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NCT Number: NCT04702061

Comparison of Erector Spina Plane Block and Thoracic Epidural Block

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eskisehir Osmangazi University

Eskişehir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Erector spina plane block before general anaesthesia

Other

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.

Thoracic epidural block before general anaesthesia

Other

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.

Primary outcomes

  1. Sympathetic block level evaluation with skin conductivity

    Time frame: 45 minutes after block administration

    Skin conductivity will be measured by galvanic skin response (GSR)

  2. Sympathetic block level evaluation with skin temperature

    Time frame: 45 minutes after block administration

    Skin temperature of bilateral thorax will be measured

  3. Sympathetic block level evaluation with hot cold test

    Time frame: 45 minutes after block administration

    Hot cold test of bilateral thorax will be measured

  4. Sympathetic block level evaluation by hemodynamic data

    Time frame: 45 minutes after block administration

    Peri-operative heart rate and mean arterial pressure will be recorded

  5. Sensorial block level evaluation

    Time frame: 45 minutes after block administration

    By pin-prick test

Secondary outcomes

  1. intraoperative hemodynamic data

    Time frame: During the operation

    Heart rate and mean arterial pressure

  2. Postoperative pain scores

    Time frame: 24 hours after operation

    Pain score will be measured with visual analog scale (0-no pain; 10-worst pain) during movement and rest.

  3. Rescue analgesics consumption

    Time frame: During the operation and 24 hours after operation

    Amount of remifentanil (microgram)

  4. Rescue analgesics consumption

    Time frame: 24 hours after operation

    Amount of tramadol (milligram)

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

Comparison of Erector Spina Plane Block and Thoracic Epidural Block in Breast Surgery

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 8, 2021
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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