US-Guided Preemptive Brachial Plexus Blockade May Reduce Post-operative Pain: a Randomized Study

NCT04005534 | Completed

• 1 other identifier: CAAE 09012419.3.0000.5501
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Rotator Cuff Injuries

Keywords

Postoperative pain; Rotator cuff injuries; Preemptive analgesia

Outcome Measures

Primary Outcomes (1)

• Pain score on third postoperative day

  Pain assessment through verbal numerical scale of pain (from 0 to 10).

  Three days

Secondary Outcomes (4)

• 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

Study Arms (2)

Standard group

PLACEBO COMPARATOR

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.

Drug: Standard group

Preemptive group

EXPERIMENTAL

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.

Drug: Preemptive group

Interventions

Standard group DRUG

Ultrasound examination of the brachial plexus 2 days before the surgery. Ultrasound guided brachial plexus blockade and sedation on the day of surgery.

Also known as: Ultrasound examination

Standard group

Preemptive group DRUG

Ultrasound guided brachial plexus blockade 2 days before the surgery. Ultrasound guided brachial plexus blockade and sedation on the day of surgery.

Also known as: Ultrasound guided blockade

Preemptive group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index \< 35 kg/m²
• shoulder pain lasting \> 3 months
• pain score \> 3 (visual analog scale and verbal response 0 to 10) on the day of pre anesthetic evaluation
• American Society of Anesthesiologists score I or II
• mentally and legally capable to understand and consent to study participation.

You may not qualify if:

• Allergy to any medication of the trial
• refusal to participate, contraindication to any medication or technique described in the protocol of the trial
• complications from, or failure of brachial plexus blockade.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 01246-903, Brazil

Location

MeSH Terms

Conditions

Pain, Postoperative; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Joaquim Vieira, Professor

  University of Sao Paulo School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each step of the study will be performed by anesthesiologist who will not participate in any other step. All of them, and the patient will be blinded to groups.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: This is a prospective, double-blind and randomized clinical trial.

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: July 2, 2019
• Study Start: December 14, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 10, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)