Prophylactic Intrathecal Normal Saline for Prevention of Post Dural Puncture Headache in Women Undergoing Cesarean Section Under Spinal Anesthesia
Condition: PDPH
MeSH terms: Post-Dural Puncture Headache; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      The rates of cesarean section are increasing worldwide despite ten to fifteen percent of
      World Health Organization recommendation and from which 80-90% of cesarean sections are
      performed with spinal anesthesia. Post Dural Puncture Headache is the commonest complications
      associated with spinal anesthesia with prevalence as high as forty percent in Ethiopia. Body
      of evidence revealed that Conservative managements failed to show significant benefit and
      epidural needle and catheter techniques didn't provide conclusive evidences. On the other
      hand, intrathecal injection of normal saline is very safe, simple technique and cost
      effective in resource limited set up but it is not well examined on its efficacy and safety
      profiles. The main objective of the study is to assess of efficacy and safety of prophylactic
      Intrathecal Normal Saline for prevention of Post Dural Puncture Headache in women undergoing
      cesarean section under spinal anesthesia. After Obtaining Ethical clearance from IRB, a
      Randomized Controlled Trial study will be conducted in Dilla University Referral Hospital
      from december2019 to December, 2020. 152 mothers scheduled caesarean section under spinal
      anesthesia fulfilling the inclusion criteria will be allocated into two groups randomly with
      random sequence generated list obtained from R package (Random Allocation Rule function)
      software version 3.6.
    

Detailed description: 
      The rates of cesarean section are increasing worldwide despite ten to fifteen percent of
      World Health Organization recommendation and from which 80-90% of cesarean sections are
      performed with spinal anesthesia. Post Dural Puncture Headache is the commonest complications
      associated with spinal anesthesia with prevalence as high as forty percent in Ethiopia. Body
      of evidence revealed that Conservative managements failed to show significant benefit and
      epidural needle and catheter techniques didn't provide conclusive evidences. On the other
      hand, intrathecal injection of normal saline is very safe, simple technique and cost
      effective in resource limited set up but it is not well examined on its efficacy and safety
      profiles. The main objective of the study is to assess of efficacy and safety of prophylactic
      Intrathecal Normal Saline for prevention of Post Dural Puncture Headache in women undergoing
      cesarean section under spinal anesthesia.

      After Obtaining Ethical clearance from IRB, a Randomized Controlled Trial study will be
      conducted in Dilla University Referral Hospital from October 2019 to May, 2020. 152 mothers
      scheduled caesarean section under spinal anesthesia fulfilling the inclusion criteria will be
      allocated into two groups randomly with random sequence generated list obtained from R
      package (Random Allocation Rule function) software version 3.6. Data will be entered, cleaned
      by Epi-info version 7 and imported to Statistical Package for Social Sciences version 22 for
      analysis. Descriptive statistics will be run to see the overall distribution of the study
      subjects with regard to the variables under study. Unpaired student's T-test for continuous
      symmetric data and Mann Whitney U test for non-normally distributed data will be used to see
      the mean difference between the groups. Categorical data will be analyzed with Chi square and
      fisher's exact test where appropriate. Survival analysis will be done to estimate the
      probability having PDPH within five days postoperatively.
    

Intervention name(s): Normal Saline
Intervention type(s): Drug
Intervention description(s): normal saline(crystalloids)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention