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

NCT06294665 | Recruiting Phase 1

• 1 other identifier: MD113/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Fractures; Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• The time to the first request of analgesia

  The time interval between the onset of the local infiltration done at the end of the operation and the first request to postoperative analgesia.

  9 months

Secondary Outcomes (2)

• Total doses of analgesia (Nalbuphine) given to patients in 24 hours postoperatively

  9 months

• Occurrence of side effects of drugs.

  9 months

Study Arms (2)

Group A : ( Bupivacaine + Dexmedetomidine )

ACTIVE COMPARATOR

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

Drug: Pericapsular Nerve Group (PENG) Block

Group B: ( Bupivacaine + Dexamethasone )

ACTIVE COMPARATOR

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

Drug: Pericapsular Nerve Group (PENG) Block

Interventions

Pericapsular Nerve Group (PENG) Block 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 A : ( Bupivacaine + Dexmedetomidine ); Group B: ( Bupivacaine + Dexamethasone )

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11122, Egypt

RECRUITING

MeSH Terms

Conditions

Hip Fractures; Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Mohamed AA Salama

CONTACT

+201006206630; m_adel92@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 5, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-02

Locations

EG (1)