Transverse Abdominal Block for Analgesia in Casarean Section

Analgesia Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122510
• Other study ID #: 1004/02/12
• Status: Completed
• Phase: N/A
• First received: April 22, 2014
• Last updated: December 14, 2014
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2014
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

Inclusion Criteria:

1. We will study 60 ASA [American Society of Anesthesiologist] physical status I and ?? 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Analgesia Disorder

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	Algharbiya

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemodynamic changes	blood pressure and heart rate measured every 15 minutes during the intraopertive peroid	2 hours	Yes
Secondary	Analgesic requirements	VAS will be measured during 24 hours after surgery every 4 hours	24 hours	Yes