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

NCT04393766 | Completed Phase 4

• 1 other identifier: 0014/19-11
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

PDPH

Outcome Measures

Primary Outcomes (2)

• incidence of PDPH

  occurance of post dural puncture headache

  for five days postoperatively( 12hrs -5 days)

• severity of PDPH

  severity of PDPH will be assessed with validated scale( visual analog score)

  12hrs to 5 days postoperatively

Secondary Outcomes (2)

• peak sensory block

  30 minutes after injection of spinal anesthetics

• motor block

  30 minutes after spinal injection

Study Arms (2)

normal saline

EXPERIMENTAL

Drug: Normal Saline

non normal saline

PLACEBO COMPARATOR

Drug: Normal Saline

Interventions

Normal Saline DRUG

normal saline(crystalloids)

non normal saline; normal saline

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dilla University: lead

Study Sites (1)

Yassin

Addis Ababa, Dilla, 00419, Ethiopia

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: after random generation sequence, the list of 152 were sealed with envelope which later opened by research assistance
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesiology

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: February 23, 2020
• Primary Completion: August 23, 2021
• Study Completion: September 30, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

ET (1)