The Effect of Preoperative Ultrasound-guided Pericapsular Nerve Group Block (PENG) on the Postoperative Analgesia After Total Hip Arthroplasty: Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Time for first request of rescue analgesia
Study Overview
Brief Summary
- This randomized controlled study will be carried out on 60 adult patients undergoing primary total hip replacement in Tanta University Hospitals. All Patients will receive spinal anesthesia with either sham or real US-guided PENG block.
- The primary outcome will be the time to first request for rescue analgesia. The secondary outcome will be the postoperative Numeric Rating Scale (NRS) score and the total morphine consumption (rescue analgesia) in the first 24 h postoperatively.
Detailed Description
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This prospective randomized double-blinded study will be carried out on 60 adult patients admitted to Tanta University Hospitals for 6 months started immediately after approval of the Institutional Ethical Committee.
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A written informed consent will be obtained from each patient. All data of patients will be confidential with secret codes and private files for each patient, all given data will be used for scientific purposes only after an explanation of the purpose of the study to all patients. - Any unexpected risks encountered during the course of the research will be cleared to the patients as well as to the ethical committee on time.
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The primary endpoint is a prolongation of the postoperative analgesia and reduction of the postoperative analgesic consumption. The study will be terminated if local anesthetic toxicity occurs and this will be announced to the participants and to the ethical committee at the time and adequate measures will be taken to resolve and avoid these risks.
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Group allocation will be done by using computer-generated software of randomization introduced into sealed opaque envelope technique. A blinded nurse, who does not participate in the study or data collection, will read the number contained in the envelope and make group assignments. All the nerve blocks will be performed by one anesthesiologist.
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Control Group: (30 patients) will receive sham PENG (just 1mL saline)
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PENG Group: (30 patients) will receive real PENG (20mL of bupivacaine 0.25% plus 0.2mg/ml dexamethasone)
Anesthetic technique:
•Preoperative assessment will be done by: History taking. Clinical examination. Laboratory investigations including complete blood count, bleeding and clotting times, APTT, liver and kidney function tests.
During the pre-anesthetic assessment, all patients will be familiarized with the Numeric Rating Scale (NRS) score.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
- Sham ESP block will be administrated in the control group
- Measurements will be obtained by anesthetists not participating in the study and blinded to its group
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients, aged 21-75 years
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Scheduled to undergo unilateral total hip replacement surgery.
Exclusion Criteria
- •Patient refusal.
- •Known hypersensitivity to local anesthetics.
- •Body mass index > 35 kg /m
- •Uncooperative or psychiatric patients.
- •Infection at the injection site.
- •Coagulation disorder.
- •Major cardiac, renal, or hepatic diseases
Arms & Interventions
Control group
Patients will receive preoperative US-guided will receive sham PENG with an injection of just 1mL saline.
Intervention: Sham PENG block (Procedure)
PENG Group
Patients will receive preoperative US-guided will receive real PENG with an injection of 20mL of bupivacaine 0.25%+ 0.2mg/mL dexamethasone.
Intervention: Real PENG block (Procedure)
Outcomes
Primary Outcomes
Time for first request of rescue analgesia
Time Frame: The first day after surgery
Time to the first call for morphine rescue analgesia.
Secondary Outcomes
- Postoperative morphine consumption(The first day after surgery)
Investigators
Sameh Abdelkhalik Ahmed Ismaiel
Assistant Professor
Tanta University