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CompletedNCT05253300SRPSPUpdated Feb 23, 2022

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

An interventional study of Positioning the patient in Shoulder Pain, sponsored by Sibel Yilmaz Sahin. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-02-23.

Sponsored by Sibel Yilmaz Sahin · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Apr 2021, registered Jan 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Shoulder Pain

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Keywords

  • laparoscopic cholecystectomy
  • shoulder pain
  • semi-recumbent position
  • pain
03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 70 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Sibel Yilmaz Sahin is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Semi Recumbent

    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.

    Other: Positioning the patient

  • No intervention
    Control

    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.

Interventions

  • OtherPositioning the patient

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: arrival time at the clinic (approximately the first two hours postoperatively)

  2. Pain Region

    Description of pain region as 1. Right shoulder 2. Left shoulder 3. Both shoulder 4. Back 5. Incision 6. Other

    Time frame: arrival time at the clinic (approximately the first two hours postoperatively)

  3. 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

    Time frame: postoperative 6th hour

  4. Pain Region

    Description of pain region as 1. Right shoulder 2. Left shoulder 3. Both shoulder 4. Back 5. Incision 6. Other

    Time frame: postoperative 6th hour

  5. 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

    Time frame: postoperative 12th hour

  6. Pain Region

    Description of pain region as 1. Right shoulder 2. Left shoulder 3. Both shoulder 4. Back 5. Incision 6. Other

    Time frame: postoperative 12th hour

Secondary outcomes

  1. Use Analgesia

    Number of Analgesia used to reduce pain since arrival

    Time frame: postoperatarrival time at the clinic (approximately the first two hours postoperatively)

  2. Use Analgesia

    Number of Analgesia used to reduce pain between arrival time and 6th hour

    Time frame: postoperative 6th hour

  3. Use Analgesia

    Number of Analgesia used to reduce pain between 6th hour and 12th hour

    Time frame: postoperative 12th hour

Other outcomes

  1. patient's satisfaction with the given position

    Used Yes or No question to evaluate if patient were satisfied with the semi-recumbent position to prevent post-operative shoulder pain and Whether they think the semi-recumbent position is beneficial. Numerical rating scale (NRS) were used to evaluate how satisfied they are with the semi-recumbent position to avoid surgery-related shoulder pain and How much discomfort they felt during their stay in the semi-recumbent position. NRS of 0 to10 were used and rated as 0 is not at all and 10 is very much

    Time frame: postoperative 12th hour

07

Study locations

1 site
  • University of Health Sciences
    Ankara, 06010, Turkey
08

References and documents

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. Erratum In: Pain Manag Nurs. 2019 Feb;20(1):89. doi: 10.1016/j.pmn.2019.01.002. PubMed 29934129 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05253300
Lead sponsor
Sibel Yilmaz Sahin
Responsible party
Sibel Yilmaz Sahin (Assistant professor, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi) — Sponsor-investigator
First posted
Feb 23, 2022
Start date
Apr 14, 2021
Primary completion
Jul 24, 2021
Completion
Jul 24, 2021
Last update
Feb 23, 2022

Study contacts

Sibel YILMAZ SAHIN, Asst. Prof.
study chair · Gulhane Faculty of Nursing, University of Health Sciences, Ankara, Turkey

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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