Local and Intravenous Dexamethasone on Post Operative Pain a After CS

May 26, 2016 updated by: Ahmed Maged, Cairo University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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: 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
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 IV drip
Other Names:
  • dexamethasone sodium phosphate. EIPICO pharmaceutical, Egypt
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: Bupivicaine and Fentany
Device: 25G spinal needles
Drug: Saline (IV fluids)
IV fluids 500 cc saline infusion
Other Names:
  • saline infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS score visual acoustic score
Time Frame: 48 hours after CS
Subjective description of the pain using questionaire
48 hours after CS

Secondary Outcome Measures

Outcome Measure
Time Frame
need for additional analgesics
Time Frame: 48 hours after CS
48 hours after CS
Blood pressure
Time Frame: 48 hours after CS
48 hours after CS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

May 26, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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