Pain, Postoperative
Conditions
Brief summary
the study is to assess the efficacy of dexmeditomedine as an adjuvant to the local anaesthetic levobupivacaine in transversus thoracis plane block given bilaterally on the management of post-sternotomy pain.
Detailed description
the patients will fall into one of two groups using an online randomizer. this study is an assessor-blinded interventional controlled study. the first group will recieve transversus thoracis plane block bilaterally where 15 ml of 0.25% levobupivacaine will be given. and the other group shall also undergo a bilateral transversus thoracis plane block with 15 ml 0.25% levobupivacaine and 0.05 ug/kg dexmeditomedine on each side. the primary aim of the study is the 24 hour post-operative morphine consumption.
Interventions
PROCEDUREtransversus thoracis plane block
with the patient lying in the supine position. After skin disinfection, a high frequency linear ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, different drugs according to the different groups will be injected between the transversus thoracic muscle and the internal intercosatal muscle.
DRUGDexmedetomidine
the dexmeditomedine group shall undergo bilateral transversus thoracis plane block with 15 ml of 25% levobupivacaine, and 0.05 ug/kg dexmeditomedine on each side of the sternum
DRUGLevobupivacaine
A local anesthetic that will be instilled in the transversus thoracic plane in a dose of 15 ml of a 25% concentration on both sides of the sternum in both groups
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients \> 20 years old. * ASA II to III patients undergoing elective cardiac surgery via a median sternotomy
Exclusion criteria
* Patient's refusal. * Known contraindications to regional blocks, including local skin infections,and coagulopathy. * Allergies to the local anaesthetics used. * Patients undergoing complex cardiac procedures. * Patients with severe chronic obstructive pulmonary disease. * Patients unable to communicate. * Patients with chronic pain. * Patients with severe pulmonary hypertension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total post-operative morphine consumption. | 24 hours post-operative | If the patient experiences a pain of \> 4, he will be given morphine intravenously in a dose of 0.05 mg/kg IV by a blinded assessor, aiming for a pain score of ≤ 4. The total morphine dose for the post-operative 24 hours will be compared between the case and control group, to determine which technique provided more analgesia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain score | 24 hours post-operative | VAS (Visual Analogue Scale, 0-10; where 0 = no pain, and 10 = worst imaginable pain) will be assessed at rest, preoperatively, half an hour after extubation, and at 4th, 8th, 12th, 16th, 20th, and 24th hours post operatively. Moreover, VAS will also be assessed at 12th and 24 hours post-operatively while coughing. |
| Time till request of first analgesia. | 24 hours post-operative | comparison of the time till request of first analgesia difference between the two groups, shall give us a clue to the effect of demeditomedine on the duration of the pain controlling effect of the used block. |
| Intensive Care Unit (ICU) stay length. | 4 days | time till discharge from the ICU |
| Complications of the interventional block | 24 hours post-operative | * Pneumothorax. * Hemothorax. * Local anaesthetic systemic toxicity. * Intravascular injection. * Allergy to the local anaesthetic used. * Infection. * Hematoma. * Neural injury. * Damage to internal thoracic artery. |
Contacts
Primary ContactAhmed W Shamsedine, Assistant lecturer
Outcome results
None listed