Local and Intravenous Dexamethasone on Post Operative Pain a After CS

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT02784340

Collaborator

(none)

120

Enrollment

Arms

Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Dexamethasone Drug: Dexamethasone Drug: Saline (IV fluids) Drug: Bupivicaine and Fentany Device: 25G spinal needles	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: IV dexamethasone 40 women received 16 mg Dexamethasone IV drip.	Drug: Dexamethasone 16 mg Dexamethasone IV drip Other Names: dexamethasone sodium phosphate. EIPICO pharmaceutical, Egypt Drug: Bupivicaine and Fentany Device: 25G spinal needles
Active Comparator: Local dexamethasone 40 women received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure	Drug: Dexamethasone 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure Other Names: dexamethasone sodium phosphate USP 8mg/2ml amp. EIPICO pharmaceutical, Egypt Drug: Bupivicaine and Fentany Device: 25G spinal needles
Placebo Comparator: placebo Placebo in the form of IV fluids 500 cc saline infusion	Drug: Saline (IV fluids) IV fluids 500 cc saline infusion Other Names: saline infusion Drug: Bupivicaine and Fentany Device: 25G spinal needles

Arm

Intervention/Treatment

Active Comparator: IV dexamethasone

40 women received 16 mg Dexamethasone IV drip.

Drug: Dexamethasone

16 mg Dexamethasone IV drip

Other Names:

dexamethasone sodium phosphate. EIPICO pharmaceutical, Egypt

Drug: Bupivicaine and Fentany

Device: 25G spinal needles

Active Comparator: Local dexamethasone

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

Drug: Dexamethasone

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

Other Names:

dexamethasone sodium phosphate USP 8mg/2ml amp. EIPICO pharmaceutical, Egypt

Drug: Bupivicaine and Fentany

Device: 25G spinal needles

Placebo Comparator: placebo

Placebo in the form of IV fluids 500 cc saline infusion

Drug: Saline (IV fluids)

IV fluids 500 cc saline infusion

Other Names:

saline infusion

Drug: Bupivicaine and Fentany

Device: 25G spinal needles

Outcome Measures

Primary Outcome Measures

VAS score visual acoustic score [48 hours after CS]
Subjective description of the pain using questionaire

Secondary Outcome Measures

need for additional analgesics [48 hours after CS]
Blood pressure [48 hours after CS]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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