NCT05717114

Brief Summary

Regional anesthesia is an essential component of anesthesia and analgesia. It has many advantages, it decreases pain post operatively, improves patient outcome and allow early recovery and ambulation Post-operative pain following breast surgery results from injured muscles and nerves, management of acute post operative pain is a consistent factor for better outcome and patient satisfaction

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

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

January 23, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

February 5, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

January 23, 2023

Last Update Submit

January 30, 2024

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • postoperative pain

    Visual analog score for pain where 0 no pain and 10 most severe pain

    48 hours

Secondary Outcomes (1)

  • Total morphine consumption

    48 hours

Study Arms (3)

Group I

PLACEBO COMPARATOR

received plan bupivacaine1ml/Kg

Procedure: Pecs block

Group II

ACTIVE COMPARATOR

received plain bupivacaine 1ml/Kg plus dexmetomedine0.5 µg/Kg

Procedure: Pecs block

GroupIII

ACTIVE COMPARATOR

received plain bupivacaine 1ml/Kg plus dexmetomedine1µg/Kg

Procedure: Pecs block

Interventions

Pecs blockPROCEDURE

(Pecs block):the block will be performed with the patients in the supine position.The infraclavicular and axillary regions will be cleaned with antiseptic solution. the inplane technique will be used from proximal and medial to distal and lateral in an oblique manner at dermatome level T2and T3.The puncture site was infiltrated with 2%lidocaine and once the structures is identified with ultrasound.

Group IGroup IIGroupIII

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales understanding Mastectomy
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • adult patients
  • aged 18-60years old
  • ASA class 1 to 3
  • scheduled for elective modified radical mastectomy

You may not qualify if:

  • patients refusal,
  • coagulopathies
  • concurrent anticoagulant therapy
  • allergy to local anaesthetics
  • infection at puncture site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia

Menoufia, Monufia Governorate, 32817, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • rabab M habeeb

    Menoufia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective randomized study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 8, 2023

Study Start

February 5, 2023

Primary Completion

December 25, 2023

Study Completion

January 1, 2024

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

EG(1)