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

Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Patient Undergoing Breast Cancer Surgery :A Comparative Study

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).

Study Overview

• Status: Unknown
• Conditions: Breast Cancer Female
• Intervention / Treatment: Drug: Bupivacaine; Drug: Dexmedetomidine Injection [Precedex]

Detailed Description

60 patients scheduled for modified radical mastectomy surgery under general anesthesia. Group I (Bupivacaine group): patients underwent modified radical mastectomy were given preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles on the interfascial plane, and 20 ml injected between the Pectoralis minor muscle and the serratus muscle.Group II (Bupivacaine + Dexmedetomidine group) : preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg) divided into 20 ml injected between the pectoralis muscles on the interfascial plane , and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: mohammed f abd elhamed, ass.lecturer; Phone Number: 01015249890; Email: m.farghaly.na@gmail.com
• Study Contact Backup: Name: mohammad f mohammad, lecturer; Phone Number: 01093942354; Email: mfaroukma@gmail.com

Study Locations

• Egypt
  • Assuit, Egypt, 088
    • South Egypt Cancer Institute
    • Contact: Esam m el sharkawy, prof.; Phone Number: 0882332016; Email: sru@seci.info

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA I - II patients

  • weight 50- 100 kg
• age 18-60 years

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group I (Bupivacaine group); 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
Active Comparator: Dexmedetomidine Injection [Precedex]; 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: Bupivacaine; Drug: Dexmedetomidine Injection [Precedex]; ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine (markyrene R sigma -Tec, Egypt) plus (1 µg/kg) Dexmedetomidine Injection [Precedex]; Other Names: [Precedex]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain relief	by visual analogue scale measurement	48 hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
stress response	Three Blood samples were collected from each patient for detection of cortisol & prolactin levels, the first was preoperative, the second and the third were 1h and 24 h postoperatively	24 hour

Collaborators and Investigators

• Sponsor: South Egypt Cancer Institute
• Investigators: Study Director: sahar m abd elbaqy, professor, manager

Study record dates

Study Major Dates

• Study Start (Anticipated): February 25, 2017
• Primary Completion (Anticipated): May 30, 2017
• Study Completion (Anticipated): June 15, 2017

Study Registration Dates

• First Submitted: February 8, 2017
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: 224 (registration study)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No