Local and Intravenous Dexamethasone on Post Operative Pain a After CS
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Dexamethasone; Dexamethasone; Saline (IV fluids); Bupivicaine and Fentany; 25G spinal needles
Intervention type(s): Drug; Drug; Drug; Drug; Device
Intervention description(s): 16 mg Dexamethasone IV drip; 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure; IV fluids 500 cc saline infusion
Other intervention name(s): dexamethasone sodium phosphate. EIPICO pharmaceutical, Egypt; dexamethasone sodium phosphate USP 8mg/2ml amp. EIPICO pharmaceutical, Egypt; saline infusion
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Bupivacaine; Dexamethasone 21-phosphate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative pain; dexamethasone; cesarean section