Clinical trial NCT04393766: Prophylactic Intrathecal Normal Saline for Prevention of Post Dural Puncture Headache in Women Undergoing Cesarean Section Under Spinal Anesthesia
Official title: Effectiveness of Prophylactic Intrathecal Normal Saline for Prevention of Post Dural Puncture Headache in Women Undergoing Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PDPH
Lead sponsor: Dilla University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 152
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* American society of anesthesiologists' physical status classification(ASA I and II)
* Term pregnant lady

Exclusion Criteria:

* patient whose ASA status was greater than three
* previous history of PDPH
* previous history of migraine headache
* BMI greater than 25 kg/m2

Primary outcomes:
measure: incidence of PDPH
timeFrame: for five days postoperatively( 12hrs -5 days)
measure: severity of PDPH
timeFrame: 12hrs to 5 days postoperatively
Secondary outcomes:
measure: peak sensory block
timeFrame: 30 minutes after injection of spinal anesthetics
measure: motor block
timeFrame: 30 minutes after spinal injection
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Yassin
state: Dilla
Study officials:
References: