Shoulder PainSRPSPNCT05253300

Effect of Semi-recumbent Position on Treatment of Shoulder Pain Seen After Laparoscopic Cholecystectomy

A study testing Positioning the patient in people with Shoulder Pain, run by Sibel Yilmaz Sahin at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study was carried out to determine the effect of placing the semi-recumbent position in reducing pain in patients who developed shoulder pain after laparoscopic cholecystectomy. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Shoulder Pain
What is being tested?: Positioning the patient
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 14 Apr 2021to 24 Jul 2021
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Those who had surgery with laparoscopic cholecystectomy
Those between the ages of 18-65,
Patients in ASA I-II group
Patients undergoing general anesthesia

Who cannot join

Epidural analgesia after surgery
Patients with reactive airway diseases such as chronic obstructive pulmonary disease (COPD), Bronchitis, Emphysema
Conversion to open abdominal surgery during laparoscopic cholecystectomy

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

University of Health Sciences
Ankara, 06010

Other trials in Turkey (Türkiye)

About this study

Official title: Laparoskopik Kolesistektomi Ameliyatı Sonrası Omuz Ağrısının Giderilmesinde Semi Rekümbent Pozisyonunun Etkisi

This study was carried out to determine the effect of placing the semi-recumbent position in reducing pain in patients who developed shoulder pain after laparoscopic cholecystectomy.

HO: The application of the semi-recumbent position to patients who develop shoulder pain after laparoscopic cholecystectomy has no effect on reducing pain.

H1: The application of semi-recumbent position in patients who develop shoulder pain after laparoscopic cholecystectomy has an effect on reducing pain.

Read the detailed description

In addition to pharmacological interventions for the relief of postoperative complications such as pain in patients undergoing laparoscopic cholecystectomy, non-pharmacological applications; It is evaluated that it will be beneficial in increasing patient satisfaction, reducing the need for analgesic drugs, reducing the cost of hospitalization due to the side effects of drugs and increasing the quality of care. With the results of this research, it is evaluated that the effect of positioning, which is one of the independent activities of nurses who base their care on evidence-based practices, on pain will be beneficial to increase the evidence-based nursing knowledge in the literature.

Conditions: Shoulder Pain
Being tested: Positioning the patient
Keywords: laparoscopic cholecystectomy, shoulder pain, semi-recumbent position, pain
Medical subject headings: Shoulder Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Positioning the patientOther
The patients' vital signs, pain and analgesic drug use were recorded in the "Pain Follow-up Form" at the time they came to the clinic, at the 6th and 12th hours after the surgery, by recording from the end-of-operation file. In case the patient had pain, the time when the pain started was recorded, the experimental group was given the semi-recumbent position with analgesic drug and the patient was asked to maintain this position for 2 hours. If the patient has pain again, this position is given again. "Patient Satisfaction Evaluation Form" was filled in at the 12th hour after the surgery for the patients in the experimental group.

Study groups in NCT05253300
Study group	Role	What they receive
Semi Recumbent	Experimental	The patients' vital signs, pain and analgesic drug use were recorded in the "Pain Follow-up Form" at the time they came to the clinic, at the 6th and 12th hours after the surgery, by recording from the end-of-operation file. In case the patient had pain, the time when the pain started was recorded, the experimental group was given the semi-recumbent position with analgesic drug and the patient was asked to maintain this position for 2 hours. If the patient has pain again, this position is given again. "Patient Satisfaction Evaluation Form" was filled in at the 12th hour after the surgery for the patients in the experimental group. Receives: Other: Positioning the patient
Control	No intervention	The patients' vital signs, pain and analgesic drug use were recorded in the "Pain Follow-up Form" at the time they came to the clinic, at the 6th and 12th hours after the surgery, by recording from the end-of-operation file. In case the patient has pain, the time when the patients' pain started was recorded, and only analgesic medication was administered to the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Severity
Pain evaluated with numerical rating scale (NRS). A numerical rating scale requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
Measured: arrival time at the clinic (approximately the first two hours postoperatively)
Pain Region
Description of pain region as
1. Right shoulder
2. Left shoulder
3. Both shoulder
4. Back
5. Incision
6. Other
Measured: arrival time at the clinic (approximately the first two hours postoperatively)
Pain Severity
Pain evaluated with numerical rating scale (NRS). A numerical rating scale requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
Measured: postoperative 6th hour
Pain Region
Description of pain region as
1. Right shoulder
2. Left shoulder
3. Both shoulder
4. Back
5. Incision
6. Other
Measured: postoperative 6th hour
Pain Severity
Pain evaluated with numerical rating scale (NRS). A numerical rating scale requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
Measured: postoperative 12th hour
Pain Region
Description of pain region as
1. Right shoulder
2. Left shoulder
3. Both shoulder
4. Back
5. Incision
6. Other
Measured: postoperative 12th hour

Secondary outcomes (3)

Use Analgesia
Number of Analgesia used to reduce pain since arrival
Measured: postoperatarrival time at the clinic (approximately the first two hours postoperatively)
Use Analgesia
Number of Analgesia used to reduce pain between arrival time and 6th hour
Measured: postoperative 6th hour
Use Analgesia
Number of Analgesia used to reduce pain between 6th hour and 12th hour
Measured: postoperative 12th hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Apr 202124 Jul 2021

First posted23 Feb 2022
Study start14 Apr 2021
Primary completion24 Jul 2021
Study completion24 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Shoulder 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: Non-randomised
Intervention model: Crossover
Model description: The type of this study is a quasi-experimental clinical study.
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05253300
Sponsor's protocol ID: SRPShoulderPain
Acronym: SRPSP
Status last verified: Feb 2022
First submitted: 12 Jan 2022
Last updated: 23 Feb 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.
PubMed 18448749
Pasquier EK, Andersson E. Pulmonary recruitment maneuver reduces pain after laparoscopic bariatric surgery: a randomized controlled clinical trial. Surg Obes Relat Dis. 2018 Mar;14(3):386-392. doi: 10.1016/j.soard.2017.11.017. Epub 2017 Nov 22.
PubMed 29290563
Aydemir O, Aslan FE, Karabacak U, Akdas O. The Effect of Exaggerated Lithotomy Position on Shoulder Pain after Laparoscopic Cholecystectomy. Pain Manag Nurs. 2018 Dec;19(6):663-670. doi: 10.1016/j.pmn.2018.04.012. Epub 2018 Jun 19.
PubMed 29934129

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain

All Shoulder Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Laparoskopik Kolesistektomi Ameliyatı Sonrası Omuz Ağrısının Giderilmesinde Semi Rekümbent Pozisyonunun Etkisi
ClinicalTrials.gov ID: NCT05253300
Acronym / sponsor ID: SRPSP / SRPShoulderPain
Conditions: Shoulder Pain
Keywords: laparoscopic cholecystectomy, shoulder pain, semi-recumbent position, pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Sibel Yilmaz SahinUniversity, hospital or other
Study start: 14 Apr 2021 (actual)
Primary completion: 24 Jul 2021 (actual)
Study completion: 24 Jul 2021 (actual)
First posted: 23 Feb 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.

This study was carried out to determine the effect of placing the semi-recumbent position in reducing pain in patients who developed shoulder pain after laparoscopic cholecystectomy.

HO: The application of the semi-recumbent position to patients who develop shoulder pain after laparoscopic cholecystectomy has no effect on reducing pain.

H1: The application of semi-recumbent position in patients who develop shoulder pain after laparoscopic cholecystectomy has an effect on reducing pain.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: The type of this study is a quasi-experimental clinical study.

Arm	Type	Receives
Semi Recumbent	Experimental	Other: Positioning the patientThe patients' vital signs, pain and analgesic drug use were recorded in the "Pain Follow-up Form" at the time they came to the clinic, at the 6th and 12th hours after the surgery, by recording from the end-of-operation file. In case the patient had pain, the time when the pain started was recorded, the experimental group was given the semi-recumbent position with analgesic drug and the patient was asked to maintain this position for 2 hours. If the patient has pain again, this position is given again. "Patient Satisfaction Evaluation Form" was filled in at the 12th hour after the surgery for the patients in the experimental group.
Control	No intervention	–The patients' vital signs, pain and analgesic drug use were recorded in the "Pain Follow-up Form" at the time they came to the clinic, at the 6th and 12th hours after the surgery, by recording from the end-of-operation file. In case the patient has pain, the time when the patients' pain started was recorded, and only analgesic medication was administered to the control group.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Those who had surgery with laparoscopic cholecystectomy
Those between the ages of 18-65,
Patients in ASA I-II group
Patients undergoing general anesthesia

Key exclusion criteria (3 listed)

Epidural analgesia after surgery
Patients with reactive airway diseases such as chronic obstructive pulmonary disease (COPD), Bronchitis, Emphysema
Conversion to open abdominal surgery during laparoscopic cholecystectomy

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
Positioning the patientThe patients' vital signs, pain and analgesic drug use were recorded in the "Pain Follow-up Form" at the time they came to the clinic, at the 6th and 12th hours after the surgery, by recording from the end-of-operation file. In case the patient had pain, the time when the pain started was recorded, the experimental group was given the semi-recumbent position with analgesic drug and the patient was asked to maintain this position for 2 hours. If the patient has pain again, this position is given again. "Patient Satisfaction Evaluation Form" was filled in at the 12th hour after the surgery for the patients in the experimental group.	Other	Semi Recumbent

Primary outcome

Pain Severity
Time frame: arrival time at the clinic (approximately the first two hours postoperatively)
Pain evaluated with numerical rating scale (NRS). A numerical rating scale requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
Pain Region
Time frame: arrival time at the clinic (approximately the first two hours postoperatively)
Description of pain region as 1. Right shoulder 2. Left shoulder 3. Both shoulder 4. Back 5. Incision 6. Other
Pain Severity
Time frame: postoperative 6th hour
Pain evaluated with numerical rating scale (NRS). A numerical rating scale requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
Pain Region
Time frame: postoperative 6th hour
Description of pain region as 1. Right shoulder 2. Left shoulder 3. Both shoulder 4. Back 5. Incision 6. Other
Pain Severity
Time frame: postoperative 12th hour
Pain evaluated with numerical rating scale (NRS). A numerical rating scale requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
Pain Region
Time frame: postoperative 12th hour
Description of pain region as 1. Right shoulder 2. Left shoulder 3. Both shoulder 4. Back 5. Incision 6. Other

3 secondary outcomes

Use Analgesia
Time frame: postoperatarrival time at the clinic (approximately the first two hours postoperatively)
Use Analgesia
Time frame: postoperative 6th hour
Use Analgesia
Time frame: postoperative 12th 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 23 Feb 2022.
Background: PubMed 18448749Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.
Background: PubMed 29290563Pasquier EK, Andersson E. Pulmonary recruitment maneuver reduces pain after laparoscopic bariatric surgery: a randomized controlled clinical trial. Surg Obes Relat Dis. 2018 Mar;14(3):386-392. doi: 10.1016/j.soard.2017.11.017. Epub 2017 Nov 22.
Background: PubMed 29934129Aydemir O, Aslan FE, Karabacak U, Akdas O. The Effect of Exaggerated Lithotomy Position on Shoulder Pain after Laparoscopic Cholecystectomy. Pain Manag Nurs. 2018 Dec;19(6):663-670. doi: 10.1016/j.pmn.2018.04.012. Epub 2018 Jun 19.

Related trials for Shoulder Pain

Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain

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.

Sibel YILMAZ SAHIN, Asst. Prof. study chair

Gulhane Faculty of Nursing, University of Health Sciences, Ankara, Turkey

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Positioning the patient in people with Shoulder Pain, run by Sibel Yilmaz Sahin 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 4 inclusion and 3 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 23 Feb 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?

Pain Severity (time frame: arrival time at the clinic (approximately the first two hours postoperatively)). The study lists 6 primary outcomes in all. 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 NCT05253300, which also lists 3 linked publications.

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 23 Feb 2022.