search
Back to results

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

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Positioning the patient
Sponsored by
Sibel Yilmaz Sahin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Shoulder Pain focused on measuring laparoscopic cholecystectomy, shoulder pain, semi-recumbent position, pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Semi Recumbent

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
Pain Region
Description of pain region as Right shoulder Left shoulder Both shoulder Back Incision Other
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
Pain Region
Description of pain region as Right shoulder Left shoulder Both shoulder Back Incision Other
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
Pain Region
Description of pain region as Right shoulder Left shoulder Both shoulder Back Incision Other

Secondary Outcome Measures

Use Analgesia
Number of Analgesia used to reduce pain since arrival
Use Analgesia
Number of Analgesia used to reduce pain between arrival time and 6th hour
Use Analgesia
Number of Analgesia used to reduce pain between 6th hour and 12th hour

Full Information

First Posted
January 12, 2022
Last Updated
February 11, 2022
Sponsor
Sibel Yilmaz Sahin
search

1. Study Identification

Unique Protocol Identification Number
NCT05253300
Brief Title
Effect of Semi-recumbent Position on Treatment of Shoulder Pain Seen After Laparoscopic Cholecystectomy
Acronym
SRPSP
Official Title
Laparoskopik Kolesistektomi Ameliyatı Sonrası Omuz Ağrısının Giderilmesinde Semi Rekümbent Pozisyonunun Etkisi
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
July 24, 2021 (Actual)
Study Completion Date
July 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sibel Yilmaz Sahin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
laparoscopic cholecystectomy, shoulder pain, semi-recumbent position, pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The type of this study is a quasi-experimental clinical study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semi Recumbent
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Positioning the patient
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Severity
Description
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)
Title
Pain Region
Description
Description of pain region as Right shoulder Left shoulder Both shoulder Back Incision Other
Time Frame
arrival time at the clinic (approximately the first two hours postoperatively)
Title
Pain Severity
Description
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
Title
Pain Region
Description
Description of pain region as Right shoulder Left shoulder Both shoulder Back Incision Other
Time Frame
postoperative 6th hour
Title
Pain Severity
Description
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
Title
Pain Region
Description
Description of pain region as Right shoulder Left shoulder Both shoulder Back Incision Other
Time Frame
postoperative 12th hour
Secondary Outcome Measure Information:
Title
Use Analgesia
Description
Number of Analgesia used to reduce pain since arrival
Time Frame
postoperatarrival time at the clinic (approximately the first two hours postoperatively)
Title
Use Analgesia
Description
Number of Analgesia used to reduce pain between arrival time and 6th hour
Time Frame
postoperative 6th hour
Title
Use Analgesia
Description
Number of Analgesia used to reduce pain between 6th hour and 12th hour
Time Frame
postoperative 12th hour
Other Pre-specified Outcome Measures:
Title
patient's satisfaction with the given position
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sibel YILMAZ SAHIN, Asst. Prof.
Organizational Affiliation
Gulhane Faculty of Nursing, University of Health Sciences, Ankara, Turkey
Official's Role
Study Chair
Facility Information:
Facility Name
University of Health Sciences
City
Ankara
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
18448749
Citation
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.
Results Reference
background
PubMed Identifier
29290563
Citation
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.
Results Reference
background
PubMed Identifier
29934129
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs