Red de Salud UC Christus
Santiago, 8330024, Chile
Location status: Recruiting
NCT Number: NCT06754657
The purpose of the study will be to compare the efficacy of single-injection interscalene block versus continuous interscalene block on the quality of recovery in patients undergoing outpatient arthroscopic rotator cuff repair surgery.
The participants will:
* Be randomized to receive either a single-injection interscalene block or continuous infusion via an elastomeric pump. * Be monitored via telephone by the research team to complete the QoR-15 survey, assess pain levels, the need for tramadol use, and any complications. * Have follow-up by the Acute Pain Unit during the first 3 days.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 4
Santiago, 8330024, Chile
Location status: Recruiting
After obtaining approval from the institutional CEC-CCSS and prospective registration of the study at clinicaltrials.org, the investigators will recruit patients who meet the inclusion criteria and provide written consent.
Following surgery and placement of the interscalene block with a catheter, in the recovery unit, participants will be assigned to one of two groups according to a random number table, in a 1:1 ratio using block randomization (block sizes of 4, 6, and 8) through sealed envelopes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
infusion rate 4 ml/h, with 5 ml boluses (30-minute lockout). The PCA button disabled
infusion rate 0 ml/h, with 5 ml boluses (30-minute lockout). The PCA button will be enabled for rescue bolus administration
Time frame: Preoperative score and daily score during the first 3 postoperative days.
The QoR-15 is a validated instrument in the literature that assesses the quality of recovery in patients after surgery. It is a multidimensional measurement tool that allows healthcare professionals to gain an overview of the patient's well-being during the postoperative period. The questionnaire consists of 15 items, covering 5 dimensions: Physical Comfort, Physical Independence, Emotional Support, Psychological Well-being, and Satisfaction with Recovery. The minimum score on the scale is 0 points, and the maximum score is 150 points. This range is obtained by summing the scores of the different categories evaluated in the QoR-15 scale, where a higher score indicates a better quality of postoperative recovery.
Time frame: Daily consumption during the first 3 postoperative days.
To assess rescue opioid consumption, expressed as morphine equivalents, during the first three postoperative days.
Time frame: Daily NRS during the first 3 postoperative days
The NRS (Numeric Rating Scale) is commonly used to assess pain intensity. Its minimum score is 0, indicating no pain, and its maximum score is 10, indicating the worst pain imaginable. This scale is simple and allows patients to rate their pain using a number from 0 to 10. The objective is to assess the intensity of acute postoperative pain, expressed as NRS, during the first 3 postoperative days.
Time frame: During the first 3 postoperative days
To assess the rate of consultations or readmissions due to pain or other complications in both groups.
Time frame: During the first 3 postoperative days
In the case that patients do not experience pain relief with the established management, as indicated by persistent NRS ≥ 4 after the administration of more than two rescue tramadol tablets, they will be instructed to call the contact phone number of the Ambulatory Pain Management Unit to receive guidance on how to implement a rescue bolus using the perineural catheter and the bolus option of the elastomeric pump. This event will be documented and recorded with the time of occurrence in a mobile application developed for this purpose.
Contact information is provided by the study sponsor or research team.
Fernando R Altermatt, MD
CONTACT
56955049115 ext. 9115
Victor Contreras, MSN
CONTACT
56223543414 ext. 3414
Pontificia Universidad Catolica de Chile
Other
Comparison of Continuous vs. Single-injection Interscalene Block on QoR-15 in Outpatient Rotator Cuff Surgery: A Randomized Study Assessing Non-inferiority and Superiority (CORA-Q15)
Acronym: CORA-Q15
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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