Intrathecal Dexmedetomidine Versus Transversus Abdominus Plane Block (TAP) for Postoperative Analgesia After Cesarean Section.

Sohag University

Status: Completed

Conditions: Pain Management in Adult Females in Child Bearing Period Aging From 20 to 45 Years Who Are Scheduled for Elective Cesarean Section

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04969705

Soh-Med-21-07-03

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Group A (spinal Dexmedetomidine)

Active Comparator group

Description:

. Spinal needles (22 G) will be introduced in sitting position after skin disinfection with povidine iodine, iliac crest will be palpated and thumb extended to meet the midline, feeling the space between L4 and L5. spinal needle penetrates through the dura matter, a pop will be felt and then after the needle puncture into the subarachnoid space and the appearance of clear cerebrospinal fluid, the intrathecal local anesthetic will be injected. All patients will be receiving 2 ml heavy bupivacaine 0.5% plus 5 µg dexmedetomidine to total volume of 2.5 ml.

Treatment:

Drug: Dexmedetomidine

Group B (spinal with transversus abdominus plane block)

Active Comparator group

Description:

Spinal needles (22 G) introduced in sitting position . patients receiving1.7 to 2.2 ml heavy bupivacaine 0.5%( according to weight and height ) + 1 ml normal saline = total volume of 2.5 ml then at surgery end under sonographic guide transducer placed in transverse plane above iliac crest.A 90 mm 22 G short beveled block needle inserted in-plane with transducer, in anterior-posterior direction. needle connected to syringe contains20 ml of bupivacaine 0.25%+10 µg dexmedetomidine to deposit local anesthetic deep into the fascial layer between internal oblique \& transversus abdominis muscles on each side.

Treatment:

Drug: Dexmedetomidine

Group C ( controlled group ) Spinal Anesthesia only :

Active Comparator group

Description:

Patients will be anesthetized only with spinal anesthesia using Bupivacaine Hcl( 10 mg).

Treatment:

Drug: Dexmedetomidine