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

Comparison Between Bupivacaine-Dexmedetomidine Versus Bupivacaine-Dexamethasone in Pericapsular Nerve Group (PENG) Block as Post-operative Analgesia in Hip Surgeries.

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

Study Overview

• Status: Recruiting
• Conditions: Hip Fractures; Post Operative Pain
• Intervention / Treatment: Drug: Pericapsular Nerve Group (PENG) Block

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mohamed AA Salama; Phone Number: +201006206630; Email: m_adel92@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11122
    • Recruiting
    • Ain Shams University
    • Contact: Fatma Ebeid; Phone Number: +201095569596; Email: dr.fatma_ebeid@yahoo.com
    • Principal Investigator: Mohamed Salama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A : ( Bupivacaine + Dexmedetomidine ); Group A : will receive bupivacaine 0.25% + dexmedetomidine 1 mic/kg, total volume (20 ml)	Drug: 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.
Active Comparator: Group B: ( Bupivacaine + Dexamethasone ); Group B : will receive bupivacaine 0.25% +dexamethasone (8 mg), total volume(20 ml).	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Total doses of analgesia (Nalbuphine) given to patients in 24 hours postoperatively	9 months
Occurrence of side effects of drugs.	9 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Pain, Postoperative; Hip Fractures
• Other Study ID Numbers: MD113/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No