Analgesia
Conditions
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
Interventions
DRUGDexmedetomidine 0.5 mcg
0.5 mcg/kg
DRUGDexmedetomidine 1 mcg
1 mcg/kg
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
The injectate used for TAPB will be prepared according to the group by an anesthesiologist who won't be involved in the data collection
Intervention 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
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time of the first postoperative analgesic requirement | during the first 24 postoperative hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The visual analog scale (VAS) scores during rest | during the first 24 postoperative hours | 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 |
| The visual analog scale (VAS) scores during movement | during the first 24 postoperative hours | 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 |
| Mean arterial blood pressure (MBP) | basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours | mmHg |
| heart rate (HR) | basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours | beat per minute |
| Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the | during the first 24 postoperative hours | mg |
| The side effects (nausea, vomiting, abdominal colic and lower limb weakness) | during the first 24 postoperative hours | incidence |
| the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome | during the first 24 postoperative hours | — |
| The level of sedation | during the first 24 postoperative hours | 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) |
| Patient satisfaction about the quality of postoperative analgesia | during the first 24 postoperative hours | poor = 1, fair = 2, good = 3, excellent = 4 |
Countries
Egypt
Outcome results
None listed