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Dexmetomedine as an Adjuvant to Bupivacaine in Ultrasound Guided PECS Block

Primary Purpose

Post Operative Pain

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Pecs block

About this trial

This is an interventional prevention trial for Post Operative Pain

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: adult patients aged 18-60years old ASA class 1 to 3 scheduled for elective modified radical mastectomy Exclusion Criteria: patients refusal, coagulopathies concurrent anticoagulant therapy allergy to local anaesthetics infection at puncture site

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group I

Group II

GroupIII

Arm Description

received plan bupivacaine1ml/Kg

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

received plain bupivacaine 1ml/Kg plus dexmetomedine1µg/Kg

Outcomes

Primary Outcome Measures

postoperative pain

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

Secondary Outcome Measures

Total morphine consumption

Full Information

NCT ID

NCT05717114

First Posted

January 23, 2023

Last Updated

January 30, 2023

Sponsor

Menoufia University

1. Study Identification

Unique Protocol Identification Number

NCT05717114

Brief Title

Dexmetomedine as an Adjuvant to Bupivacaine in Ultrasound Guided PECS Block

Official Title

Efficacy of Different Doses of Dexmetomedine as an Adjuvant to Bupivacaine in Ultrasound Guided PECS Block in Patients Undergoing Modified Radical Mastectomy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 1, 2023 (Anticipated)

Primary Completion Date

October 1, 2023 (Anticipated)

Study Completion Date

November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

Detailed Description

All patients will be monitored by standard intraoperative monitoring that includes continuous electrocardiography (ECG), capnography, pulse oximetry, and non invasive blood pressure. Induction of general anesthesia will be done by propofol 1.5-2 mg/kg and fentanyl 3µg/kg. Tracheal intubation will be facilitated by administration of rocuronium 0.8 mg/kg. Anesthesia will be maintained with isoflurane 1MAC (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 in plane technique will be used from proximal and medial to distal and lateral in an oblique manner at dermatome level T2 and T3.The puncture site was infiltrated with 2%lidocaine and once the structures is identified with Ultrasound

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Pain

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Prospective randomized study

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Placebo Comparator

Arm Description

received plan bupivacaine1ml/Kg

Arm Title

Group II

Arm Type

Active Comparator

Arm Description

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

Arm Title

GroupIII

Arm Type

Active Comparator

Arm Description

received plain bupivacaine 1ml/Kg plus dexmetomedine1µg/Kg

Intervention Type

Procedure

Intervention Name(s)

Pecs block

Intervention Description

(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.

Primary Outcome Measure Information:

Title

postoperative pain

Description

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

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Total morphine consumption

Description

Time Frame

48 hours

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Females understanding Mastectomy

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

rabab M habeeb

Phone

+201001970973

rababhabeeb39@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

rabab M habeeb

Organizational Affiliation

Menofia University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Dexmetomedine as an Adjuvant to Bupivacaine in Ultrasound Guided PECS Block

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