Comparison Between Bupivacaine-Dexmedetomidine Versus Bupivacaine-Dexamethasone in Pericapsular Nerve Group (PENG) Block

NCT ID: NCT06294665

Last Updated: 2024-03-05

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-01-01

Brief Summary

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The aim of this work is to compare the effectiveness of bupivacaine- dexmedetomidine mixture versus bupivacaine-dexamethasone mixture in PENG Block as Post-operative Analgesia in Hip surgeries

Detailed Description

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Conditions

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Hip Fractures Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A : ( Bupivacaine + Dexmedetomidine )

Group A : will receive bupivacaine 0.25% + dexmedetomidine 1 mic/kg, total volume (20 ml)

Group Type ACTIVE_COMPARATOR

Pericapsular Nerve Group (PENG) Block

Intervention Type DRUG

The PENG block will be performed ,the patient is placed in the supine position , the procedural leg is slightly abducted, the curvilinear low-frequency ultrasound probe will be placed over the line parallel to the inguinal ligament. It will subsequently rotated 45◦ to identify the anterior inferior iliac spine, the iliopubic eminence, and the psoas tendon. A 22-gauge, 80 mm echogenic needle will inserted in an in-plane approach to place the tip in the musculofascial plane between the pubic ramus posteriorly and the psoas tendon anteriorly. Following negative aspiration, by one of the two syringes each one has a serial number corresponding to each group.

Group B: ( Bupivacaine + Dexamethasone )

Group B : will receive bupivacaine 0.25% +dexamethasone (8 mg), total volume(20 ml).

Group Type ACTIVE_COMPARATOR

Pericapsular Nerve Group (PENG) Block

Intervention Type DRUG

The PENG block will be performed ,the patient is placed in the supine position , the procedural leg is slightly abducted, the curvilinear low-frequency ultrasound probe will be placed over the line parallel to the inguinal ligament. It will subsequently rotated 45◦ to identify the anterior inferior iliac spine, the iliopubic eminence, and the psoas tendon. A 22-gauge, 80 mm echogenic needle will inserted in an in-plane approach to place the tip in the musculofascial plane between the pubic ramus posteriorly and the psoas tendon anteriorly. Following negative aspiration, by one of the two syringes each one has a serial number corresponding to each group.

Interventions

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Pericapsular Nerve Group (PENG) Block

The PENG block will be performed ,the patient is placed in the supine position , the procedural leg is slightly abducted, the curvilinear low-frequency ultrasound probe will be placed over the line parallel to the inguinal ligament. It will subsequently rotated 45◦ to identify the anterior inferior iliac spine, the iliopubic eminence, and the psoas tendon. A 22-gauge, 80 mm echogenic needle will inserted in an in-plane approach to place the tip in the musculofascial plane between the pubic ramus posteriorly and the psoas tendon anteriorly. Following negative aspiration, by one of the two syringes each one has a serial number corresponding to each group.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age 18-65 years.
2. Sex: Both sexes.
3. American Society of Anaesthesiologists (ASA) Physical Status Class I and II.
4. Scheduled for hip surgeries under spinal anaesthesia.

Exclusion Criteria

1. Declining to give written informed consent.
2. History of allergy to the medications used in the study.
3. Contraindications to regional anesthesia (including patient refusal, coagulopathy and local infection).
4. Psychiatric disorder.
5. American Society of Anesthesiologists (ASA) Physical Status Class III and IV.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed AA Salama

Role: CONTACT

+201006206630

Facility Contacts

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Fatma Ebeid

Role: primary

+201095569596

Other Identifiers

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MD113/2023

Identifier Type: -

Identifier Source: org_study_id

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