COmparison Erect SPINE in Cardiac Surgery (COESPINE)

• Status: Not yet recruiting
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Open cardiac surgeries are characterized by the increased use of opioids and longer extubation times, being post-sternotomy pain one of the causes of greater patient discomfort, plexus blockages have been used more frequently given the good results of anatomical studies and case series that are just beginning to be published. however, there is not enough data to convince the scientific community of its advantages, continuing to carry out its performance due to lack of evidence. Dexamethasone also shows an excellent result blocking the inflammatory chain and it was evidenced that it prolongs the time of blockages when used perineurally in the plexus blockages. This study wants to show the improvement of pain in patients who undergo this type of surgery and also show the advantages of a longer blockage, which can reduce the congestions of analgesic and opioids, as well as decrease the time of hospitalization This is a double-blinded, randomized, clinical trial designed to determine the efficacy of spine erector whit dexamethasone gives more duration of the blockage and less pain after cardiac surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto do Coracao
• Treatments: Anesthetics; Anesthetics, Local; BB 1101; Dexamethasone; Dexamethasone acetate; Ropivacaine

Criteria

Inclusion Criteria:

• Coronary artery bypass graft with cardiopulmonary bypass

• Left ventricular ejection fraction ≥ 45%

Exclusion Criteria:

• Reoperation

• Low cardiac output syndrome

• Preoperative coagulopathy

• Presence of ventricular assist device other than intraaortic ballon pump

• Emergency procedures

• Bacterial or fungal infection in the preceding 30 days

• Active neoplasia

• Allergy or intolerance to steroids

• Allergy to ropivacaine

• Patient refusal

• Participation in other study