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Local and Intravenous Dexamethasone on Post Operative Pain a After CS

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexamethasone
Dexamethasone
Saline (IV fluids)
Bupivicaine and Fentany
25G spinal needles
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, dexamethasone, cesarean section

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    IV dexamethasone

    Local dexamethasone

    placebo

    Arm Description

    40 women received 16 mg Dexamethasone IV drip.

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

    Placebo in the form of IV fluids 500 cc saline infusion

    Outcomes

    Primary Outcome Measures

    VAS score visual acoustic score
    Subjective description of the pain using questionaire

    Secondary Outcome Measures

    need for additional analgesics
    Blood pressure

    Full Information

    First Posted
    May 20, 2016
    Last Updated
    May 26, 2016
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02784340
    Brief Title
    Local and Intravenous Dexamethasone on Post Operative Pain a After CS
    Official Title
    Comparison of Local and Intra Venous Dexamethasone on Post Operative Pain and Recovery After Caeseream Section
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    No

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    Postoperative pain, dexamethasone, cesarean section

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IV dexamethasone
    Arm Type
    Active Comparator
    Arm Description
    40 women received 16 mg Dexamethasone IV drip.
    Arm Title
    Local dexamethasone
    Arm Type
    Active Comparator
    Arm Description
    40 women received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo in the form of IV fluids 500 cc saline infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Other Intervention Name(s)
    dexamethasone sodium phosphate. EIPICO pharmaceutical, Egypt
    Intervention Description
    16 mg Dexamethasone IV drip
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Other Intervention Name(s)
    dexamethasone sodium phosphate USP 8mg/2ml amp. EIPICO pharmaceutical, Egypt
    Intervention Description
    16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure
    Intervention Type
    Drug
    Intervention Name(s)
    Saline (IV fluids)
    Other Intervention Name(s)
    saline infusion
    Intervention Description
    IV fluids 500 cc saline infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivicaine and Fentany
    Intervention Type
    Device
    Intervention Name(s)
    25G spinal needles
    Primary Outcome Measure Information:
    Title
    VAS score visual acoustic score
    Description
    Subjective description of the pain using questionaire
    Time Frame
    48 hours after CS
    Secondary Outcome Measure Information:
    Title
    need for additional analgesics
    Time Frame
    48 hours after CS
    Title
    Blood pressure
    Time Frame
    48 hours after CS

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed Maged, MD
    Organizational Affiliation
    Kasr Alainy medical school
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29880162
    Citation
    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.
    Results Reference
    derived

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    Local and Intravenous Dexamethasone on Post Operative Pain a After CS

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