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NCT04706247 Clinical Trial

Thoracic Combined Spinal Epidural Anesthesia for Breast Surgery

Pain Clinical Trial

Official title:
Segmental High Thoracic Combined Spinal Epidural Anesthesia for Breast Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04706247
Other study ID # lutfi1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 4, 2021
Est. completion date May 17, 2021

Study information
Verified date January 2021
Source Antalya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date May 17, 2021
Est. primary completion date April 13, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Months to 70 Months
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• thoracic combined spinal epidural anesthesia
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.

Locations
Country Name City State
Turkey Antalya Training and Research Hospital Antalya

Sponsors (1)
Lead Sponsor Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Block success the number of patients whose surgery was completed without general anesthesia through study completion, an average of 3 months
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