Ultrasound-guided PENG Block in Total Hip Replacement
Primary Purpose
Pain, Postoperative, Opioid Overdose
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sham PENG block
Real PENG block
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative focused on measuring Hip arthroplasty, Pericapsular nerve block, Pain
Eligibility Criteria
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 /m2.
- Uncooperative or psychiatric patients.
- Infection at the injection site.
- Coagulation disorder.
- Major cardiac, renal, or hepatic diseases
Sites / Locations
- Tanta University
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Control group
PENG Group
Arm Description
Patients will receive preoperative US-guided will receive sham PENG with an injection of just 1mL saline.
Patients will receive preoperative US-guided will receive real PENG with an injection of 20mL of bupivacaine 0.25%+ 0.2mg/mL dexamethasone.
Outcomes
Primary Outcome Measures
Time for first request of rescue analgesia
Time to the first call for morphine rescue analgesia.
Secondary Outcome Measures
Postoperative morphine consumption
Total morphine consumption (rescue analgesia) in the first day postoperatively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04984109
Brief Title
Ultrasound-guided PENG Block in Total Hip Replacement
Official Title
The Effect of Preoperative Ultrasound-guided Pericapsular Nerve Group Block (PENG) on the Postoperative Analgesia After Total Hip Arthroplasty: Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
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.
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.
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.
Control Group: (30 patients) will receive sham PENG (just 1mL saline)
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.
In the holding area, After the establishment of intravascular access by introducing an 18-gauge intravenous (IV) cannula, all the patients will be preloaded with Ringer's lactate solution (7 mL/kg).
On arrival at operation room, Routine monitoring of heart rate by ECG, noninvasive blood pressure (NIBP), pulse oximetry will be done.
Lumbar puncture will be performed at the level of L3-L4/L4-L5 intervertebral space with a 25-gauge spinal needle. After ensuring free flow of cerebrospinal fluid, 2 mL of hyperbaric bupivacaine solution (0.5%) (10mg)) with 0.5 mL (25 µg) fentanyl will be injected. The sensory block will be assessed by loss of sensation to pinprick test. The level of the sensory block should achieve at least a level of T10. Moreover, the motor block will be assessed by modified Bromage score till reaching at least a score of 2. (0; means the ability of the patient to move the hip, knee, and ankle, 1; means the inability of the patient to move the hip, but can move the knee and ankle, 2; means the inability of the patient to move the hip and knee, but can move the ankle, and finally 3; means the inability of the patient to move the hip, knee, and ankle). If the sensory and motor block levels will not be achieved within 20 minutes, the patient will be excluded from the study and receive general anesthesia. If the sensory and motor block will be achieved, the patient will receive an ultrasound-guided PENG block before starting the surgery.
ThePENG block will be performed with the patient in the supine position in the operative area with adequate groin exposure. The probe will first be placed at the anterior superior iliac spine in the transverse plane, and then will be moved caudally to identify the anterior inferior iliac spine (AIIS). The probe will be then rotated to align the AIIS and iliopubic eminence (IPE). This will reveal the iliopsoas tendon and muscle together with femoral vessels superficially. A 22-G 100-mm echogenic needle will be inserted in-plane from lateral to medial, and the tip will be kept at the midpoint of AIIS and IPE deep to psoas tendon. After lifting of the psoas tendon by hydrolocation, the patients in the PENG group will receive 20 ml of (0.25%) bupivacaine with 0.2 mg/ml dexamethasone that will be injected in 5 ml aliquots after negative aspiration.The control group will receive 1 mL of normal saline.
After completion of the surgical procedure, a patient will be transferred to Post-Anesthesia Care Unit (PACU). Paracetamol 15 mg/kg IV will be administered every 6 hours after discharge to the ward.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Opioid Overdose
Keywords
Hip arthroplasty, Pericapsular nerve block, Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective study
Masking
ParticipantInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Patients will receive preoperative US-guided will receive sham PENG with an injection of just 1mL saline.
Arm Title
PENG Group
Arm Type
Experimental
Arm Description
Patients will receive preoperative US-guided will receive real PENG with an injection of 20mL of bupivacaine 0.25%+ 0.2mg/mL dexamethasone.
Intervention Type
Procedure
Intervention Name(s)
Sham PENG block
Intervention Description
The regional block will be performed with the patient in the supine position in operative area with adequate groin exposure. The probe will first be placed at the anterior superior iliac spine in transverse plane, and then will be moved caudally to identify anterior inferior iliac spine (AIIS). The probe will be then rotated to align the AIIS and iliopubic eminence (IPE). This will reveal the iliopsoas tendon and muscle together with femoral vessels superficially. A 22-G 100-mm echogenic needle will be inserted in-plane from lateral to medial, and the tip will be kept at the midpoint of AIIS and IPE deep to psoas tendon. After lifting of psoas tendon by hydrolocation, the patients in PENG group will receive 1 mL of normal saline.
Intervention Type
Procedure
Intervention Name(s)
Real PENG block
Intervention Description
The regional block will be performed with the patient in the supine position in operative area with adequate groin exposure. The probe will first be placed at the anterior superior iliac spine in transverse plane, and then will be moved caudally to identify anterior inferior iliac spine (AIIS). The probe will be then rotated to align the AIIS and iliopubic eminence (IPE). This will reveal the iliopsoas tendon and muscle together with femoral vessels superficially. A 22-G 100-mm echogenic needle will be inserted in-plane from lateral to medial, and the tip will be kept at the midpoint of AIIS and IPE deep to psoas tendon. After lifting of psoas tendon by hydrolocation, the patients in PENG group will receive 20 ml of (0.25%) bupivacaine with 0.2 mg/mL dexamethasone that will be injected in 5 ml aliquots after negative aspiration.
Primary Outcome Measure Information:
Title
Time for first request of rescue analgesia
Description
Time to the first call for morphine rescue analgesia.
Time Frame
The first day after surgery
Secondary Outcome Measure Information:
Title
Postoperative morphine consumption
Description
Total morphine consumption (rescue analgesia) in the first day postoperatively.
Time Frame
The first day after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 /m2.
Uncooperative or psychiatric patients.
Infection at the injection site.
Coagulation disorder.
Major cardiac, renal, or hepatic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh Abdelkhalik, M.D
Organizational Affiliation
Assistant Professor of Anesthesia and Intensive Care, Tanta University
Official's Role
Study Director
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
Algharbia
ZIP/Postal Code
31511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Once the study had been successfully completed, the data will be shared with other researchers.
IPD Sharing Time Frame
- Within 6 months from acceptance of publication
IPD Sharing Access Criteria
samehabdelkhalik1982@gmail.com
Learn more about this trial
Ultrasound-guided PENG Block in Total Hip Replacement
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