The Value of Preemptive Dexmedetomidine Transversus Abdominis Plane (TAP) Block in Patients Undergoing Elective Cesarean Section Under General Anesthesia.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- hemodynamic changes
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Dexmedetomidine (Drug)
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.
Intervention: Bupivacine group (Drug)
Outcomes
Primary Outcomes
hemodynamic changes
Time Frame: 2 hours
blood pressure and heart rate measured every 15 minutes during the intraopertive peroid
Secondary Outcomes
- Analgesic requirements(24 hours)
Investigators
Ayman Abd Al-maksoud Yousef
Assistant Professor
Tanta University