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PENG Block and Lateral Femoral Cutaneous Nerve Block For Hip Replacement Surgery

Primary Purpose

POSTOPERATIVE ANALGESIA

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
PERICAPSULAR NERVE GROUP BLOCK COMBINED WITH LATERAL FEMORAL CUTANEOUS NERVE BLOCK
Sponsored by
Hanoi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for POSTOPERATIVE ANALGESIA focused on measuring Pericapsular Nerve Group Block, lateral femoral cutaneous nerve, multimodal analgesia, ultrasound-guided analgesia, patient-controlled analgesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-III. Patients had hip replacement surgery. Exclusion Criteria: infection of the anesthetized area. coagulation disorders organs dysfunction allergy to anesthetics did not cooperate with physicians history of opioid dependence inability to participate in the study

Sites / Locations

  • Hanoi Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PENG BLOCK

PCA

Arm Description

receiving pain relief through PENG and LFCN block

receiving morphine PCA analgesia

Outcomes

Primary Outcome Measures

VAS score at rest and on movement
the average VAS score (Visual Analogue Scale) at rest and on movement of both groups. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark.
Side effects
Rate of vomitting/nausea, itchy, urinary retention, respiratory failure postoperative of both groups.

Secondary Outcome Measures

Full Information

First Posted
September 7, 2023
Last Updated
September 14, 2023
Sponsor
Hanoi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06040879
Brief Title
PENG Block and Lateral Femoral Cutaneous Nerve Block For Hip Replacement Surgery
Official Title
Postoperative Analgesia Outcomes Of Pericapsular Nerve Group Block (PENG Block) Combined With Lateral Femoral Cutaneous Nerve Block After Hip Replacement Surgery: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
September 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanoi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: this study aimed to describe the pain relief outcomes after hip replacement surgery by continuous Pericapsular Nerve Group Block (PENG Block) in combination with lateral femoral cutaneous nerve (LFCN) block under the guidance of ultrasound. Methods: patients who had hip surgery at E University hospital, Hanoi, Vietnam from August 2021 to August 2022 belonged to two groups: group of patients with pain relief with PENG block in combination with LFCN block (PENG BLOCK group) and group of patients with patient-controlled intravenous analgesia (PCA group). Outcomes regarding clinical and pain score from initiation of insertion or PCA insertion (H0) to after 72 hours (H72) were recorded.
Detailed Description
First, patients were explained about the study and asked to sign written informed consent if they agreed to participate in the study. Next, the patient was instructed to use the visual analogue scale (VAS) for pain score, as well as how to press the button to request pain relief. Then, a monitor was installed and operated to assess the clinical parameters (electrocardiogram, blood pressure, SpO2, arterial blood pressure, temperature). The patient was oxygenated 3-5 liters/minute and performed a peripheral intravenous line, with an 18G catheter, infused with 0.9% NaCl solution. Spinal anesthesia was administered with ropivacaine 0.5% and fentanyl. During and after the surgery, a group of patients received intravenous morphine analgesia via PCA (concentration 1mg/ml, bolus dose of 1mg, lock time 10 minutes, maximum dose 10mg/4 hours). The remaining group of patients receive pain relief by PENG block and LFCN block. In this group, the ultrasound probe was placed horizontally from the anterior superior iliac spine, and was moved along the femoral arc defining the pubic spine. Then, the transducer was rotated 45 degrees, moved parallel to the femoral arch identifying the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE) and inferior lumbosacral head. The ultrasound probe was moved lightly until the upper end of the femoral head was identified. Next, a 120 mm Tuohy 18G anesthetic needle was used under ultrasound guidance, which was moved lateral to medial in the plane between the ultrasound transducer and the superior tip of the femoral head. Then, 10 mL of ropivacaine 0.25% was injected through the anesthetic needle tip. Data were collected at different times including: before surgery, before anesthesia, during surgery and after surgery. The information was recorded in the medical record. Preoperative data: the collected information included the general characteristics of the study patients including age, gender, weight, height, history of smoking/motion sickness, diagnosis, health classification according to ASA, liver and kidney function tests. With pre-anesthesia data, information was collected including pulse, blood pressure, respiratory rate, SpO2. Intraoperative data: the information collected includes information about anesthesia and surgical procedure. Post-operative data: the collected information includes blood test results (urea, creatinine, liver enzymes), pain score (Visual analogue scale - VAS - scale from 0 to 10, the higher the score, the higher the pain level. more), analgesic drugs consumption status, respiratory and circulatory changes, adverse events, and analgesic satisfaction. Time was recorded from initiation of catheterization or PCA insertion (H0) to after 72 hours (H72).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
POSTOPERATIVE ANALGESIA
Keywords
Pericapsular Nerve Group Block, lateral femoral cutaneous nerve, multimodal analgesia, ultrasound-guided analgesia, patient-controlled analgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
PCA group and PENG BLOCK group
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PENG BLOCK
Arm Type
Experimental
Arm Description
receiving pain relief through PENG and LFCN block
Arm Title
PCA
Arm Type
Active Comparator
Arm Description
receiving morphine PCA analgesia
Intervention Type
Procedure
Intervention Name(s)
PERICAPSULAR NERVE GROUP BLOCK COMBINED WITH LATERAL FEMORAL CUTANEOUS NERVE BLOCK
Intervention Description
During and after the surgery, a group of patients received intravenous morphine analgesia via PCA (concentration 1mg/ml, bolus dose of 1mg, lock time 10 minutes, maximum dose 10mg/4 hours). The remaining group of patients receive pain relief by PENG block and LFCN block. In this group, the ultrasound probe was placed horizontally from the anterior superior iliac spine, and was moved along the femoral arc defining the pubic spine. Then, the transducer was rotated 45 degrees, moved parallel to the femoral arch identifying the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE) and inferior lumbosacral head. The ultrasound probe was moved lightly until the upper end of the femoral head was identified. Next, a 120 mm Tuohy 18G anesthetic needle was used under ultrasound guidance, which was moved lateral to medial in the plane between the ultrasound transducer and the superior tip of the femoral head. Then, 10 mL of ropivacaine 0.25% was injected through the anesthetic needle tip
Primary Outcome Measure Information:
Title
VAS score at rest and on movement
Description
the average VAS score (Visual Analogue Scale) at rest and on movement of both groups. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark.
Time Frame
Time was recorded from initiation of catheterization or PCA insertion (H0) to after 72 hours (H72)
Title
Side effects
Description
Rate of vomitting/nausea, itchy, urinary retention, respiratory failure postoperative of both groups.
Time Frame
Time was recorded from initiation of catheterization or PCA insertion (H0) to after 72 hours (H72)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-III. Patients had hip replacement surgery. Exclusion Criteria: infection of the anesthetized area. coagulation disorders organs dysfunction allergy to anesthetics did not cooperate with physicians history of opioid dependence inability to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tu Nguyen, Professor
Organizational Affiliation
Hanoi Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Hanoi Medical University
City
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We agree that all results and conclusion of this research will be used fully for other researchers
IPD Sharing Time Frame
from September 2023 to the unidentified time
IPD Sharing Access Criteria
anesthesiologists, surgeons all over the world
Citations:
PubMed Identifier
30496081
Citation
Ferguson RJ, Palmer AJ, Taylor A, Porter ML, Malchau H, Glyn-Jones S. Hip replacement. Lancet. 2018 Nov 3;392(10158):1662-1671. doi: 10.1016/S0140-6736(18)31777-X.
Results Reference
result
PubMed Identifier
22461810
Citation
Ferrata P, Carta S, Fortina M, Scipio D, Riva A, Di Giacinto S. Painful hip arthroplasty: definition. Clin Cases Miner Bone Metab. 2011 May;8(2):19-22.
Results Reference
result
PubMed Identifier
22822195
Citation
YaDeau JT, Tedore T, Goytizolo EA, Kim DH, Green DS, Westrick A, Fan R, Rade MC, Ranawat AS, Coleman SH, Kelly BT. Lumbar plexus blockade reduces pain after hip arthroscopy: a prospective randomized controlled trial. Anesth Analg. 2012 Oct;115(4):968-72. doi: 10.1213/ANE.0b013e318265bacd. Epub 2012 Jul 19.
Results Reference
result
PubMed Identifier
19784509
Citation
Duarte LT, Beraldo PS, Saraiva RA. [Effects of epidural analgesia and continuous lumbar plexus block on functional rehabilitation after total hip arthroplasty]. Rev Bras Anestesiol. 2009 Sep-Oct;59(5):531-44. doi: 10.1016/s0034-7094(09)70078-9. Portuguese.
Results Reference
result
PubMed Identifier
16135349
Citation
Singelyn FJ, Ferrant T, Malisse MF, Joris D. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous femoral nerve sheath block on rehabilitation after unilateral total-hip arthroplasty. Reg Anesth Pain Med. 2005 Sep-Oct;30(5):452-7. doi: 10.1016/j.rapm.2005.05.008.
Results Reference
result
PubMed Identifier
33637625
Citation
Lin DY, Morrison C, Brown B, Saies AA, Pawar R, Vermeulen M, Anderson SR, Lee TS, Doornberg J, Kroon HM, Jaarsma RL. Pericapsular nerve group (PENG) block provides improved short-term analgesia compared with the femoral nerve block in hip fracture surgery: a single-center double-blinded randomized comparative trial. Reg Anesth Pain Med. 2021 May;46(5):398-403. doi: 10.1136/rapm-2020-102315. Epub 2021 Feb 26.
Results Reference
result
PubMed Identifier
21526668
Citation
Shafiq F, Hamid M, Samad K. Complications and interventions associated with epidural analgesia for postoperative pain relief in a tertiary care hospital. Middle East J Anaesthesiol. 2010 Oct;20(6):827-32.
Results Reference
result
PubMed Identifier
28656158
Citation
Rasouli MR, Viscusi ER. Adductor Canal Block for Knee Surgeries: An Emerging Analgesic Technique. Arch Bone Jt Surg. 2017 May;5(3):131-132. No abstract available.
Results Reference
result
PubMed Identifier
35096534
Citation
Kamel I, Ahmed MF, Sethi A. Regional anesthesia for orthopedic procedures: What orthopedic surgeons need to know. World J Orthop. 2022 Jan 18;13(1):11-35. doi: 10.5312/wjo.v13.i1.11. eCollection 2022 Jan 18.
Results Reference
result
Links:
URL
https://www.who.int/news-room/fact-sheets/detail/musculoskeletal-conditions
Description
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PENG Block and Lateral Femoral Cutaneous Nerve Block For Hip Replacement Surgery

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