Prophylactic Intrathecal Normal Saline for Prevention of Post Dural Puncture Headache in Women Undergoing Cesarean Section Under Spinal Anesthesia

PDPH Clinical Trial

— PDPH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04393766
• Other study ID #: 0014/19-11
• Status: Completed
• Phase: Phase 4
• Start date: February 23, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2022
• Source: Dilla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: September 30, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• PDPH
• Post-Dural Puncture Headache

Intervention

Drug:
• Normal Saline
normal saline(crystalloids)

Locations

Country	Name	City	State
Ethiopia	Yassin	Addis Ababa	Dilla

Sponsors (1)

Lead Sponsor	Collaborator
Dilla University

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of PDPH	occurance of post dural puncture headache	for five days postoperatively( 12hrs -5 days)
Primary	severity of PDPH	severity of PDPH will be assessed with validated scale( visual analog score)	12hrs to 5 days postoperatively
Secondary	peak sensory block	sensory block	30 minutes after injection of spinal anesthetics
Secondary	motor block	motor block with bromage score	30 minutes after spinal injection