Transverse Abdominal Block for Analgesia in Casarean Section

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT02122510

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia Disorder	Drug: Bupivacine group Drug: Dexmedetomidine	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

The Value of Preemptive Dexmedetomidine Transversus Abdominis Plane (TAP) Block in Patients Undergoing Elective Cesarean Section Under General Anesthesia.

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: dexmetomedine group 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.	Drug: Dexmedetomidine 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 Other Names: precdex
Active Comparator: Bupivacaine group 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.	Drug: Bupivacine group 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 Other Names: Bucaine

Arm

Intervention/Treatment

Active Comparator: dexmetomedine group

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.

Drug: Dexmedetomidine

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

Other Names:

precdex

Active Comparator: Bupivacaine group

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.

Drug: Bupivacine group

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

Other Names:

Bucaine

Outcome Measures

Primary Outcome Measures

hemodynamic changes [2 hours]
blood pressure and heart rate measured every 15 minutes during the intraopertive peroid

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta University Hospitals	Tanta	Algharbiya	Egypt	355217

Sponsors and Collaborators

Tanta University

Investigators

Principal Investigator: Ayman A Yousef, MD, Assistant professor
Study Director: Ayman A Yousef, MD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayman Abd Al-maksoud Yousef, Assistant Professor, Tanta University

ClinicalTrials.gov Identifier:

NCT02122510

Other Study ID Numbers:

1004/02/12

First Posted:

Apr 24, 2014

Last Update Posted:

Dec 16, 2014

Last Verified:

Dec 1, 2014

Keywords provided by Ayman Abd Al-maksoud Yousef, Assistant Professor, Tanta University

Analgesia, casarean section, TAP block

Additional relevant MeSH terms:

Agnosia

Dexmedetomidine

Study Results

No Results Posted as of Dec 16, 2014