Pain Management in Adult Females in Child Bearing Period Aging From 20 to 45 Years Who Are Scheduled for Elective Cesarean Section
Conditions
Brief summary
Spinal anesthesia is the most commonly used technique for lower abdominal surgeries as it is very economical and easy to administer. However, postoperative pain control is a major problem because spinal anesthesia using only local anesthetics is associated with relatively short duration of action, and thus early analgesic intervention is needed in the postoperative period The transversus abdominus plane (TAP) block is a regional analgesic technique which blocks T6-L1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries
Interventions
DRUGDexmedetomidine
60 Patients will be randomly divided into three equal groups: Group A (n=20) : spinal anesthesia with Dexmedetomidine (5µg ) added to local anesthetic (bupivacaine Hcl ) (10 mg) given intrathecally . Group B (n=20) : spinal anesthesia using local anesthetic( bupivacaine Hcl) (20 mg) combined with TAP block using Dexmedetomidine (20µg ) after the cesarean section Group C (n=20) (controlled group ) : Spinal anesthesia using only local anesthetic (bupivacaine Hcl ) (10 mg) .
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. ASA physical status classes I and II 2. Scheduled for elective cesarean section 3. Aged between 20-45 years .
Exclusion criteria
1. patient refusal. 2. patient with significant cardiovascular disease , hepatic dysfunction , renal failure , chronic pulmonary disease . 3. neuromuscular disorder. 4. infection. 5. bleeding disorder. 6. Obesity ( BMI \> 30 kg/m2 ) . 7. History of allergy or sensitivity to any of the study drugs in previous surgeries .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic efficacy of both routes | 24 hours | Demographic data (age, weight, and length), mean arterial blood pressure (MAP), and heart rate (HR) will be measured every 5 minutes intraoperatively and at 1, 2, 4, 6, 8,12,16,20 and 24 h postoperatively. Visual analog pain score (VAS) between 0 and 10 (0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10=severe pain) will be recorded at 1, 2, 4, 6, 8,16,20 and 24 h postoperatively. First time of rescue analgesia: this is defined as the time from onset of sensory block till the time of first requirement of analgesia. The total amount of rescue analgesia consumption in the form of intravenous ketorolac→0.5 mg/kg if VAS greater than or equal to 4. Any undesirable postoperative side effects (as nausea, vomiting and pruritus) will be recorded and managed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1. Hemodynamic effect on the patient | 1 hour | measuring BP , HR , oxygen saturation during operation every 5 minutes |
Countries
Egypt
Outcome results
None listed