Dexmetomedine as an Adjuvant to Bupivacaine in Ultrasound Guided PECS Block

Sponsor

Menoufia University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05717114

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Procedure: Pecs block	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective randomized studyProspective randomized study

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group I received plan bupivacaine1ml/Kg	Procedure: Pecs block (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.
Active Comparator: Group II received plain bupivacaine 1ml/Kg plus dexmetomedine0.5 µg/Kg	Procedure: Pecs block (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.
Active Comparator: GroupIII received plain bupivacaine 1ml/Kg plus dexmetomedine1µg/Kg	Procedure: Pecs block (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.

Arm

Intervention/Treatment

Placebo Comparator: Group I

received plan bupivacaine1ml/Kg

Procedure: Pecs block

(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.

Active Comparator: Group II

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

Procedure: Pecs block

Active Comparator: GroupIII

received plain bupivacaine 1ml/Kg plus dexmetomedine1µg/Kg

Procedure: Pecs block

Outcome Measures

Primary Outcome Measures

postoperative pain [48 hours]
Visual analog score for pain where 0 no pain and 10 most severe pain

Secondary Outcome Measures

Total morphine consumption [48 hours]
Mg

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Menoufia University

Investigators

Principal Investigator: rabab M habeeb, Menofia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

rabab Mohammad habeeb, Principal investigator, Menoufia University

ClinicalTrials.gov Identifier:

NCT05717114

Other Study ID Numbers:

1/2023,ANET2-1

First Posted:

Feb 8, 2023

Last Update Posted:

Feb 8, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Feb 8, 2023