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OpenTrials
Completed

NCT Number: NCT05489796

Bellomic PCA in Laparoscopic Gynecologic Surgery

In laparoscopic gynecological surgery, when intravenous patient-controlled analgesia (IV-PCA) device is used after surgery, the degree of postoperative side effects and pain control is compared when a combination of fentanyl and ketorolac is administered compared to when fentanyl alone is used.

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Key information

Conditions

Laparoscopic Gynecological Surgery

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National Univ. Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American society of anesthesiology physical status 1 or 2
  • Patients scheduled for gynecological laparoscopic surgery under general anesthesia
  • Patients who applied for the use of IV-PCA after surgery

Exclusion criteria

  • Patients with side effects of opioids
  • Patients with hypersensitivity to aspirin or non-steroid anti-inflammatory drugs
  • Patients with alcohol or drug dependence
  • Patients with peptic ulcers, patients with gastrointestinal bleeding
  • Patients with suspected cerebrovascular hemorrhage, organic disorders, or damage to the head related to increased intracranial pressure
  • Symptoms of bronchial asthma or bronchospasm
  • Patients with severe respiratory depression
  • Moderate to severe renal impairment
  • Patients with reduced blood volume or dehydration
  • polyps in the nose
  • angioedema
  • Patients with or a history of the convulsive disease
  • Patients for whom the use of neuromuscular blocking agents is contraindicated

Treatment and study plan

Fentanyl selector

Drug

Selector (1 ml; Lock out 10 min): Fentanyl 200 mcg + N/S 16 ml = total 20 ml

Fentanyl continuous

Drug

Continuous (2 ml/hr): fentanyl 700 mcg + N/S 86 ml = total 100 ml

Ketorolac continuous

Drug

Continuous (2 ml/hr): Ketorolac 180 mg + N/S 94 ml = total 100 ml

Primary outcomes

  1. Change in the occurrence of postoperative nausea

    Time frame: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour

    Confirm the occurrence of postoperative nausea.

  2. Change in the occurrence of postoperative vomiting

    Time frame: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour

    Confirm the occurrence of postoperative vomiting.

Secondary outcomes

  1. Change in the use of rescue antiemetics

    Time frame: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour

    Investigate the use of rescue antiemetics.

  2. Change of postoperative pain score

    Time frame: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour

    Postoperative pain scores are scored on a scale of 0-10.

  3. Change in the use of rescue analgesics

    Time frame: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour

    Investigate the use of rescue analgesics.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Comparison of Postoperative Side Effects and Analgesic Quality According to the Combination of Fentanyl and Ketorolac Versus Fentanyl After Laparoscopic Gynecologic Surgery

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2022
Registry last updated
May 18, 2023

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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