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

NCT05253300 | Completed DMC

• 1 other identifier: SRPShoulderPain
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Keywords

laparoscopic cholecystectomy; shoulder pain; semi-recumbent position; pain

Outcome Measures

Primary Outcomes (6)

• 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)

• Pain Region

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

  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

  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

  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

  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

  postoperative 12th hour

Secondary Outcomes (3)

• Use Analgesia

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

• Use Analgesia

  postoperative 6th hour

• Use Analgesia

  postoperative 12th hour

Other Outcomes (1)

• patient's satisfaction with the given position

  postoperative 12th hour

Study Arms (2)

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.

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.

Interventions

Positioning the patient OTHER

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.

Semi Recumbent

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sibel Yilmaz Sahin: lead

Study Sites (1)

University of Health Sciences

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 18448749 BACKGROUND

• 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.

  PMID: 29290563 BACKGROUND

• 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.

  PMID: 29934129 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sibel YILMAZ SAHIN, Asst. Prof.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Model Details: The type of this study is a quasi-experimental clinical study.

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 23, 2022
• Study Start: April 14, 2021
• Primary Completion: July 24, 2021
• Study Completion: July 24, 2021
• Last Updated: February 23, 2022

Record last verified: 2022-02

Locations

TU (1)