NCT05661279

Brief Summary

evaluate and compare the impact of ultrasound guided rhomboid intercostal block versus serratus anterior plane block for analgesia after thoracodorsal artery perforator flap following partial mastectomy

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 22, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

December 30, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

December 1, 2022

Last Update Submit

September 2, 2023

Conditions

Postoperative Pain

Keywords

rhomboid intercostal block -serratus anterior plane block - thoracodorsal artery perforator flap

Outcome Measures

Primary Outcomes (1)

  • tramadol consumption

    The amount of tramadol consumption

    at 24 hours postoperative

Secondary Outcomes (4)

  • Time of performance of block

    time from positioning of ultrasound porbe till the end of block procedure.

  • Time to first dose of rescue analgesia

    during the first 24 hours postoperatively

  • Anticipated side effect

    at 24 hous post operative

  • Post operative patient's satisfaction

    at 24 hours post operative

Study Arms (3)

Group C:

ACTIVE COMPARATOR

control group who will be given general anesthesia only

Procedure: general anesthesia

Group R:

ACTIVE COMPARATOR

Rhomboid intercostal block then general anesthesia

Procedure: general anesthesiaProcedure: general anesthesia plus Rhomboid intercostal block

group S

ACTIVE COMPARATOR

Serratus anterior plane block then general anesthesia

Procedure: general anesthesiaProcedure: Serratus anterior plane block

Interventions

general anesthesiaPROCEDURE

general anesthesia

Group C:Group R:group S
general anesthesia plus Rhomboid intercostal blockPROCEDURE

the patients will be positioned in lateral decubitus with moving the scapula laterally by abducting the ipsilateral arm across the chest. under complete aseptic situations A high-frequency (6-12 MHz) linear US probe will be put medial to the medial border of the scapula in an oblique sagittal plane with the orientation marker directed cranially.at the T6-7 level, the tissue plain between the rhomboid major and intercostal muscles is identified, and a single injection of 25mL of bupivacaine (0.25%) will be administered via 18-gauge Tuohy advanced in plane from a superomedial to an inferolateral direction, followed by general anesthesia

Group R:
Serratus anterior plane blockPROCEDURE

The patient will be positioned supine with his arm abducts at 90°. the US high frequency (6-12 MHz) linear probe of sonosite M turbo ultrasonography (FUJIFIM sonosite, Inc., Bothell, WA, USA) will be put in sagittal plane at the midaxillary line. identification of the fascial plane between the serratus anterior muscle and external intercostal muscles will be performed between the fourth and fifth ribs in the midaxillary area . At this point the18-gauge Tuohy needle will be advanced in plane with injection of 25mL of 0.25 %, bupivacaine. followed by general anesthesia

group S

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients aged between 21 to 60 years
  • Undergoing pedicled thoracodorsal artery perforator flap following breast conserving surgery -General anesthesia
  • Informed consents
  • ASA I \& II
  • Body mass index 25-30 kg/m2.

You may not qualify if:

  • patients on anti-platelet, anticoagulant or B blocker drugs
  • Patients with acute decompensated heart failure, hypertension, heart block, coronary disease, Asthma, bleeding disorders, compromised renal or hepatic function
  • history of allergy to local anesthesia or opioid analgesia,
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heba M Fathi

Zagazig, 44519, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Heba M Fathi

    faculty of human medicine ,zagazig university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heba M Fathi, M.D

CONTACT

01000143938heba_elgendi@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof/Dr

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 22, 2022

Study Start

December 30, 2022

Primary Completion

October 2, 2023

Study Completion

October 30, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)