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Completed

NCT Number: NCT04236323

The Effect of Remifentanil on Rebound Pain

The investigators will evaluate the influence of intraoperative remifentanil infusion on the postoperative hyperalgesia in patients receiving rotator cuff repair after brachial plexus block for postoperative analgesia.

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Key information

Conditions

Pain, Postoperative Hyperalgesia Nervous System Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jin-Tae Kim

Seoul, South Korea

About this study

The study will include 68 patients undergoing rotator cuff repair. All patients will receive brachial plexus block for postoperative analgesia, followed by general anesthesia. In the experimental group, remifentanil infusion will not be used intraoperatively, and in the control group, remifentanil will be infused. After surgery, both groups will be given the same postoperative pain management using patient controlled analgesia(PCA), and pain patterns will be assessed using the Numerical rating scale (NRS) at 4 hour intervals for 24 hours. The primary end point of this study is the total dose of PCA medication over 24 hours.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ASA class I,II,III
  • Patients undergoing arthroscopic rotator cuff repair surgery under general anesthesia after interscalen brachial plexus block for post operative analgesia
  • Age ranges from 20 to 70

Exclusion criteria

  • Patients who didn't agree to study
  • Patients can't control PCA(Patient-Controlled-Analgesia) independently
  • Patients who have conciousness disorder or can't express their pain level by NRS(Numeric Rating Scale) system
  • Patients who have severe respiratory disease or hepatic failure
  • Patinets who have known neuropathy or coagulopathy
  • Pregnancy
  • Patients with allegies to the drugs used in this study

Treatment and study plan

Not used remifentanil infusion

Drug

Remifentanil is not used during operation

Primary outcomes

  1. Total infused dose of patient controlled analgesia(PCA) drug during 24 hours

    Time frame: From end of operation to the 24hours after operation

    Total infused dose of patient controlled analgesia(PCA) drug during first 24 hours after rotor cuff repair under general anesthesia

Secondary outcomes

  1. Numerical Ratings Scale

    Time frame: Pain levels are checked using Numerical Ratings Scale at 4 hour intervals for 24 hours after surgery

    Degree of pain is assessed using Numerical Ratings Scale at 4 hours for 24 hours after operation. The patients choose one of the digits from 0 to 10, the zero-point is painless, and the ten-point means the one with the most severe pain.

  2. Total patient's trial to PCA bolus infusion

    Time frame: 24 hours after surgery

    The total number of times patients press the infusion button on the PCA to control pain

  3. Incidence of postoperative nausea and vomiting

    Time frame: 24 hours after surgery

    Postoperative nausea and vomiting is assessed at 24hr after surgery by a face-to face interview

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Effect of Remifentanil on Rebound Pain in Patients Receiving General Anesthesia for Shoulder Arthroplasty After Brachial Plexus Block for Postoperative Pain Control

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jan 22, 2020
Registry last updated
Jun 1, 2021

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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