Breast Neoplasms, Pain, Postoperative
Conditions
Brief summary
The aim of this randomised controlled and double-blind study, is to compare the effects of erector spinae plane (ESP) and thoracic epidural (TEA) blocks on peri-operative hemodynamics and analgesia in patients undergoing unilateral mastectomies due to malignancy.
Detailed description
Patients will be randomised into two groups as Group E (those who received general anesthesia after the erector spina plan block) and Group T (those who received general anesthesia after thoracic epidural block). After the block skin conductivity (galvanic skin response - GSR), body temperature changes, sympathetic and sensory block levels, peri-operative hemodynamic data, postoperative pain scores and analgesic consumption will be recorded.
Interventions
OTHERErector spina plane block before general anaesthesia
After skin infiltration with 2 ml of 2% lidocaine, an 18 G tuohy needle will be directed between the erector spina muscle and the transverse process of the T4 vertebra using the in-plane technique. The location of the needle will be confirmed by hydrodissection with saline after touching the transverse process. After the plan open, 5 ml of 2% lidocaine, 10 ml of 0.5% bupivacaine and 10 ml of saline, including hydrodissection, will be given in a total amount of 25 ml. Then a 20-G epidural catheter will be inserted 3-4 cm and fixed.
OTHERThoracic epidural block before general anaesthesia
After skin infiltration with 2 ml of 2% lidocaine, an 18 G tuohy needle will be entered through the T4-5 interspinous space (median or paramedian approach). After reaching the thoracic epidural area by loss of resistance method, the epidural catheter will be advanced and fixed to remain 3-4 cm in the epidural area. Following the test dose (2 ml of 2% lidocaine), 3 ml of 2% lidocaine, 5 ml of 0.5% bupivacaine and 5 ml of saline will be administered intermittently in a total volume of 15 ml.
Sponsors
Inonu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* ASA(American Society of Anesthesiologist) physical classification I-III * Patients undergoing unilateral mastectomies due to malignancy
Exclusion criteria
* Active infection at the intervention site * History of coagulopathy or anticoagulant use (less time has passed before peripheral and central blocks) * Major cardiac, pulmonary, renal and neurological diseases * Autonomic neuropathy or use of drugs that affect autonomic function * Patients with type 1 diabetes or insulin dependent type 2 diabetes over 10 years * Allergic to local anesthetics; * Patients who are uncooperative or have psychiatric problems * Morbidly obese (body mass index \> 35 kg/m2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensorial block level evaluation | 45 minutes after block administration | By pin-prick test |
| Sympathetic block level evaluation with skin temperature | 45 minutes after block administration | Skin temperature of bilateral thorax will be measured |
| Sympathetic block level evaluation with hot cold test | 45 minutes after block administration | Hot cold test of bilateral thorax will be measured |
| Sympathetic block level evaluation by hemodynamic data | 45 minutes after block administration | Peri-operative heart rate and mean arterial pressure will be recorded |
| Sympathetic block level evaluation with skin conductivity | 45 minutes after block administration | Skin conductivity will be measured by galvanic skin response (GSR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain scores | 24 hours after operation | Pain score will be measured with visual analog scale (0-no pain; 10-worst pain) during movement and rest. |
| Rescue analgesics consumption | During the operation and 24 hours after operation | Amount of remifentanil (microgram) |
| intraoperative hemodynamic data | During the operation | Heart rate and mean arterial pressure |
Countries
Turkey (Türkiye)
Outcome results
None listed