Effect of Intravenous Versus Intrathecal Dexamethazone on Postdural Puncture Headache
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| ClinicalTrials.gov Identifier: NCT04709029 |
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Recruitment Status :
Not yet recruiting
First Posted : January 14, 2021
Last Update Posted : January 22, 2021
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Sponsor:
Ain Shams University
Information provided by (Responsible Party):
Ashraf Elsayed Elagamy, Ain Shams University
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Brief Summary:
This study will be conducted at Ain Shams University Hospital in Operating Theatre after ethical committe approval number (MS 32/ 2020). It is a prospective randomized controlled study will be done on patients undergoing lower abdominal and lower limb surgeries under spinal anethesia,Eligible patients will be randomized by computer system to one of two groups, either intravenous dexamethazzoe 8 mg with intrathecal heavy bupivacaine 0.5% or intrathecal 4mg dexamethazone with intrathecal heavy bupivacaine 0.5%. .
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postdural Puncture Headache | Drug: Dexamethasone intravenous Drug: Dexamethasone intrathecal | Not Applicable |
Patients will be randomly divided into two equal groups: Group 1: patients receive intrathecal 3 ml bupivacaine 0. 5% +1 ml normal saline + intravenous 8 mg dexamethazone in 10 ml saline. Group 2: patients receive intrathecal 3 ml bupivacaine 0. 5% + 4 mg (1 ml) dexamethazone + intravenous 10 ml normal saline. Upon patients' arrival into the operating room, peripheral oxygen saturation (SPO2), ECG, pulse rate (PR), and systolic and diastolic blood pressures will be monitored one of the researchers and recorded every 5 minutes till the end of surgery. In a sitting position and with antiseptic techniques, 25 G Quincke needle was inserted intrathecally at L3-L4 or L4-L5 interspace through midline approach. The study drugs were given by an anesthesiologist not not aware of the type of medications injected. Subsequently, the patients were put in the supine position, and given oxygen 3 L/minutes by nasal prongs.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 220 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Parallel assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Masking Description: | double (participant and outcome assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Effect of Intravenous Versus Intrathecal Dexamethazone in Bupivacaine Spinal Anesthesia on Postdural Puncture Headache |
| Estimated Study Start Date : | January 20, 2021 |
| Estimated Primary Completion Date : | May 20, 2021 |
| Estimated Study Completion Date : | June 20, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Headache
Drug Information available for:
Dexamethasone
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: intravenous dexamethazone group
Patients receive intrathecal 3 ml heavy bupivacaine 0. 5% +1 ml normal saline + intravenous 8 mg dexamethazone in 10 ml saline,to prevent postdural puncture headache. Spinal anesthesia will be done in a sitting position under complete aseptic techniques, 25 G Quincke needle was inserted intrathecally at L3-L4 or L4-L5 interspace through midline approach. The study drugs were given by an anesthesiologist not aware of the type of medications injected.
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Drug: Dexamethasone intravenous
Evaluation of intravenous dexamethazone in prevention of postdural puncture headache |
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Active Comparator: intrathecal dexamethazone group
Patients receive intrathecal 3 ml heavy bupivacaine 0.5% + 4 mg (1 ml) dexamethazone + intravenous 10 ml normal saline to prevent postdural puncture headache. Spinal anesthesia will be done in a sitting position under complete aseptic techniques, 25 G Quincke needle was inserted intrathecally at L3-L4 or L4-L5 interspace through midline approach. The study drugs were given by an anesthesiologist not aware of the type of medications injected.
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Drug: Dexamethasone intrathecal
Evaluation of intrathecal dexamethazone in prevention of postdural puncture headache |
Primary Outcome Measures :
- Prevention of postdural puncture headache [ Time Frame: 48 hours after spinal anesthesia ]prevention of postdural puncture headache after spinal anesthesia in the first 48 hours postoperatively
Secondary Outcome Measures :
- Duration of sensory block [ Time Frame: 4 hours from injection of drug in subarachnoid space. ]Duration of sensory block after spinal anesthesia from injection of drug till regain of sensation at level of T10
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| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients ASA I or II undergoing lower limb surgeries under spinal anesthesia
- Patients ASAI or II undergoing lower abdominal surgeries under spinal anesthesia.
Exclusion Criteria:
- Emergency surgeries.
- Patients with uncompensated heart diseases.
- Patients with coagulopathy.
- Presence of infection at site of injection of spinal anesthesia.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04709029
Contacts
| Contact: Ashraf Elagamy, E | oo2o224701953 | elagamy_ashraf@yahoo.com | |
| Contact: Dalia Elfawy | 0020100401092 | daliamfawy@yahoo.com |
Locations
| Egypt | |
| Ain Shams University | |
| Cairo, Egypt, 11566 | |
Sponsors and Collaborators
Ain Shams University
| Responsible Party: | Ashraf Elsayed Elagamy, Assisstant professor Anesthesia,Intensive care and pain management, Ain Shams University |
| ClinicalTrials.gov Identifier: | NCT04709029 |
| Other Study ID Numbers: |
FMASU MS 32/2020 |
| First Posted: | January 14, 2021 Key Record Dates |
| Last Update Posted: | January 22, 2021 |
| Last Verified: | January 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Ashraf Elsayed Elagamy, Ain Shams University:
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intravenous dexamethazone intrathecal dexamethazzone |
Additional relevant MeSH terms:
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Post-Dural Puncture Headache Headache Pain Neurologic Manifestations Headache Disorders, Secondary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Dexamethasone Dexamethasone acetate BB 1101 Anti-Inflammatory Agents |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |