search
Back to results

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

Primary Purpose

Breast Cancer Female

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine Injection [Precedex]
Bupivacaine
Sponsored by
South Egypt Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer Female

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • South EGYPT cancer institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group I (Bupivacaine group)

Dexmedetomidine Injection [Precedex]

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

pain relief
by visual analogue scale measurement

Full Information

First Posted
February 8, 2017
Last Updated
February 23, 2017
Sponsor
South Egypt Cancer Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03063073
Brief Title
Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block
Acronym
pec's
Official Title
Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Patient Undergoing Breast Cancer Surgery :A Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 25, 2017 (Anticipated)
Primary Completion Date
May 30, 2017 (Anticipated)
Study Completion Date
June 15, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Egypt Cancer Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (Bupivacaine group)
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Dexmedetomidine Injection [Precedex]
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Injection [Precedex]
Other Intervention Name(s)
[Precedex]
Intervention Description
ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine (markyrene R sigma -Tec, Egypt) plus (1 µg/kg) Dexmedetomidine Injection [Precedex]
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Primary Outcome Measure Information:
Title
I.V patient controlled analgesia (PCA) morphine consumption
Description
the total dose of I.V patient controlled analgesia (PCA) morphine consumption in the first 48 hours postoperative
Time Frame
48 hours postoperative
Secondary Outcome Measure Information:
Title
pain relief
Description
by visual analogue scale measurement
Time Frame
48 hour
Other Pre-specified Outcome Measures:
Title
stress response
Description
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
Time Frame
24 hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohammed f abd elhamed, ass.lecturer
Phone
01015249890
Email
m.farghaly.na@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mohammad f mohammad, lecturer
Phone
01093942354
Email
mfaroukma@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sahar m abd elbaqy, professor
Organizational Affiliation
manager
Official's Role
Study Director
Facility Information:
Facility Name
South EGYPT cancer institute
City
Assuit
ZIP/Postal Code
088
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esam m el sharkawy, prof.
Phone
0882332016
Email
sru@seci.info

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs