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Management of Post Dural Pucture Headache After Lower Limb Surgeries: Oral Prednisolone vs Oral Pregabalin

Primary Purpose

Analgesia

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Oral prednisolone

oral Pregabalin

caffeine, paracetamol tablet

About this trial

This is an interventional treatment trial for Analgesia focused on measuring oral prednisolone, oral pregabalin, post dural puncture headache (PDPH), lower limb surgeries

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Both gender.
Age: 18- 50 years old.
American Society of Anesthesiologist (ASA) physical status I - II.
Patients are diagnosed as PDPH according to criteria of International Headache Society (IHS) after lower limb surgeries .

Exclusion Criteria:

- Allergy to study drugs.
History of chronic headache and migraine.
History of cerebrovascular accidents and neurological disorders.
Systemic infection
History of uncontrolled DM or hepatic disease or pregnant female
Patient refusal or uncooperative patient.

Sites / Locations

faculty of medicine, Zagazig universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

group A

group B

group C

Arm Description

Group A (conservative treatment): Patients will receive good hydration, recumbent positioning, three tablets per day (combined paracetamol and caffeine tablet) for three days and stool softener.

Group B (oral prednisolone): Patients will receive three tablets per day (one oral tablet prednisolone 20 mg plus two tablets of vitamins to maintain blinding) for three days.

Group C (oral pregabalin): Patients will receive three tablets per day (oral tablet pregabalin 100 mg) for three days.

Outcomes

Primary Outcome Measures

pain intensity of headache

measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)

pain intensity of headache

measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)

pain intensity of headache

measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)

pain intensity of headache

measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)

pain intensity of headache

measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)

Total dose of rescue analgesia (ketorolac) consumption

total consumption of rescue analgesia (ketorolac) from the onset of headache till 72 hours

time of relieve of Post dural puncture headache

time from start treatment till relieve symptoms

Secondary Outcome Measures

The number of participant with nausea, vomiting, diplopia, dizziness and neck stiffness

The number of participant who has symptoms of post dural pucture headache as nausea, vomiting, diplopia, dizziness and neck stiffness

Adverse effects of the study drugs e.g. sedation, blurred vision, sleepiness, and dizziness

In case of sedation, the level will be assessed by using Ramsay Sedation Score (1= anxious or agitated, 2= cooperative and oriented, 3= responds to commands only and 4= brisk response to light tap or loud auditory stimulus)

Full Information

NCT ID

NCT04662125

First Posted

November 28, 2020

Last Updated

April 4, 2021

Sponsor

Zagazig University

1. Study Identification

Unique Protocol Identification Number

NCT04662125

Brief Title

Management of Post Dural Pucture Headache After Lower Limb Surgeries: Oral Prednisolone vs Oral Pregabalin

Official Title

Comparative Study Between Analgesic Effect of Oral Prednisolone and Oral Pregabalin in Management of Post-dural Puncture Headache in Patients Undergoing Lower Limb Surgeries

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 10, 2020 (Actual)

Primary Completion Date

June 10, 2021 (Anticipated)

Study Completion Date

July 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The aim of this study is to compare between oral prednisolone and oral pregabalin in management of PDPH to detect effectiveness of the treatment in reducing severity of PDPH, total rescue analgesic consumption and adverse effects of prednisolone and pregabalin in patients undergoing lower limb surgery.

Detailed Description

To compare between oral prednisolone and oral pregabalin in reducing severity post-dural puncture headache after spinal anesthesia in patients undergoing lower limb surgeries. To calculate total amount of postoperative analgesic requirement for 72 hours after the onset of the headache in all patient groups. To detect any side effects of the study medications in all patient groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Analgesia

Keywords

oral prednisolone, oral pregabalin, post dural puncture headache (PDPH), lower limb surgeries

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Analgesic management of post dural puncture headache: oral prednisolone vs oral pregabalin

Masking

ParticipantOutcomes Assessor

Masking Description

anesthetist not sharing in the study will assess patient

Allocation

Randomized

Enrollment

63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group A

Arm Type

Active Comparator

Arm Description

Group A (conservative treatment): Patients will receive good hydration, recumbent positioning, three tablets per day (combined paracetamol and caffeine tablet) for three days and stool softener.

Arm Title

group B

Arm Type

Active Comparator

Arm Description

Group B (oral prednisolone): Patients will receive three tablets per day (one oral tablet prednisolone 20 mg plus two tablets of vitamins to maintain blinding) for three days.

Arm Title

group C

Arm Type

Active Comparator

Arm Description

Group C (oral pregabalin): Patients will receive three tablets per day (oral tablet pregabalin 100 mg) for three days.

Intervention Type

Drug

Intervention Name(s)

Oral prednisolone

Intervention Description

Patients will receive three tablets per day (one oral tablet prednisolone 20 mg plus two tablets of vitamins to maintain blinding) for three days.

Intervention Type

Drug

Intervention Name(s)

oral Pregabalin

Other Intervention Name(s)

Lyrica

Intervention Description

Patients will receive three tablets per day (oral tablet pregabalin 100 mg) for three days.

Intervention Type

Drug

Intervention Name(s)

caffeine, paracetamol tablet

Intervention Description

Patients will receive good hydration, recumbent positioning, three tablets per day (combined paracetamol and caffeine tablet) for three days and stool softener.

Primary Outcome Measure Information:

Title

pain intensity of headache

Description

measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)

Time Frame

From onset of the headache (0 hour).

Title

pain intensity of headache

Description

measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)

Time Frame

at 12 hours

Title

pain intensity of headache

Description

measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)

Time Frame

at 24 hours

Title

pain intensity of headache

Description

measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)

Time Frame

at 48 hours

Title

pain intensity of headache

Description

measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)

Time Frame

at 72 hours

Title

Total dose of rescue analgesia (ketorolac) consumption

Description

total consumption of rescue analgesia (ketorolac) from the onset of headache till 72 hours

Time Frame

from the onset of headache till 72 hours

Title

time of relieve of Post dural puncture headache

Description

time from start treatment till relieve symptoms

Time Frame

from the onset of headache till 72 hours

Secondary Outcome Measure Information:

Title

The number of participant with nausea, vomiting, diplopia, dizziness and neck stiffness

Description

The number of participant who has symptoms of post dural pucture headache as nausea, vomiting, diplopia, dizziness and neck stiffness

Time Frame

for 72 hours

Title

Adverse effects of the study drugs e.g. sedation, blurred vision, sleepiness, and dizziness

Description

Time Frame

for 72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Both gender. Age: 18- 50 years old. American Society of Anesthesiologist (ASA) physical status I - II. Patients are diagnosed as PDPH according to criteria of International Headache Society (IHS) after lower limb surgeries . Exclusion Criteria: - Allergy to study drugs. History of chronic headache and migraine. History of cerebrovascular accidents and neurological disorders. Systemic infection History of uncontrolled DM or hepatic disease or pregnant female Patient refusal or uncooperative patient.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dina Salem, MD

Phone

01099333513

Ext

002

dinamaghraby@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dina Salem, MD

Organizational Affiliation

faculty of medicine , Zagazig university

Official's Role

Principal Investigator

Facility Information:

Facility Name

faculty of medicine, Zagazig university

City

Zagazig

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dina Salem, MD

Phone

01099333513

Ext

002

dinamaghraby@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

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Management of Post Dural Pucture Headache After Lower Limb Surgeries: Oral Prednisolone vs Oral Pregabalin

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