Intrathecal Dexmedetomidine Versus Transversus Abdominus Plane Block (TAP) for Postoperative Analgesia After Cesarean Section.
NCT ID: NCT04969705
Last Updated: 2022-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-01-01
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A (spinal Dexmedetomidine)
. 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.
Dexmedetomidine
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) .
Group B (spinal with transversus abdominus plane block)
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.
Dexmedetomidine
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) .
Group C ( controlled group ) Spinal Anesthesia only :
Patients will be anesthetized only with spinal anesthesia using Bupivacaine Hcl( 10 mg).
Dexmedetomidine
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) .
Interventions
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Dexmedetomidine
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) .
Eligibility Criteria
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Inclusion Criteria
2. Scheduled for elective cesarean section
3. Aged between 20-45 years .
Exclusion Criteria
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 .
20 Years
45 Years
FEMALE
Yes
Sponsors
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Sohag University
OTHER
Responsible Party
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Dina Mostafa Helmy
resident doctor
Locations
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Sohag University Hospital
Sohag, , Egypt
Countries
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References
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Betran AP, Merialdi M, Lauer JA, Bing-Shun W, Thomas J, Van Look P, Wagner M. Rates of caesarean section: analysis of global, regional and national estimates. Paediatr Perinat Epidemiol. 2007 Mar;21(2):98-113. doi: 10.1111/j.1365-3016.2007.00786.x.
Madadi P, Ross CJ, Hayden MR, Carleton BC, Gaedigk A, Leeder JS, Koren G. Pharmacogenetics of neonatal opioid toxicity following maternal use of codeine during breastfeeding: a case-control study. Clin Pharmacol Ther. 2009 Jan;85(1):31-5. doi: 10.1038/clpt.2008.157. Epub 2008 Aug 20.
Elia N, Culebras X, Mazza C, Schiffer E, Tramer MR. Clonidine as an adjuvant to intrathecal local anesthetics for surgery: systematic review of randomized trials. Reg Anesth Pain Med. 2008 Mar-Apr;33(2):159-67. doi: 10.1016/j.rapm.2007.10.008.
Other Identifiers
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Soh-Med-21-07-03
Identifier Type: -
Identifier Source: org_study_id
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