Adding Different Additives to Bupivacaine-fentanyl Mixture in Spinal Anesthesia for Cesarean Section
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
spinal anaesthesia
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- 90 parturient
- the statue of American Society of Anesthesiologists' physical class II
- prepared for an elective cesarean section.
Exclusion Criteria:
- BMI > 35kg/m2
- gestational age < 28 weeks
- diabetes or gestational diabetes
- hypertension or pre-eclampsia
- contraindications to spinal anesthesia
- height less than 160 Cm
- history of psychiatric disease
- taking α-receptor antagonist drugs -a history of allergy to the study drugs-
- excessive hemorrhage needing transfusion.
Sites / Locations
- Tarek Abdel Hay
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
control group
Dexmedetomidine group):
Dexamethasone group
Arm Description
spinal anesthesia with 10 mg hyperbaric bupivacaine 5% (2 ml) + 25 μg fentanyl (0.5 ml) + normal saline (0.5 ml).
spinal anesthesia with 10 mg hyperbaric bupivacaine 5% (2 ml) + 25 μg fentanyl (0.5 ml) + 5 μg dexmedetomidine in a volume of (0.5 ml).
spinal anaesthesia with 10 mg hyperbaric bupivacaine 5% (2 ml) + 25 μg fentanyl (0.5 ml) + 2 mg dexamethasone in a volume of 0.5 ml).
Outcomes
Primary Outcome Measures
time for the first request of rescue analgesia
time for the first request of rescue morphine analgesia at dose of 3 mg
Secondary Outcome Measures
Numerical Rating Scale
Numerical Rating Scale (NRS) for pain that ranged from (0 = no pain) to (10 = intolerable pain). If score is >3 will need analgesia in the form of morphine 3 mg will be given till NRS decreases to ≤3. NRS will be assessed and recorded immediately postoperative, 2, 4, 8, 12, 18, 24 h after the operation, by an anesthesiologist, who is blinded to the study groups.
Maternal satisfaction
Maternal satisfaction will be evaluated on a 0-3 score (0 = poor, 1 = fair, 2 = good, and 3 = excellent).
Neonatal outcome
Neonatal outcome will be assessed in terms of Apgar score.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04464616
Brief Title
Adding Different Additives to Bupivacaine-fentanyl Mixture in Spinal Anesthesia for Cesarean Section
Official Title
The Effect of Adding Dexmedetomidine or Dexamethasone to Bupivacaine-Fentanyl Mixture in Spinal Anesthesia for Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
January 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Spinal anesthesia is widely used in cesarean section, but it is associated with high incidence of side effects. To reduce the occurrence of side effects, intrathecal adjuvant was recommended to use in spinal anesthesia, with the aim in reducing the dose of intrathecal local anesthetic, which can subsequently decrease the incidence of spinal-induced side effects and prolong postoperative analgesia.
Detailed Description
Spinal anesthesia is widely used in cesarean section, but it is associated with high incidence of side effects. To reduce the occurrence of side effects, intrathecal adjuvant was recommended to use in spinal anesthesia, with the aim in reducing the dose of intrathecal local anesthetic, which can subsequently decrease the incidence of spinal-induced side effects and prolong postoperative analgesia.Many augmentation strategies for intrathecal analgesia have been proposed. A meta-analysis by Popping et al. concluded that the concomitant use of an opioid such as fentanyl intrathecally allows the reduction in the dose of local anesthetic, while augmenting its analgesic potency thereby decreasing its adverse effects.
Dexamethasone relieves pain through reducing inflammation and blocking of nociceptive C- fibers transmission and by suppressing neural ectopic discharge. Post-operative analgesic effectiveness and duration was prolonged when dexamethasone was used as an adjunct for peripheral nerve blocks. Recent studies reported no complications associated with intrathecal dexamethasone.
Dexmedetomidine (DEX) is a potent, selective α2 adrenergic agonist and when given intrathecally, it exerts its analgesic effect via stimulating spinal α2 receptors. Wu et al., in their meta-analysis showed that addition of intrathecal DEX significantly increased the duration of postoperative analgesia and reduced analgesic consumption. The increase in duration of postoperative analgesia is dose dependent but with increase in the incidence of bradycardia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
spinal anesthesia with 10 mg hyperbaric bupivacaine 5% (2 ml) + 25 μg fentanyl (0.5 ml) + normal saline (0.5 ml).
Arm Title
Dexmedetomidine group):
Arm Type
Experimental
Arm Description
spinal anesthesia with 10 mg hyperbaric bupivacaine 5% (2 ml) + 25 μg fentanyl (0.5 ml) + 5 μg dexmedetomidine in a volume of (0.5 ml).
Arm Title
Dexamethasone group
Arm Type
Experimental
Arm Description
spinal anaesthesia with 10 mg hyperbaric bupivacaine 5% (2 ml) + 25 μg fentanyl (0.5 ml) + 2 mg dexamethasone in a volume of 0.5 ml).
Intervention Type
Procedure
Intervention Name(s)
spinal anaesthesia
Other Intervention Name(s)
intrathecal anaesthesia
Intervention Description
spinal anaesthesia will be performed with the patient in sitting position at the L3-L4 or L4-L5 interspaces with a 25 or 27 G spinal tip needle with the study drug in the total volume of 3 ml.
Primary Outcome Measure Information:
Title
time for the first request of rescue analgesia
Description
time for the first request of rescue morphine analgesia at dose of 3 mg
Time Frame
postoperative first day
Secondary Outcome Measure Information:
Title
Numerical Rating Scale
Description
Numerical Rating Scale (NRS) for pain that ranged from (0 = no pain) to (10 = intolerable pain). If score is >3 will need analgesia in the form of morphine 3 mg will be given till NRS decreases to ≤3. NRS will be assessed and recorded immediately postoperative, 2, 4, 8, 12, 18, 24 h after the operation, by an anesthesiologist, who is blinded to the study groups.
Time Frame
postoperative first day
Title
Maternal satisfaction
Description
Maternal satisfaction will be evaluated on a 0-3 score (0 = poor, 1 = fair, 2 = good, and 3 = excellent).
Time Frame
postoperative first day
Title
Neonatal outcome
Description
Neonatal outcome will be assessed in terms of Apgar score.
Time Frame
time of delivery of fetus
10. Eligibility
Sex
Female
Gender Based
Yes
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
90 parturient
the statue of American Society of Anesthesiologists' physical class II
prepared for an elective cesarean section.
Exclusion Criteria:
BMI > 35kg/m2
gestational age < 28 weeks
diabetes or gestational diabetes
hypertension or pre-eclampsia
contraindications to spinal anesthesia
height less than 160 Cm
history of psychiatric disease
taking α-receptor antagonist drugs -a history of allergy to the study drugs-
excessive hemorrhage needing transfusion.
Facility Information:
Facility Name
Tarek Abdel Hay
City
Tanta
State/Province
El Gharbyia
ZIP/Postal Code
31527
Country
Egypt
12. IPD Sharing Statement
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Adding Different Additives to Bupivacaine-fentanyl Mixture in Spinal Anesthesia for Cesarean Section
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