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Local and Intravenous Dexamethasone on Post Operative Pain a After CS

Comparison of Local and Intra Venous Dexamethasone on Post Operative Pain and Recovery After Caeseream Section

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02784340
Enrollment
120
Registered
2016-05-27
Start date
2014-05-31
Completion date
2015-12-31
Last updated
2016-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Postoperative pain, dexamethasone, cesarean section

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.

Interventions

DRUGDexamethasone

16 mg Dexamethasone IV drip

DRUGSaline (IV fluids)

IV fluids 500 cc saline infusion

DRUGBupivicaine and Fentany
DEVICE25G spinal needles

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
VAS score visual acoustic score48 hours after CSSubjective description of the pain using questionaire

Secondary

MeasureTime frame
need for additional analgesics48 hours after CS
Blood pressure48 hours after CS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026