Anesthesia, Arthropathy Shoulder, Pain, Acute
Conditions
Keywords
ambulatory surgery, rotator cuff repair, regional anesthesia
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREContinuous perineural infusion
infusion rate 4 ml/h, with 5 ml boluses (30-minute lockout). The PCA button disabled
PROCEDURESingle injection
infusion rate 0 ml/h, with 5 ml boluses (30-minute lockout). The PCA button will be enabled for rescue bolus administration
Sponsors
Pontificia Universidad Catolica de Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Due to the nature of the intervention, both patients and healthcare personnel involved in the intraoperative and postoperative care of the patients will be blinded to the intervention. The PCA button for administering rescue boluses will be stored inside an opaque bag, containing the pump and button, so it will not be available for initial use by the volunteers. The control group will have the infusion activated and the bolus button clamped, while the intervention group will have the infusion set to zero and the bolus button unclamped.
Intervention model description
Randomized, blinded, two-group clinical trial with a two-stage analysis (non-inferiority followed by superiority, if applicable).
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults (≥18 years, \< 75 years) scheduled for elective outpatient arthroscopic rotator cuff repair surgery. * Patients capable of managing a continuous outpatient regional analgesia system based on an interscalene block (eligibility criteria: able to understand verbal and written instructions, have home support, and live geographically close to the healthcare center). * Willing and able to provide informed, written consent to participate in the study.
Exclusion criteria
* History of chronic opioid use (\>3 months). * Severe comorbidities (e.g., renal or hepatic failure, ASA classification of 3 or higher). * Allergy to local anesthetics, dexamethasone, or the analgesic drugs used in the study. * Patients with contraindications for peripheral nerve block.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily score on the Quality of Recovery-15 (QoR-15) scale during the first 3 postoperative days. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption during the first 3 postoperative days | Daily consumption during the first 3 postoperative days. | To assess rescue opioid consumption, expressed as morphine equivalents, during the first three postoperative days. |
| Daily Numeric Rating Score (NRS) during the first 3 postoperative days | 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. |
| Rate of consultations/readmissions | During the first 3 postoperative days | To assess the rate of consultations or readmissions due to pain or other complications in both groups. |
| Rate of rescue analgesic (bolus) during the first 3 postoperative days | 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. |
Countries
Chile
Contacts
Primary ContactFernando R Altermatt, MD
Backup ContactVictor Contreras, MSN
Outcome results
None listed