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Transverse Abdominal Block for Analgesia in Casarean Section

NCT ID: NCT02122510

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Analgesia Disorder

Keywords

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Analgesia, casarean section, TAP block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Bupivacine group

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Bucaine precdex

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Ayman Abd Al-maksoud Yousef

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayman A Yousef, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor

Ayman A Yousef, MD

Role: STUDY_DIRECTOR

Assistant Professor

Locations

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Tanta University Hospitals

Tanta, Algharbiya, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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1004/02/12

Identifier Type: -

Identifier Source: org_study_id