Transverse Abdominal Block for Analgesia in Casarean Section

NCT02122510 | Completed DMC

• 1 other identifier: 1004/02/12
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia Disorder

Keywords

Analgesia, casarean section, TAP block

Outcome Measures

Primary Outcomes (1)

• hemodynamic changes

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

  2 hours

Secondary Outcomes (1)

• Analgesic requirements

  24 hours

Study Arms (2)

dexmetomedine group

ACTIVE COMPARATOR

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

Bupivacaine group

ACTIVE COMPARATOR

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

Interventions

Bupivacine group 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

Also known as: Bucaine

Bupivacaine group

Dexmedetomidine 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

Also known as: precdex

dexmetomedine group

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Algharbiya, 355217, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ayman A Yousef, MD

  Assistant professor

  PRINCIPAL INVESTIGATOR

• Ayman A Yousef, MD

  Assistant Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 24, 2014
• Study Start: March 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

EG (1)