Local and Intravenous Dexamethasone on Post Operative Pain a After CS

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Device: 25G spinal needles; Drug: Bupivicaine and Fentany; Drug: Dexamethasone; Drug: Saline (IV fluids)

Study type: Interventional

Funder types: Other

Identifiers

NCT02784340

148

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

IV dexamethasone

Active Comparator group

Description:

40 women received 16 mg Dexamethasone IV drip.

Treatment:

Drug: Bupivicaine and Fentany

Drug: Dexamethasone

Device: 25G spinal needles

Drug: Dexamethasone

Local dexamethasone

Active Comparator group

Description:

40 women received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure

Treatment:

Drug: Bupivicaine and Fentany

Drug: Dexamethasone

Device: 25G spinal needles

Drug: Dexamethasone

placebo

Placebo Comparator group

Description:

Placebo in the form of IV fluids 500 cc saline infusion

Treatment:

Drug: Bupivicaine and Fentany

Drug: Saline (IV fluids)

Device: 25G spinal needles