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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06294665
Other study ID # MD113/2023
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 1, 2024
Est. completion date January 1, 2025

Study information

Verified date February 2024
Source Ain Shams University
Contact Mohamed AA Salama
Phone +201006206630
Email m_adel92@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date January 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Total doses of analgesia (Nalbuphine) given to patients in 24 hours postoperatively 9 months
Secondary Occurrence of side effects of drugs. 9 months
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