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Serratus Plane Block vs Erector Spinae Plane Block on Postoperative Analgesia in Patients Undergoing Unilateral Breast Surgery

Primary Purpose

Breast Cancer, Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine Injection
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring serratus plane block, erector spinae plane block, postoperative analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA I-II
  • Age: 18 - 65 years
  • unilateral breast surgery

Exclusion Criteria:

  • Does not approve the study
  • Pregnant
  • Emergency
  • ASA III-IV
  • History of local anesthetic allergy
  • Infection in the block area
  • Coagulation disorder
  • Morbid obesity (body mass index> 40 kg / m²)
  • Severe organ failure
  • Previous neurological deficit
  • Psychiatric disease
  • History of chronic pain

Sites / Locations

  • SBÜ Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group S

Grup E

Arm Description

Serratus plane block with 25 ml %0.25 bupivacaine

Erector spinae plane block with 25 ml %0.25 bupivacaine

Outcomes

Primary Outcome Measures

Postoperative pain score
Visual analog scale (0-10), <4 is adequate analgesia
Postoperative tramadol consumption
Postoperative opiodi consumption with patient controlled analgesia
Rescue analgesic
If VAS score is 4 or more, paracetamol 1 gr is administered

Secondary Outcome Measures

Analgesia time
Time from block performing to first analgesia requirement

Full Information

First Posted
January 3, 2020
Last Updated
January 29, 2020
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04218149
Brief Title
Serratus Plane Block vs Erector Spinae Plane Block on Postoperative Analgesia in Patients Undergoing Unilateral Breast Surgery
Official Title
Comparison of the Effects of Serratus Plane Block and Erector Spinae Plane Block on Postoperative Analgesia in Patients Undergoing Unilateral Breast Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
September 29, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Interfacial plan blocks are becoming more widely used for postoperative analgesia because of their easier applicability and less risk of complications. In this study, we aimed to compare the effects of serratus plane block (SPB) and erector spinae plane block (ESPB) on postoperative analgesia in patients undergoing unilateral breast surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Postoperative Pain
Keywords
serratus plane block, erector spinae plane block, postoperative analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group S
Arm Type
Active Comparator
Arm Description
Serratus plane block with 25 ml %0.25 bupivacaine
Arm Title
Grup E
Arm Type
Active Comparator
Arm Description
Erector spinae plane block with 25 ml %0.25 bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection
Intervention Description
Block with bupivacaine
Primary Outcome Measure Information:
Title
Postoperative pain score
Description
Visual analog scale (0-10), <4 is adequate analgesia
Time Frame
Postoperative 24 hours
Title
Postoperative tramadol consumption
Description
Postoperative opiodi consumption with patient controlled analgesia
Time Frame
Postoperative 24 hours
Title
Rescue analgesic
Description
If VAS score is 4 or more, paracetamol 1 gr is administered
Time Frame
Postoperative 24 hours
Secondary Outcome Measure Information:
Title
Analgesia time
Description
Time from block performing to first analgesia requirement
Time Frame
Procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA I-II Age: 18 - 65 years unilateral breast surgery Exclusion Criteria: Does not approve the study Pregnant Emergency ASA III-IV History of local anesthetic allergy Infection in the block area Coagulation disorder Morbid obesity (body mass index> 40 kg / m²) Severe organ failure Previous neurological deficit Psychiatric disease History of chronic pain
Facility Information:
Facility Name
SBÜ Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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Serratus Plane Block vs Erector Spinae Plane Block on Postoperative Analgesia in Patients Undergoing Unilateral Breast Surgery

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