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The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery

Primary Purpose

Postoperative Pain, Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Erector Spinae Plane Block

Intravenous Morphine patient controlled analgesia device

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring erector spinae plane block, breast surgery, postoperative pain

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

25-70 years of age
ASA I-II
Undergoing elective breast cancer surgery

Exclusion Criteria:

obesity (body mass index >35 kg/m2)
infection of the skin at the site of needle puncture area
patients with known allergies to any of the study drugs
coagulopathy
recent use of analgesic drugs.

Sites / Locations

Kocaeli University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Block Group

Control Group

Arm Description

Erector Spinae Plane Block administered group

Control group

Outcomes

Primary Outcome Measures

Morphine consumption

Secondary Outcome Measures

Full Information

NCT ID

NCT03415646

First Posted

January 10, 2018

Last Updated

March 7, 2018

Sponsor

Kirsehir Ahi Evran University

1. Study Identification

Unique Protocol Identification Number

NCT03415646

Brief Title

The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery

Official Title

The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

February 3, 2018 (Actual)

Primary Completion Date

March 5, 2018 (Actual)

Study Completion Date

March 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Postoperative analgesia in breast surgery is a difficult and overworked issue due to extensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined regional anesthesia technique for thoracic analgesia.Main purpose of this study was to evaluate the analgesic effect of ultrasound guided double injection ESB in breast surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Breast Cancer

Keywords

erector spinae plane block, breast surgery, postoperative pain

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Block Group

Arm Type

Active Comparator

Arm Description

Erector Spinae Plane Block administered group

Arm Title

Control Group

Arm Type

Sham Comparator

Arm Description

Control group

Intervention Type

Other

Intervention Name(s)

Erector Spinae Plane Block

Intervention Description

erector spinae plane block with double level injection will be administered before the surgery

Intervention Type

Device

Intervention Name(s)

Intravenous Morphine patient controlled analgesia device

Intervention Description

24 hour morphine consumption will be recorded

Primary Outcome Measure Information:

Title

Morphine consumption

Time Frame

24 hour postoperatively

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 25-70 years of age ASA I-II Undergoing elective breast cancer surgery Exclusion Criteria: obesity (body mass index >35 kg/m2) infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy recent use of analgesic drugs.

Facility Information:

Facility Name

Kocaeli University Hospital

City

İzmit

State/Province

Kocaeli

ZIP/Postal Code

41340

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery

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