Transverse Abdominal Block for Analgesia in Casarean Section

Tanta University

Status: Completed

Conditions: Analgesia Disorder

Treatments: Drug: Dexmedetomidine; Drug: Bupivacine group

Study type: Interventional

Funder types: Other

Identifiers

NCT02122510

1004/02/12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

dexmetomedine group

Active Comparator group

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.

Treatment:

Drug: Dexmedetomidine

Bupivacaine group

Active Comparator group

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.

Treatment:

Drug: Bupivacine group