24
Participants
Start Date
September 23, 2024
Primary Completion Date
August 31, 2025
Study Completion Date
December 1, 2025
ESP block with catheter using ropivacaine (bolus followed by continuous infusion)
A total of ropivacaine 75mg will be injected into the plane via the needle, followed by placement of a catheter 3-5 cm into the plane. A continuous infusion of ropivacaine 0.2% will be started at 8 mL/h and may be titrated up to a maximum of 10mL/h. Bolus doses of 5 mL using ropivacaine 0.2% will be permitted for breakthrough pain (pain score ≥ 7/10) and may be administered no more frequently than every 6 hours. Patients will be assessed for LAST twice daily by asking about tinnitus, perioral numbness, or metallic taste. Any patient who responds positively to these symptoms will have infusion stopped for 2 h and then restarted at a rate 2 mL/h lower. If the symptoms occur again, the catheter infusion will be stopped and the catheter removed. After the 72-hour study period the ESP catheter may remain in place if the patient has ongoing analgesia needs or if analgesia is controlled with oral medication the catheter may be removed at request of the treating team.
Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h
A bolus of 1 mg/kg based on ideal body weight will be given over 10 minutes with a physician present and infusions will be started at 1 mg/kg/h based on IBW. Infusions will run continuously for the first 72 h and can be continued beyond that at the discretion of the treating team if pain persists. Patients will be assessed for LAST twice daily. Any patient with suspected LAST will have lidocaine infusion stopped and a lidocaine plasma level will be sent. If symptoms resolve, the lidocaine infusion can be restarted at a rate 25% lower. If pain is refractory to the lidocaine infusion and multimodal adjuncts, the infusion may be increased to a maximum of 1.5 mg/kg/h (during first 24 h only). The actual duration of the infusion as well as total lidocaine dose given in mg will be recorded. Stopping criteria for lidocaine will include the occurrence of new EKG changes for which an alternative explanation is not more likely as well as LAST symptoms.
Thomas Jefferson University Hospital, Philadelphia
Thomas Jefferson University
OTHER