Trials / Completed
CompletedNCT04702061
Comparison of Erector Spina Plane Block and Thoracic Epidural Block
Comparison of Erector Spina Plane Block and Thoracic Epidural Block in Breast Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Inonu University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Erector 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. |
| OTHER | Thoracic 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. |
Timeline
- Start date
- 2021-01-11
- Primary completion
- 2021-03-31
- Completion
- 2021-03-31
- First posted
- 2021-01-08
- Last updated
- 2021-04-20
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT04702061. Inclusion in this directory is not an endorsement.