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Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries .

NCT ID: NCT04783194

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-10-20

Brief Summary

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The purpose of this study is to compare addition of dexamethasone to bupivacaine versus bupivacaine alone for trans-incisional bilateral paravertebral block for postoperative analgesia in elective lumbar spine surgeries.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone + bupivacaine in bilateral TiPVB in lumbar spine surgery

Dexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery for postoperative analgesia

Group Type ACTIVE_COMPARATOR

Dexamethasone+ Bupivacaine

Intervention Type DRUG

Dexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.

Bupivacaine in bilateral TiPVB in lumbar spine surgery

Bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery for postoperative analgesia

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.

Interventions

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Dexamethasone+ Bupivacaine

Dexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.

Intervention Type DRUG

Bupivacaine

Bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* physical status American Society of Anesthesiologists (ASA) I or II.

Exclusion Criteria

* refuse to participate have a body mass index (BMI) \>30 kg/m2 ASA physical status \>II have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological) coagulation abnormalities infection at the injection site tumor in the paravertebral space sepsis Severe chest deformity or scoliosis, due to the possibility of injection into the meninges an allergy or contraindications to the drugs used in the study uncontrolled diabetes patients with active gastric ulceration a history of drug addiction or alcohol abuse a psychiatric illness mental retardation interfering with the evaluation of pain scores.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Amin Mohammed Alansary Amin Ahmed Helwa

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU R 47/2020/2021

Identifier Type: -

Identifier Source: org_study_id