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Intraoperative Retrolaminar Block as Opioid Free Anesthesia After Posterior Lumber Spine Discectomy

NCT ID: NCT05312866

Last Updated: 2022-12-16

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-12-01

Brief Summary

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Opioid-free intraoperative protocols have been successfully used in specific surgical populations with equal or superior results to classic general anesthetic approaches. In instances where opioid-free anesthesia may not be entirely feasible, there exists a continually growing body of evidence that the modern anesthesiologist has a potent pharmacologic and regional anesthetic arsenal that can reduce the amount of opioids required to effectively treat pain.

Retrolaminar block is considered a new, easy and simple technique with decreasing incidence of complications such as hypotension, pleural and nerve injury. Its efficacy had been investigated in trauma patients

Detailed Description

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* Null hypothesis: Intraoperative retrolaminar block will not produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy.
* Alternative hypothesis: Intraoperative retrolaminar block will produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy.

Conditions

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Opioid Free Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Standard analgesia (paracetamol +fentanyl)

Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv

Group Type ACTIVE_COMPARATOR

Standard analgesia (paracetamol +fentanyl)

Intervention Type PROCEDURE

Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv

Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone

Patients will receive intraopertative retrolaminar block: 15 ml of bupivacaine 0. 25 % plus 2ml magnesium sulfate 10% (200mg) plus 2ml (8mg) dexamethasone on each side by slipping the needle of injection on the bone of spinous process and lamina.

Group Type ACTIVE_COMPARATOR

Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone

Intervention Type PROCEDURE

Patients will receive intraopertative retrolaminar block: 15 ml of bupivacaine 0. 25 % plus 2ml magnesium sulfate 10% (200mg) plus 2ml (8mg) dexamethasone on each side by slipping the needle of injection on the bone of spinous process and lamina.

Interventions

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Standard analgesia (paracetamol +fentanyl)

Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv

Intervention Type PROCEDURE

Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone

Patients will receive intraopertative retrolaminar block: 15 ml of bupivacaine 0. 25 % plus 2ml magnesium sulfate 10% (200mg) plus 2ml (8mg) dexamethasone on each side by slipping the needle of injection on the bone of spinous process and lamina.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Written informed consent from the patient.
* Age: 21-60 years old.
* Sex: both sex (males and females).
* American Society of Anesthesiologist Physical status: ASA 1\& II.
* Body Mass Index (BMI) = (25-30 kg/m2).
* Type of operation: elective posterior Lumbar discectomy from L3 to L5 disc space.

Exclusion Criteria

* Altered mental state.
* Patients with known history of allergy to study drugs.
* Advanced hepatic, renal, cardiovascular, and respiratory diseases.
* Patients with chronic pain.
* Patients receiving anticoagulants.
* Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Alshaimaa Abdel Fattah Kamel

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alshaimaa Kamel, M.D

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

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Faculty of Human Medicine, Zagazig University

Zagazig, Alsharquia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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9325

Identifier Type: -

Identifier Source: org_study_id