Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache

Phase 4

Completed

• Conditions: Headache
• Interventions: Drug: hydrocortisone 100mg.; Drug: mannitol 20% intravenous fluid

• Registration Number: NCT02760862
• Lead Sponsor: Ain Shams University

Brief Summary

Fifty patients of both sex, aged 18-50 years and ASA I and II undergoing elective lower abdominal and pelvic surgery under spinal anesthesia were included in this randomized double-blind study. Patients were randomly divided into 2 groups 25 each; group (I) received intravenous hydrocortisone 100mg every 8 hours for 48 hours and group (II) received intravenous infusion of mannitol 20% 100ml over 30 minutes followed by 100ml every 12hours. Mean (+/- SD) of headache intensity at 0, 6, 12, 24 and 48 hours after beginning of treatment was assessed using visual analog scale.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Study First Submitted: 2016-04-29
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-04
• Status Verified: 2020-08
• Results First Submitted: 2020-08-11
• Results First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Results First Posted: 2020-08-25
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• aged 18-50 years old.
• both sex.
• ASA physical status I and II.
• 70-90 kg body weight.
• height 160-180 cm.
• Elective lower abdominal and pelvic surgery e.g. repair of inguinal hernia, repair of incisional hernia, varicocele and hydrocele.

Exclusion Criteria

• Patients with impaired kidney or liver functions.
• history of cardiac or central nervous system disease.
• uncontrolled medical disease (diabetes mellitus and hypertension)
• history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery
• allergy to the used medications
• patient's refusal
• duration of surgery more than 120 minutes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (I) (N=25)	hydrocortisone 100mg.	Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours (Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT).
Group (II) (N=25)	mannitol 20% intravenous fluid	group (II), received mannitol 20% intravenous fluid (100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis for 48 hours) (Manufactured by Allmed Middle East, Egypt).

Primary Outcome Measures

Name	Time	Method
Number of Patients (in Digits) Got Earlier Relief of PDPH (in Hours) After Use of Hydrocortisone or Mannitol.	within 48 hours after starting of treatment