Local and Intravenous Dexamethasone on Post Operative Pain a After CS
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexamethasone
Dexamethasone
Saline (IV fluids)
Bupivicaine and Fentany
25G spinal needles
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, dexamethasone, cesarean section
Eligibility Criteria
Inclusion Criteria:
- All participants were scheduled for elective cesarean section under spinal anaesthesia
Exclusion Criteria:
- Women with neurological disorders
- Psychologically disturbed
- Those with uncontrolled hypertension, Diabetes Mellitus, peptic ulcer, liver cirrhosis or glaucoma
- Women with systemic infections
- Allergy to Dexamethasone
- Contraindications to spinal anaesthesia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
IV dexamethasone
Local dexamethasone
placebo
Arm Description
40 women received 16 mg Dexamethasone IV drip.
40 women received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure
Placebo in the form of IV fluids 500 cc saline infusion
Outcomes
Primary Outcome Measures
VAS score visual acoustic score
Subjective description of the pain using questionaire
Secondary Outcome Measures
need for additional analgesics
Blood pressure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02784340
Brief Title
Local and Intravenous Dexamethasone on Post Operative Pain a After CS
Official Title
Comparison of Local and Intra Venous Dexamethasone on Post Operative Pain and Recovery After Caeseream Section
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Prospective, randomized study conducted on 120 pregnant women attending the labour wards in Kasr Al Ainy and Fayoum maternity hospitals from May 2014 to December 2015. All participants were scheduled for elective cesarean section under spinal anaesthesia and were randomly divided into 3 equal groups. Group 1(40 women) received 16 mg Dexamethasone IV drip. Group II (40 women) received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure and Group III received Placebo in the form of IV fluids 500 cc saline infusion. All cases were followed up for 48 hours for assessment of level of pain by using a 10-cm visual analog scale (VAS). Primary outcome parameters were VAS score and the need for additional analgesics. Other parameters were hemodynamic changes and occurrence of side effects or complications
Detailed Description
The patients were subjected to history taking, including age, parity, menstrual history for verification of gestational age and medical history for confirmation of inclusion and exclusion criteria. Full general and abdominal and obstetric examinations were done. Investigations including complete blood picture, liver functions and coagulation profile to exclude those not fitting with the above listed criteria. Ultrasound was done to assess gestational age.
Patients were checked for coagulation abnormalities. Large gauge (18G) cannula was inserted in cephalic or ante cubital veins. Patients were preloaded with HAES- steril 6% (hydroxyl ethyl starch) Fresenius. Or, preloaded with ringer's lactate 20 ml/kg. Patients were positioned in the sitting position for spinal anaesthesia and sterilization of the back was done using Betadine. L3-L4 space was determined for the insertion of spinal needle. Then 25G spinal needle was used to perform a single shot spinal anaesthesia using 10mg of 0.5% hyperbaric Bupivicaine and Fentanyl 20 micrograms.
All surgeons had close surgical skills and used the same technique transverse lower segment incision.
The procedure is then completed using traction on cord to deliver the placenta, exteriorization of uterus, closure of uterine incision in 2 layers, closure of both visceral and parietal peritoneum, closure of rectus sheath, no subcutaneous closure and finally subcuticular skin closure. Follow up for all cases for 48 hours. Primary outcome parameters were VAS score and the need for additional analgesics. Other parameters were hemodynamic changes and occurrence of side effects or complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain, dexamethasone, cesarean section
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV dexamethasone
Arm Type
Active Comparator
Arm Description
40 women received 16 mg Dexamethasone IV drip.
Arm Title
Local dexamethasone
Arm Type
Active Comparator
Arm Description
40 women received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo in the form of IV fluids 500 cc saline infusion
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
dexamethasone sodium phosphate. EIPICO pharmaceutical, Egypt
Intervention Description
16 mg Dexamethasone IV drip
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
dexamethasone sodium phosphate USP 8mg/2ml amp. EIPICO pharmaceutical, Egypt
Intervention Description
16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure
Intervention Type
Drug
Intervention Name(s)
Saline (IV fluids)
Other Intervention Name(s)
saline infusion
Intervention Description
IV fluids 500 cc saline infusion
Intervention Type
Drug
Intervention Name(s)
Bupivicaine and Fentany
Intervention Type
Device
Intervention Name(s)
25G spinal needles
Primary Outcome Measure Information:
Title
VAS score visual acoustic score
Description
Subjective description of the pain using questionaire
Time Frame
48 hours after CS
Secondary Outcome Measure Information:
Title
need for additional analgesics
Time Frame
48 hours after CS
Title
Blood pressure
Time Frame
48 hours after CS
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All participants were scheduled for elective cesarean section under spinal anaesthesia
Exclusion Criteria:
Women with neurological disorders
Psychologically disturbed
Those with uncontrolled hypertension, Diabetes Mellitus, peptic ulcer, liver cirrhosis or glaucoma
Women with systemic infections
Allergy to Dexamethasone
Contraindications to spinal anaesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
Kasr Alainy medical school
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29880162
Citation
Maged AM, Deeb WS, Elbaradie S, Elzayat AR, Metwally AA, Hamed M, Shaker A. Comparison of local and intra venous dexamethasone on post operative pain and recovery after caeseream section. A randomized controlled trial. Taiwan J Obstet Gynecol. 2018 Jun;57(3):346-350. doi: 10.1016/j.tjog.2018.04.004.
Results Reference
derived
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Local and Intravenous Dexamethasone on Post Operative Pain a After CS
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