Erector Spinae Block in Segmental Mastectomy.

Not Applicable

• Conditions: Breast Cancer
• Interventions: Procedure: erector spinae block; Procedure: Control group

• Registration Number: NCT03509090
• Lead Sponsor: Maltepe University

Brief Summary

Erector spinae plane block (ESPB) is a recently described block. Although there is still no consensus of its mechanism, the published case series seems to promise a new regional anesthesia technique for both chronic and acute pain. In this clinical trial, the postoperative analgesic effect of ESPB will be studied in patients underwent unilateral breast cancer surgery.

Detailed Description

In this study 30 patients will be enrolled to study between March 2018-August 2018. All patient will be randomly selected who will be operated for breast cancer surgery between determined dates. Age, weight, ASA score, body mass index , additional dissease ststus will be recorded. The patients will be divided in two groups. One group will have ESPB at the end of the operation and the second group will be treated with multimodal analgesia techniques and both groups will receive patient controlled analgesia. Both groups will receive identical anaethesia protocols. Perioperative analgesia protocols will provide acetaminophen 1 gr and the same dose will be repeated in every 6 hours regardless of the pain scores. In postoperative period the pain scores of the patients will be recorded according to the numeric rating scale (NRS) in every three hours. If pain score raises over 4/10 on NRS the patient will receive tramadol 100mg as rescue analgesia. In case of persisting pain first, meperidine 50 mg will be apllied and other multimodal analgesic drugs will be added to protocol. At the end of the study 24 hours total opioid usage of patients, pain scores and side effects will statistically be analyzed.

Study Timeline

• Study Start: 2018-04-03
• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2018-04-16
• Study First Posted: 2018-04-26
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-11
• Primary Completion: 2019-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Being volunteer
2. Over 18 years old
3. Unilateral segmental mastectomy patients

Exclusion Criteria

1. Emergency operations
2. Younger than 18 years old,
3. Non Volunteers
4. ASA 3 and 4 patients
5. Non-cooperative patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP block group	erector spinae block	Unilateral ESP block will be applied as postoperative regional analgesia technique in addition to the multimodal therapy. Then she is positioned in a right lateral position to perform ESP blocks. The skin will be disinfected and ESP block at one side will be performed in the lateral decubitus position and at T4 transverse process level by using 10-MHz linear ultrasound probe (Logic Ebook XP General Electrics, USA). The probe will be located 3 cm lateral to T4 spinous process in longitudinal parasagittal orientation. An 8 cm 21 gauge needle (BRAUN Stimuplex A®, Germany) will be inserted by using out of the plane technique. The ESP blocks proceed with 15 ml of 0,25% bupivacaine, 7,5 ml 1 % lidocaine, ,7,5 ml 0,9 % NaCl as total 30 ml . The injections will be applied after the confirmation of location by hidrodisection developed anterior to erector spinae muscle with 1-2 ml of local anesthetic solution.
Control group	Control group	In this group, patients will receive only multimodal analgesic treatment including patient-controlled analgesia prepared with tramadol. Patient-controlled analgesia (PCA) with tramadol at 3mg/cc concentration is programmed with no basal infusion, demand dose 10 mg and 20-minute lock-out interval. Also, patients received 1 gr paracetamol in every 6 hours.

Primary Outcome Measures

Name	Time	Method
postoperative anaglesic effect of ESPB in unilateral segmental mastectomy patients	24 hours postoperatively	Post operative pain scores will be recorded with NRS and opioid usage will be recorded

Trial Locations

Locations (1)

Maltepe University Medical Faculty; 🇹🇷 Istanbul, Turkey