NCT06381765

Brief Summary

ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study. Patients will divide into 2 groups. Deep serratus plane block will perform with 0,25 %bupivacaine 20 ml at the midaxillary 5. rib, bilaterally for Group I. At Group II, deep serratus plane block ( 0,25 %bupivacaine 20 ml) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally . General anesthesia with sevoflurane and remifentanil will perform to the all patients. Postoperative pain scores, morphine consumption and complications will record till the 24.th hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable postoperative-pain

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

May 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2024

Completed
Last Updated

September 19, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

April 19, 2024

Last Update Submit

September 9, 2024

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

  • postoperative morphine consumption

    Patient controlled analgesia with morphine will perform to the all patients and morphine consumption will calculate and record till the end of 24.th hours.

    All the patients will follow till the postoperative 24.th hours and totally morphine consumption will record postoperative 24.th hours.

  • postoperative visual analog scale scores

    All the patients will evaluate with visual analog scale scores (VAS) at the first postoperative 24.th hours period. VAS scores will define between 0-10 scores. 0 score means lowest pain score and 10 means the worst pain score.

    VAS scores will record at the first postoperative 24.th hours

Study Arms (2)

Serratus plane block

ACTIVE COMPARATOR

Deep serratus plane block will perform with 20 ml 0,25 %bupivacaine at the midaxillary 5. rib, bilaterally

Procedure: ultrasound guided Serratus plane bock

Serratus plane block+pectointercostal plane block

ACTIVE COMPARATOR

deep serratus plane block (20 ml 0,25 %bupivacaine) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally .

Procedure: ultrasound guided Serratus plane bock and pectointercostal block

Interventions

ultrasound guided Serratus plane bock and pectointercostal blockPROCEDURE

ultrasound guided serratus plane block (20 ml 0,25 %bupivacaine) will perform at the midaxillary 5.th rib and pectointercostal plane block (0,25% bupivacaine 15 ml) will perform at 4-5.th intercostal space. Both 2 blocks will perform bilaterally

Serratus plane block+pectointercostal plane block
ultrasound guided Serratus plane bockPROCEDURE

ultrasound guided serratus plane block (20 ml 0,25 %bupivacaine) will perform at the midaxillary 5.th rib to the all patients

Serratus plane block

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details18-65 aged females.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II patients
  • Female
  • who will undergoing Breast reduction surgery

You may not qualify if:

  • ASA III and over patients
  • who reject to join the study
  • male gender

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çukurova University Faculty of Medicine

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Ebru Biricik

    çukurova university faculty of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 19, 2024

First Posted

April 24, 2024

Study Start

May 10, 2024

Primary Completion

September 2, 2024

Study Completion

September 2, 2024

Last Updated

September 19, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)