Different Doses of Dexmedetomidine Added to Bupivacaine in Transversus Abdominis Plane Block in Caesarean Delivery

Study Overview
=================
Brief Summary
-----------------
Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern. Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine) Dexmedetomidine is a potent and highly selective α2 adrenergic receptor agonist, exerts its sympatholytic effect by inhibiting the release of noradrenaline from central and peripheral sympathetic nerve endings. It is considered to be a useful agent with a wide safety margin, excellent sedative capacity and moderate analgesic properties

Detailed Description
-----------------
This prospective double-blinded randomized controlled study will be done on parturients that are scheduled for elective cesarean delivery under spinal anesthesia to assess the efficacy of two different doses (0.5 mcg/kg and 1mcg/kg) of dexmedetomidine as an adjuvant to isobaric bupivacaine in TAPB compared to a control group on the postoperative analgesia in cesarean section under spinal anaesthesia

Official Title
-----------------
Comparison Between Two Different Doses of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block for Postoperative Analgesia in Caesarean Delivery

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine 0.5 mcg
* Drug: Dexmedetomidine 1 mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 19 to 40 years old American Society of Anesthesiologists (ASA) physical status II patients Singleton pregnancies with a gestational age of at least 37 weeks. Patients undergoing spinal anesthesia for cesarean delivery via a Pfannenstiel incision with exteriorization of the uterus. Exclusion Criteria: Age < 19 or > 40 years. Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2. Inability to comprehend or participate in the pain scoring system. Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection). Hypersensitivity to any drug used in the study. Any hypertensive disorders of pregnancy. Renal impairment or other contraindications to non-steroidal anti-infilamatory drugs (NSAIDS). Significant cardiovascular, renal or hepatic abnormalities. Patients with history of opioid intake, drug abusers or psychiatric patients

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: according to the computer-generated random number codes that will be placed in sealed envelopes, the patients will be randomly allocated into three groups; Group-Control, Group-Dexmedetomidine 0.5 and Group-Dexmedetomidine 1 according tho the local anesthetic injected in Ultrasound-guided bilateral Tranversus abdominis plane block
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group-Control<br>After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0.5% plus 10 mL normal saline 0.9% for each side | |
| Active Comparator: Group-Dexmedetomidine 0.5<br>After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0.5% plus 10 mL normal saline containing 0.5 mcg/kg dexmedetomidine for each side | Drug: Dexmedetomidine 0.5 mcg<br>* 0.5 mcg/kg<br>|
| Active Comparator: Group-Dexmedetomidine1<br>After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0. 5% plus 10 mL normal saline containing 1 mcg/kg dexmedetomidine for each side | Drug: Dexmedetomidine 1 mcg<br>* 1 mcg/kg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time of the first postoperative analgesic requirement |  | during the first 24 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the | mg | during the first 24 postoperative hours | 
| The visual analog scale (VAS) scores during rest | 11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively | during the first 24 postoperative hours | 
| The visual analog scale (VAS) scores during movement | 11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively | during the first 24 postoperative hours | 
| Mean arterial blood pressure (MBP) | mmHg | basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours | 
| heart rate (HR) | beat per minute | basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours | 
| Patient satisfaction about the quality of postoperative analgesia | poor = 1, fair = 2, good = 3, excellent = 4 | during the first 24 postoperative hours | 
| The side effects (nausea, vomiting, abdominal colic and lower limb weakness) | incidence | during the first 24 postoperative hours | 
| the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome |  | during the first 24 postoperative hours | 
| The level of sedation | using a 4-point scale (0 = awake and alert, 1 = minimally sedated, responds to speech, 2 = moderately sedated, arousable by tactile stimulation, and 3 = deeply sedated, arousable only by painful stimulation) | during the first 24 postoperative hours |