Local and Intravenous Dexamethasone on Post Operative Pain a After CS

NCT ID: NCT02784340

Last Updated: 2016-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-12-31

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IV dexamethasone

40 women received 16 mg Dexamethasone IV drip.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

16 mg Dexamethasone IV drip

Bupivicaine and Fentany

Intervention Type: DRUG

25G spinal needles

Intervention Type: DEVICE

Local dexamethasone

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

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

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

Bupivicaine and Fentany

Intervention Type: DRUG

25G spinal needles

Intervention Type: DEVICE

placebo

Placebo in the form of IV fluids 500 cc saline infusion

Group Type: PLACEBO_COMPARATOR

Saline (IV fluids)

Intervention Type: DRUG

IV fluids 500 cc saline infusion

Bupivicaine and Fentany

Intervention Type: DRUG

25G spinal needles

Intervention Type: DEVICE

Interventions

Dexamethasone

16 mg Dexamethasone IV drip

Intervention Type: DRUG

Dexamethasone

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

Intervention Type: DRUG

Saline (IV fluids)

IV fluids 500 cc saline infusion

Intervention Type: DRUG

Bupivicaine and Fentany

Intervention Type: DRUG

25G spinal needles

Intervention Type: DEVICE

Other Intervention Names

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

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Maged

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Kasr Alainy medical school

References

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.

Reference Type: DERIVED

PMID: 29880162 (View on PubMed)

Other Identifiers

148

Identifier Type: -

Identifier Source: org_study_id