Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block

NCT03063073 | Completed Phase 3 DMC

• 1 other identifier: 224
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The Pecs block (pectoral nerves block) is an easy and reliable superficial block inspired by the infraclavicular block approach and the intercostal abdominis plane blocks . Many additives were used in combination with local anesthetics in Pecs block to prolong the postoperative analgesia (fentanyl, dexmedetomidine).

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• I.V patient controlled analgesia (PCA) morphine consumption

  the total dose of I.V patient controlled analgesia (PCA) morphine consumption in the first 48 hours postoperative

  48 hours postoperative

Secondary Outcomes (1)

• pain relief

  48 hour

Other Outcomes (1)

• stress response

  24 hour

Study Arms (2)

Group I (Bupivacaine group)

PLACEBO COMPARATOR

ultrasound guided modified Pec's block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles and 20 ml between the Pectoralis minor muscle and the serratus muscle

Drug: Bupivacaine Injection [Marcaine]

Dexmedetomidine Injection [Precedex]

ACTIVE COMPARATOR

ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine Injection \[Precedex\] (1 µg/kg) divided into 20 ml injected between the pectoralis muscles and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.

Drug: Dexmedetomidine Injection [Precedex]; Drug: Bupivacaine Injection [Marcaine]

Interventions

Dexmedetomidine Injection [Precedex] DRUG

ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine (markyrene R sigma -Tec, Egypt) plus (1 µg/kg) Dexmedetomidine Injection \[Precedex\]

Also known as: [Precedex]

Dexmedetomidine Injection [Precedex]

Bupivacaine Injection [Marcaine] DRUG

ultrasound guided modified Pec's block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles and 20 ml between the Pectoralis minor muscle and the serratus muscl

Dexmedetomidine Injection [Precedex]; Group I (Bupivacaine group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I - II patients
• weight 50- 100 kg
• age 18-60 years

You may not qualify if:

• History of bleeding diathesis
• Relevant drug allergy
• Opioid dependence
• Sepsis
• Those with psychiatric illnesses that would interfere with perception and assessment of pain will be excluded from the study

Sponsors & Collaborators

• South Egypt Cancer Institute: lead

Study Sites (1)

South EGYPT cancer institute

Asyut, 088, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Bupivacaine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• sahar m abd elbaqy, professor

  manager

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant lecturer

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 24, 2017
• Study Start: February 25, 2017
• Primary Completion: May 30, 2017
• Study Completion: June 15, 2017
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)