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NCT Number: NCT05253300

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. Pain Region

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

    Description of pain region as

    • Right shoulder
    • Left shoulder
    • Both shoulder
    • Back
    • Incision
    • Other

  3. 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

  4. Pain Region

    Time frame: postoperative 6th hour

    Description of pain region as

    • Right shoulder
    • Left shoulder
    • Both shoulder
    • Back
    • Incision
    • Other

  5. 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

  6. Pain Region

    Time frame: postoperative 12th hour

    Description of pain region as

    • Right shoulder
    • Left shoulder
    • Both shoulder
    • Back
    • Incision
    • Other

Secondary outcomes

  1. Use Analgesia

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

    Number of Analgesia used to reduce pain since arrival

  2. Use Analgesia

    Time frame: postoperative 6th hour

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

  3. Use Analgesia

    Time frame: postoperative 12th hour

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

Other outcomes

  1. patient's satisfaction with the given position

    Time frame: postoperative 12th hour

    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

Sponsors and collaborators

Lead sponsor

Sibel Yilmaz Sahin

Other

Registry information

Official study title

Laparoskopik Kolesistektomi Ameliyatı Sonrası Omuz Ağrısının Giderilmesinde Semi Rekümbent Pozisyonunun Etkisi

Acronym: SRPSP

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2022
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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