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

NCT ID: NCT04393766

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-23
• Study Completion Date: 2021-09-30

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.

Conditions

PDPH

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

normal saline

Group Type: EXPERIMENTAL

Normal Saline

Intervention Type: DRUG

normal saline(crystalloids)

non normal saline

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

normal saline(crystalloids)

Interventions

Normal Saline

normal saline(crystalloids)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dilla University

OTHER

Sponsor Role: lead

Responsible Party

Semagn Mekonnen

Assistant professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yassin

Addis Ababa, Dilla, Ethiopia

Countries

Ethiopia

Other Identifiers

0014/19-11

Identifier Type: -

Identifier Source: org_study_id