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

Shoulder Pain Clinical Trial

— SRPSP  

Official title:

Laparoskopik Kolesistektomi Ameliyatı Sonrası Omuz Ağrısının Giderilmesinde Semi Rekümbent Pozisyonunun Etkisi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05253300
• Other study ID #: SRPShoulderPain
• Status: Completed
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: July 24, 2021

Study information

• Verified date: February 2022
• Source: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 24, 2021
• Est. primary completion date: July 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Other:
• Positioning 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.

Locations

Country	Name	City	State
Turkey	University of Health Sciences	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Sibel Yilmaz Sahin

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Aydemir Ö, Aslan FE, Karabacak Ü, Akdas Ö. 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	postoperative 12th hour
Primary	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	arrival time at the clinic (approximately the first two hours postoperatively)
Primary	Pain Region	Description of pain region as; Right shoulder; Left shoulder; Both shoulder; Back; Incision; Other	arrival time at the clinic (approximately the first two hours postoperatively)
Primary	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	postoperative 6th hour
Primary	Pain Region	Description of pain region as; Right shoulder; Left shoulder; Both shoulder; Back; Incision; Other	postoperative 6th hour
Primary	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	postoperative 12th hour
Primary	Pain Region	Description of pain region as; Right shoulder; Left shoulder; Both shoulder; Back; Incision; Other	postoperative 12th hour
Secondary	Use Analgesia	Number of Analgesia used to reduce pain since arrival	postoperatarrival time at the clinic (approximately the first two hours postoperatively)
Secondary	Use Analgesia	Number of Analgesia used to reduce pain between arrival time and 6th hour	postoperative 6th hour
Secondary	Use Analgesia	Number of Analgesia used to reduce pain between 6th hour and 12th hour	postoperative 12th hour