mean have symptom of nausea and vomiting and required antiemetic drugs more than 1 time
Measured: at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
Total amount of antiemetic drugs in 24 hours postoperatively
Total amount of antiemetic drugs in 24 hours postoperatively
Measured: 24 hours postoperatively
Comparison of upper abdominal pain score
Comparison of upper abdominal pain score at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours Using Numerical rating scale 0-10, 0 mean no pain, 10 mean worst pain
Measured: at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
Comparison of lower abdominal pain score
Comparison of lower abdominal pain score at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours Using Numerical rating scale 0-10, 0 mean no pain, 10 mean worst pain
Measured: at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start30 Jun 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428982
- Sponsor's protocol ID
- 65055
- Status last verified
- Jul 2023
- First submitted
- 7 Jun 2022
- Last updated
- 18 Nov 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postoperative Modified Trendelenburg Position to Decrease Shoulder Pain After Laparoscopic Hysterectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05428982
- Acronym / sponsor ID
- 65055
- Conditions
- Post Operative Pain, Shoulder Pain, Gynecologic Disease
- Keywords
- Modified Trendelenburg, Shoulder Pain, Laparoscopic hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 23 Jun 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.
Laparoscopic surgery is commonly used procedure in diagnostic and treatment including Hysterectomy. Post laparoscopic shoulder pain is common side effect mostly occur after surgery. Postoperative Trendelenburg position might decrease pain by reducing the mechanical pressure of CO2 on the diaphragm. Maintaining the patient in Trendelenburg for 6 hours postoperatively will decrease postoperative shoulder pain.
Detailed description
After laparoscopic hysterectomy surgery, Patients in intervention group were positioned in a Modified Trendelenburg position (20 °) postoperative for 6 hours because of the limitation of this study cannot positioned in Trendelenburg position.
A modified Trendelenburg position is head and trunk of patient were in neutral position while hips and lower extrimities were raised at 20 degree.
In control group were in neutral position. All patients were asked shoulder pain score at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative Modified Trendelenburg group | Experimental | Procedure: Postoperative Modified Trendelenburg positionPatients underwent the laparoscopic hysterectomy were positioned in a Modified Trendelenburg position (20 °) postoperative for 6 hours |
| Control | No intervention | –Patients underwent the laparoscopic hysterectomy were positioned in a neutral position |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patient age between 30-65 years
- American Society of Anesthesiologist (ASA) physical status I or II
- Scheduled for operative laparoscopic hysterectomy with abdominal incisions measuring less than 1 cm in size
- Can speak and understand Thai language
Key exclusion criteria (21 listed)
- Pregnant women
- Conversion procedure to open abdominal surgery
- Patients with postoperative abdominal drainage
- Surgery duration more than 3 hours
- Gynecologic malignancy surgery
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 |
|---|---|---|
| Postoperative Modified Trendelenburg positionPatients underwent the laparoscopic hysterectomy were positioned in a Modified Trendelenburg position (20 °) postoperative for 6 hours at ward. | Procedure or surgery | Postoperative Modified Trendelenburg group |
Primary outcome
Comparison of shoulder pain score
Time frame: at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
Comparison of shoulder pain score at 6 hours after postoperative Modified Trendelenburg position for 6 hours Using Numerical rating scale 0-10, 0 mean no pain, 10 mean worst pain
4 secondary outcomes
Comparison of nausea vomiting score
Time frame: at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
Total amount of antiemetic drugs in 24 hours postoperatively
Time frame: 24 hours postoperatively
Comparison of upper abdominal pain score
Time frame: at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
Comparison of lower abdominal pain score
Time frame: at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
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 18 Nov 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 Postoperative Modified Trendelenburg position in people with Post Operative Pain and Shoulder Pain, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 4 inclusion and 21 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 18 Nov 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 Thailand. 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?
Comparison of shoulder pain score (time frame: at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours). 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 18 Nov 2023.