NCT04908878

Brief Summary

The aim of this study is to evaluate the analgesic efficacy of combined ultrasound (US)-guided pectoral nerve (PECS) block II and transversus thoracic plane (TTP) block versus US-guided serratus anterior plane (SAP) block in female patients undergoing modified radical mastectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

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

May 27, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2022

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

May 27, 2021

Last Update Submit

November 28, 2022

Conditions

Ultrasound-GuidedTranseversus Thoracic Plane BlocksPectoral Nerve (PECS) BlockSerratus Anterior Plane BlockModified Radical Mastectomy

Outcome Measures

Primary Outcomes (1)

  • The total amount rescue analgesic consumption (morphine) in the first 24 hours postoperatively.

    Rescue analgesia in the form of morphine (3mg IV) will be given if the VAS is ≥ 40, repeated with lock out interval of 5 min guided with the occurrence of complications till the VAS is decreased to less than 40.

    First 24 hours postoperatively.

Secondary Outcomes (3)

  • The degree of postoperative pain

    First 24 hours postoperatively.

  • Time to first rescue analgesia request.

    First 24 hours postoperatively.

  • Intraoperative fentanyl consumption.

    Intraoperative

Study Arms (2)

Group I (pectoral nerve (PECS) block -transversus thoracic plane (TTP) block group)

EXPERIMENTAL

Patients will receive unilateral US-guided PECS II block and TTP block on the side of the operation after induction of general anesthesia.

Procedure: Pectoral nerve (PECS) block -transversus thoracic plane (TTP) block

Group II (serratus anterior plane (SAP) block group)

EXPERIMENTAL

Patients will receive US-guided SAP block after induction of general anesthesia.

Procedure: Serratus anterior plane (SAP) block

Interventions

Pectoral nerve (PECS) block -transversus thoracic plane (TTP) blockPROCEDURE

Patients will receive unilateral US-guided PECS II block and TTP block on the side of the operation after induction of general anesthesia.

Group I (pectoral nerve (PECS) block -transversus thoracic plane (TTP) block group)
Serratus anterior plane (SAP) blockPROCEDURE

Patients will receive US-guided SAP block after induction of general anesthesia.

Group II (serratus anterior plane (SAP) block group)

Eligibility Criteria

Age21 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female patients
  • Aged 21-60 years
  • ASA physical status I, II
  • Scheduled for unilateral modified radical mastectomy

You may not qualify if:

  • Patient refusal.
  • Known hypersensitivity to local anesthetics.
  • Body mass index \> 35 kg /m2.
  • Uncooperative or psychiatric patients.
  • Infection at the injection site.
  • Coagulation disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Tanta University

Tanta, Elgharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Bites and Stings

Interventions

thiamine triphosphorateDental Occlusion

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Anesthesiology, Surgical ICU and Pain medicine

Study Record Dates

First Submitted

May 27, 2021

First Posted

June 1, 2021

Study Start

June 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 2, 2022

Last Updated

November 29, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

The data will be available upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
one year
Access Criteria
The data will be available upon reasonable request.

Locations

EG(1)