Local and Intravenous Dexamethasone on Post Operative Pain a After CS
- Conditions
- Postoperative Pain
- Interventions
- Registration Number
- NCT02784340
- Lead Sponsor
- Cairo University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
- All participants were scheduled for elective cesarean section under spinal anaesthesia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IV dexamethasone Bupivicaine and Fentany 40 women received 16 mg Dexamethasone IV drip. IV dexamethasone 25G spinal needles 40 women received 16 mg Dexamethasone IV drip. Local dexamethasone Bupivicaine and Fentany 40 women received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure Local dexamethasone 25G spinal needles 40 women received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure placebo Saline (IV fluids) Placebo in the form of IV fluids 500 cc saline infusion placebo Bupivicaine and Fentany Placebo in the form of IV fluids 500 cc saline infusion placebo 25G spinal needles Placebo in the form of IV fluids 500 cc saline infusion IV dexamethasone Dexamethasone 40 women received 16 mg Dexamethasone IV drip. Local dexamethasone Dexamethasone 40 women received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure
- Primary Outcome Measures
Name Time Method VAS score visual acoustic score 48 hours after CS Subjective description of the pain using questionaire
- Secondary Outcome Measures
Name Time Method need for additional analgesics 48 hours after CS Blood pressure 48 hours after CS