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Transverse Abdominal Block for Analgesia in Casarean Section

Primary Purpose

Analgesia Disorder

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacine group
Dexmedetomidine
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Analgesia Disorder focused on measuring Analgesia, casarean section, TAP block

Eligibility Criteria

21 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. We will study 60 ASA [American Society of Anesthesiologist] physical status I and ІІ patients undergoing elective cesarean delivery
  2. Age between 21-40 years old.

Exclusion Criteria:

  1. Refusal of participation in the study
  2. Patients who have infection or tumor at the site of puncture for local anesthetic injection.
  3. Patients who have coagulopathy, platelet abnormalities, and concurrent treatment with anticoagulant drugs.
  4. Patients known to have allergy or sensitivity to dexmetomedine, and/or bupivacaine
  5. Severe hepatic and/or renal insufficiency
  6. Morbid obesity (body mass index (BMI) >35)
  7. Psychological disease

Sites / Locations

  • Tanta University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

dexmetomedine group

Bupivacaine group

Arm Description

dexmetomedine group will receive pre-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe labeled G 2.

Bupivacaine group will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline in 20 ml syringe labeled G 2.

Outcomes

Primary Outcome Measures

hemodynamic changes
blood pressure and heart rate measured every 15 minutes during the intraopertive peroid

Secondary Outcome Measures

Analgesic requirements
VAS will be measured during 24 hours after surgery every 4 hours

Full Information

First Posted
April 22, 2014
Last Updated
December 14, 2014
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT02122510
Brief Title
Transverse Abdominal Block for Analgesia in Casarean Section
Official Title
The Value of Preemptive Dexmedetomidine Transversus Abdominis Plane (TAP) Block in Patients Undergoing Elective Cesarean Section Under General Anesthesia.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, the investigators will compare the analgesic effect of bupivacaine and bupivacaine-dexmetomedine after elective cesarean delivery by performing an bilateral TAP block, on the patients for whom the operation will be performed under general anesthesia.
Detailed Description
The investigators will study 60 ASA [American Society of Anesthesiologist] physical status I and ІІ patients undergoing elective cesarean delivery at tanta University Hospital, in a prospective, randomized, comparative, clinical trial. Patients will be randomly allocated to two equal groups (n = 30) using closed envelopes labeled 1,and 2 reflecting group 1and 2 respectively. The drugs are prepared by the anesthesiologist who is not involved in the study or data collection. Group I: (n=30) will receive pre-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe labeled G 2. Group II: (n=30) will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline in 20 ml syringe labeled G2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia Disorder
Keywords
Analgesia, casarean section, TAP block

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dexmetomedine group
Arm Type
Active Comparator
Arm Description
dexmetomedine group will receive pre-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe labeled G 2.
Arm Title
Bupivacaine group
Arm Type
Active Comparator
Arm Description
Bupivacaine group will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline in 20 ml syringe labeled G 2.
Intervention Type
Drug
Intervention Name(s)
Bupivacine group
Other Intervention Name(s)
Bucaine
Intervention Description
Bupivacaine group(n=30) will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
precdex
Intervention Description
Dexamedtomedine group will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe
Primary Outcome Measure Information:
Title
hemodynamic changes
Description
blood pressure and heart rate measured every 15 minutes during the intraopertive peroid
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Analgesic requirements
Description
VAS will be measured during 24 hours after surgery every 4 hours
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: We will study 60 ASA [American Society of Anesthesiologist] physical status I and ІІ patients undergoing elective cesarean delivery Age between 21-40 years old. Exclusion Criteria: Refusal of participation in the study Patients who have infection or tumor at the site of puncture for local anesthetic injection. Patients who have coagulopathy, platelet abnormalities, and concurrent treatment with anticoagulant drugs. Patients known to have allergy or sensitivity to dexmetomedine, and/or bupivacaine Severe hepatic and/or renal insufficiency Morbid obesity (body mass index (BMI) >35) Psychological disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman A Yousef, MD
Organizational Affiliation
Assistant professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayman A Yousef, MD
Organizational Affiliation
Assistant Professor
Official's Role
Study Director
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
State/Province
Algharbiya
ZIP/Postal Code
355217
Country
Egypt

12. IPD Sharing Statement

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Transverse Abdominal Block for Analgesia in Casarean Section

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