NCT05911373

Brief Summary

Mastectomy is a technique often used in breast cancer surgery. Patients experience moderate to severe pain postoperatively after this procedure. Various plane blocks, NSAIDs, and opioid analgesics can be administered to these patients as components of multimodal analgesia. In the the study, the investigators aimed to evaluate the analgesic effects of the serratus plane block, the parasternal block added to the serratus plane block, and the dermatomal differences.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

June 21, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

May 30, 2023

Last Update Submit

March 29, 2024

Conditions

AnalgesiaCancer, Breast

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

    First 24 hours total fentanyl consumption with patient controlled analgesia

    first 24 hours

Secondary Outcomes (2)

  • Visual analog pain score

    First 24 hours

  • Sensory Assessment

    24 hours

Study Arms (2)

group serratus

PLACEBO COMPARATOR

preoperative superficial serratus block with local anaesthetics and parasternal block with saline

Other: group serratus plan block

group serratus and parasternal

ACTIVE COMPARATOR

preoperative superficial serratus block and parasternal block with local anaesthetics

Other: group serratus and parasternal plan block

Interventions

group serratus plan blockOTHER

preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml saline

group serratus
group serratus and parasternal plan blockOTHER

preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml %0.25 Bupivacaine

group serratus and parasternal

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologist's physiologic state I-III patients
  • To undergo Mastectomy Surgery
  • Being between the ages of 18-65 years

You may not qualify if:

  • Having a known heart, kidney, liver or hematological disease
  • Having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain
  • Routine analgesic use and history of analgesic use in the last 24 hours
  • Not willing to participate in the study
  • Uncooperative patients who have coagulopathy or use anticoagulant drugs
  • To be allergic to one of the drugs to be used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ali Ahiskalioglu

Erzurum, 25100, Turkey (Türkiye)

Location

Related Publications (2)

  • Hu NQ, He QQ, Qian L, Zhu JH. Efficacy of Ultrasound-Guided Serratus Anterior Plane Block for Postoperative Analgesia in Patients Undergoing Breast Surgery: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Pain Res Manag. 2021 Oct 25;2021:7849623. doi: 10.1155/2021/7849623. eCollection 2021.

    PMID: 34733377BACKGROUND

  • Piraccini E, Biondi G, Corso RM, Maitan S. The use of rhomboid intercostal block, parasternal block and erector spinae plane block for breast surgery. J Clin Anesth. 2020 Feb;59:10. doi: 10.1016/j.jclinane.2019.06.004. Epub 2019 Jun 6. No abstract available.

    PMID: 31176954BACKGROUND

MeSH Terms

Conditions

AgnosiaBreast Neoplasms

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hüsnü Kürşad

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 22, 2023

Study Start

June 21, 2023

Primary Completion

January 1, 2024

Study Completion

January 15, 2024

Last Updated

April 1, 2024

Record last verified: 2024-03

Locations

TU(1)