Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04916418 |
Other study ID # |
T39/2021 |
Secondary ID |
2020-004178-23 |
Status |
Active, not recruiting |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
October 15, 2021 |
Est. completion date |
December 1, 2024 |
Study information
Verified date |
April 2024 |
Source |
Turku University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study aims to investigate the effect of transversus thoracis muscle plane block (TTP),
using repeated boluses of ropivacaine via catheter, on postoperative pain and oxycodone
consumption after elective cardiac surgery with sternotomy.
Description:
This randomized, double-blinded, controlled study aims to investigate the effect of
transversus thoracis muscle plane block (TTP), using repeated boluses of ropivacaine via
catheter, on postoperative pain and oxycodone consumption after elective cardiac surgery with
sternotomy. Altogether 120 eligible patients, sixty per group, will be recruited into the
study, after informed consent at the discretion of the principal investigator.
All patients will receive 20 mg of temazepam orally as a premedication one hour before
anaesthesia. General anaesthesia will be induced with propofol and sufentanil 0.5 μg/kg.
Anaesthesia will be maintained with inhalational anaesthetic sevoflurane and sufentanil 0.005
μg ˖ kg-1 ˖ min-1 intravenous infusion. Opioids other than sufentanil will not be used before
or during anaesthesia.
After inclusion for the study, the patient will be randomized to one of the two study groups
(G1 and G2). At the end of the surgery, when sternal wound is secured, bilateral TTP block
with ultrasound guidance is performed to both groups. G1 group will receive an initial dose
of 20ml placebo (NaCl 0,9%) per catheter bilaterally (total volume 40ml), followed by 20ml
doses of placebo per catheter every 8 hours until 72 hours from the first dose and G2 group
will receive initial dose of 20ml ropivacain 0,5% per catheter bilaterally (total volume
40ml) followed by doses of ropivacain 0,2% 20ml per catheter every 8 hours until 72 hours
from the first dose has passed.
All the patients will receive a patient-controlled analgesia (PCA) pump for added pain
relief. After the setting of two TTP catheters, PCA pump will be attached to intravenous line
and activated. Oxycodone PCA is used with 3 mg dose and lockout interval of 10 minutes. No
continuous background infusion will be used during the postoperative period. When the patient
is weaned from ventilator in the ICU, they are encouraged to use PCA for postoperative pain
whenever necessary. If the patient is assessed to suffer from pain and is unable to use the
PCA device, they will be assisted by the ICU nurse. The total duration of PCA oxycodone
treatment will be 3 days (72 hours). No oral opioids or ketamine will be used. Each patients
will be given 1000mg paracetamol intravenous infusion at the time of awakening and thereafter
every 8 hours during TTP and PCA treatments.
During recovery, the patient assess the amount of their pain using numerical rating scale
(NRS, range 0-10). If the patient is sedated and/or under mechanical ventilation, behavioral
pain scale (BPS) will be used to estimate the amount of pain in the ICU.