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Completed

NCT Number: NCT04706247

Thoracic Combined Spinal Epidural Anesthesia for Breast Surgery

The aim of the study is to investigate the efficacy of the thoracic combined spinal epidural anesthesia in breast surgery.

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Key information

Conditions

Pain Breast Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 month–70 month

Sex eligibility

Female

Study type

Observational

Primary location

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

About this study

Previous studies of the regional anesthetic techniques such as erector spinae plane block and pectoralis nerve blocks (PECs blocks) additional to general anesthesia have described their use for postoperative analgesia in breast surgery. It has been also reported that these blocks can be used to provide surgical anesthesia in breast surgery . Segmental thoracic epidural anesthesia can be used as an alternative anesthetic technique in patients with severe chronic obstructive pulmonary disease and asthma undergoing breast surgery. It has been also reported that thoracic spinal anesthesia was effective and successful in patients undergoing laparoscopic surgery. In this study, efficacy of high thoracic spinal epidural anesthesia in patients undergoing breast surgery will be evaluated.

Who can participate

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

Inclusion criteria

  • Patients who will be to undergo elective surgery for breast surgery
  • American Society of Anesthesiologists (ASA) physical status classification groups I or II

Exclusion criteria

  • body mass index>35 kg/m2,
  • presence of any condition complicating and contraindicating spinal epidural anesthesia.

Treatment and study plan

thoracic combined spinal epidural anesthesia

Other

A combined spinal-epidural anesthesia set will be used for the block. Using the loss of resistance to saline technique, an 18 G Tuohy needle will be advanced to the T2-3 vertebral interspace with the mid-line approach. After confirming the epidural space, a 26 G pencil point spinal needle will be inserted slowly through the Tuohy needle to puncture the dura. After free flow of cerebrospinal fluid will be observed, local anesthetic wil be injected into the subarachnoid space over 15 secs. Then, an epidural catheter will be inserted into the epidural space.

Primary outcomes

  1. Block success

    Time frame: through study completion, an average of 3 months

    the number of patients whose surgery was completed without general anesthesia

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

Segmental High Thoracic Combined Spinal Epidural Anesthesia for Breast Surgery

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 12, 2021
Registry last updated
May 18, 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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