Analgesia Disorder
Conditions
Keywords
Analgesia, casarean section, TAP block
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.
Interventions
DRUGBupivacine 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
DRUGDexmedetomidine
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
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hemodynamic changes | 2 hours | blood pressure and heart rate measured every 15 minutes during the intraopertive peroid |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic requirements | 24 hours | VAS will be measured during 24 hours after surgery every 4 hours |
Countries
Egypt
Outcome results
None listed