NCT04005534|Completed
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Sponsor study identifier
interventional
70
1 country
1
Study Start
December 14, 2022
Actual (reported)Primary Completion
March 1, 2024
Actual (reported)Study Completion
March 10, 2024
Actual (reported)Intense e recurrent nociceptive stimulation, which occurs in the postoperatively, can trigger sensitization of the peripheral and central nociceptive pathway, leading to chronic pain. Patients with rotator cuff injury often present to surgery due to referred moderate to intense long-term pain. During the immediate postoperative period, pain is rare due to the routine administration of a brachial plexus blockade as an adjuvant to improve the quality of postoperative analgesia. However, after the second postoperative day, the effect of the blockade ceases, and the pain becomes high and hard to treat, leading the patient to request administration of more frequent and more potent analgesics. The aim of this project is to assess the postoperative analgesic benefits of a brachial plexus blockcade 2 days before arthroscopic surgical correction of rotator cuff injury by reducing the sensitization of the nociceptive pathway.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 10, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 24, 2019
Actual (reported)July 2, 2019
Actual (reported)December 14, 2022
Actual (reported)March 1, 2024
Actual (reported)March 10, 2024
Actual (reported)Pain score on third postoperative day
Pain assessment through verbal numerical scale of pain (from 0 to 10).
Three days
Pain scores before surgery.
Just before surgery
Pain cores on three postoperative days.
Three days.
Opioid consumption
Two days before surgery
Opioid consumption
Three days
Patients from this group will undergo only ultrasound examination of the brachial plexus, two days before the surgery. On the day of surgery they will undergo ultrasound-guided brachial plexus blockade (interscale access; 15 ml 1% ropivacaine and sedation (midazolam 3 mg, fentanyl 50 µg and 15 mg ketamine.
Patients from this group will undergo ultrasound-guided brachial plexus blockade, two days before the surgery. On the day of surgery they will undergo ultrasound-guided brachial plexus blockade (interscale access; 15 ml 1% ropivacaine and sedation (midazolam 3 mg, fentanyl 50 µg and 15 mg ketamine.
Ultrasound examination of the brachial plexus 2 days before the surgery. Ultrasound guided brachial plexus blockade and sedation on the day of surgery.
Ultrasound guided brachial plexus blockade 2 days before the surgery. Ultrasound guided brachial plexus blockade and sedation on the day of surgery.
Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 01246-903, Brazil
Joaquim Vieira, Professor
University of Sao Paulo School of Medicine
70 participants (actual enrollment reported by the registry).
First Submitted
June 24, 2019
First Posted
July 2, 2019
Bilateral Cervical Plexus Block for Postoperative Pain After Thyroidectomy
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Study Start
December 14, 2022
Actual (reported)Primary Completion
March 1, 2024
Actual (reported)Study Completion
March 10, 2024
Actual (reported)Last Updated
April 16, 2024
Record last verified: 2024-04
The data will only be available for researchers after the end of the data collection and analysis on request.
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Source: ClinicalTrials.gov.
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