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Comparison of Local Anesthetic Dose in PENG Block Performed in Total Hip Replacement Operations

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine HCl 0.5 % in 20 ML Injection
Bupivacaine HCl 0.25 % in 20 ML Injection
Bupivacaine HCl 0.125 % in 20 ML Injection
NaCl 0.9%
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring Pericapsuler Nerve Group Block, Regional Anesthesia, Analgesic consumption, Postoperative analgesia, Numeric rating scale

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients scheduled for total hip replacement surgery under regional anesthesia
  • ASA(American Society of Anesthesiology) 1-3
  • Receiving consent that accept regional analgesia

Exclusion Criteria:

  • Refusal of regional anesthesia
  • Infection on the local anesthetic application area
  • Infection in the central nervous system
  • Coagulopathy
  • Increased intracranial pressure (Brain tumors)
  • Known allergy against local anesthetics
  • Anatomical difficulties

Sites / Locations

  • Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

In this group, US guided PENG block will be performed with 20 ml 0.5% bupivacaine using a 22 gauge 10 mm block needle.

In this group, US guided PENG block will be performed with 20 ml 0.25% bupivacaine using a 22 gauge 10 mm block needle.

In this group, US guided PENG block will be performed with 20 ml 0.125% bupivacaine using a 22 gauge 10 mm block needle.

In this group, US guided PENG block will be performed with 20 ml saline solution (%0.9 NaCl) using a 22 gauge 10 mm block needle.

Outcomes

Primary Outcome Measures

Visual Analogue Scale (0-10) pain scores for patients
The VAS (Visual Analog Scale, 0 mm ''no pain'', to 100 mm, ''the worst pain possible'')

Secondary Outcome Measures

Opioid (mg) consumption
Opioid (mg) consumption
Time of onset of narcotic analgesic need
(If VAS > 4, morphine 0.05 mg/kg IV will be administered as rescue analgesia additional analgesia and maximum will be increased to 10 mg.
Incidence of side effects
Incidence of nausea and vomiting
Incidence of quadriceps weakness
Physical examination for lower extremity
Time until postoperative first mobilization
First mobilization time
Length of hospital stay
Hospitalization
Beck depression inventory scores
(1-10 These ups and downs are considered normal, 11-16 Mild mood disturbance, 17-20 Borderline clinical depression, 21-30 Moderate depression, 31-40 Severe depression, Over 40 Extreme depression)
Patient satisfaction
Satisfaction score; 0- very unsatisfied, 3- very satisfied
Surgeon satisfaction
Satisfaction score; 0- very unsatisfied, 3- very satisfied

Full Information

First Posted
April 26, 2021
Last Updated
February 10, 2022
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04900116
Brief Title
Comparison of Local Anesthetic Dose in PENG Block Performed in Total Hip Replacement Operations
Official Title
Comparison of Local Anesthetic Dose in PENG (Pericapsular Nerve Group) Block Performed for Postoperative Analgesia in Total Hip Replacement Operations
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul 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
The investigators research was designed as a single-center, prospective, randomized double-blind study. The patients undergoing total hip replacement surgery in Istanbul University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be included. Patients or persons who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will not be included in the study. Patients will be given US guided PENG blocks using a 22 gauge 10 mm block needle after compliance with the rules of asepsia and antisepsis in the supine position according to the group of patients in which they were included. PENG block will be done for postoperative analgesia. After the PENG block, a single dose of spinal anesthesia will be applied as a regional anesthesia method, in a sitting position, using the appropriate spinal needle, as is routinely applied in the investigators clinic. After the block is completed, the pinprick test will be done and the operation will be started after the successful completion of the block is confirmed. Oxygen will be given to the patients with a face mask at 4 lt / min throughout the operation. ECG, saturation, invasive / noninvasive blood pressure monitoring of the patients will be done. Measurements made at 5-minute intervals will be recorded. In the investigators clinic, the use of PENG block and PCA (patient controlled analgesia) device with intravenous morphine for postoperative analgesia is routinely performed. In this study, four randomized groups will be formed together with the control group. The local anesthetic solution given by the supervisor, whose doses of local anesthetic are predetermined (the investigators and participants do not know the dosage), with a total volume of 20 cc will be used. Local anesthetic agent will not be applied to the control group. As mentioned above, spinal anesthesia will be performed after PENG block and the operation will be started. Pain score and total morphine consumption will be determined by visual pain scoring (VAS) at the postoperative 0, 6, 12, 24 and 48th hours by providing the use of a PCA device with intravenous morphine applied in routine practice to all four groups. As in routine practice, when VAS>4 after each interrogation, morphine 0.05 mg/kg iv will be administered as additional analgesia and the maximum will be increased to 10 mg. Pain management will continue when VAS <4.
Detailed Description
The investigators research was designed as a single-center, prospective, randomized double-blind study. After the approval of the Ethics Committee, the study will start and is aimed to be completed in 12 months. The patients undergoing total hip replacement surgery in Istanbul University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be included. Patients or persons who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will not be included in the study. Patients will be evaluated preoperative before surgery, a detailed history will be taken and physical examination will be carried out. Medical and surgical resume information will be obtained. Patients' Vas scores will be recorded before the operation. Patients will be taken to the operating room after premedication. ECG, pulse oximeter, blood pressure monitoring will be performed in the operating room. Patients will be given US guided PENG blocks using a 22 gauge 10 mm block needle after compliance with the rules of asepsia and antisepsis in the supine position according to the group of patients in which they were included. PENG block will be done for postoperative analgesia. After the PENG block, a single dose of spinal anesthesia will be applied as a regional anesthesia method, in a sitting position, using the appropriate spinal needle, as is routinely applied in the investigators clinic. After the block is completed, the pinprick test will be done and the operation will be started after the successful completion of the block is confirmed. Oxygen will be given to the patients with a face mask at 4 lt / min throughout the operation. ECG, saturation, invasive / noninvasive blood pressure monitoring of the patients will be done. Measurements made at 5-minute intervals will be recorded. In the investigators clinic, the use of PENG block and PCA (patient controlled analgesia) device with intravenous morphine for postoperative analgesia is routinely performed. In this study, four randomized groups will be formed together with the control group. Computer-generated random numbers will be used for simple randomization of patients. The local anesthetic solution given by the supervisor, whose doses of local anesthetic are predetermined (the investigators and participants do not know the dosage), with a total volume of 20 cc will be used. Local anesthetic agent will not be applied to the control group. As mentioned above, spinal anesthesia will be performed after PENG block and the operation will be started. Pain score and total morphine consumption will be determined by visual pain scoring (VAS) at the postoperative 0, 6, 12, 24 and 48th hours by providing the use of a PCA device with intravenous morphine applied in routine practice to all four groups. As in routine practice, when VAS>4 after each interrogation, morphine 0.05 mg/kg iv will be administered as additional analgesia and the maximum will be increased to 10 mg. Pain management will continue when VAS <4. Patients are followed up in the service for 48 hours postoperatively in routine practice. In the postoperative period, patients will be evaluated in terms of additional nausea and vomiting, first mobilization time, hospitalization time, amount of morphine consumed and additional analgesic need, onset time of narcotic analgesic need, preoperative and postoperative in the first month Depression-BECK Score, quadriceps weakness, postop patient satisfaction and surgical satisfaction. During the procedure, complications such as failed block, nerve damage, vascular injury, intravenous injection of local anesthetic, local anesthetic toxicity and allergic reactions will be recorded. Before the study, it was determined that at least 84 patients should be collected in the power analysis performed with the help of similar literature data. After collecting the demographic data and morphine consumption data of the patients, the data will be transferred to the statistical program called SPSS and statistical analysis will be made.The investigators study does not contain any modifications other than the investigators daily routine practices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Pericapsuler Nerve Group Block, Regional Anesthesia, Analgesic consumption, Postoperative analgesia, Numeric rating scale

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
In this group, US guided PENG block will be performed with 20 ml 0.5% bupivacaine using a 22 gauge 10 mm block needle.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
In this group, US guided PENG block will be performed with 20 ml 0.25% bupivacaine using a 22 gauge 10 mm block needle.
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
In this group, US guided PENG block will be performed with 20 ml 0.125% bupivacaine using a 22 gauge 10 mm block needle.
Arm Title
Group 4
Arm Type
Placebo Comparator
Arm Description
In this group, US guided PENG block will be performed with 20 ml saline solution (%0.9 NaCl) using a 22 gauge 10 mm block needle.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine HCl 0.5 % in 20 ML Injection
Other Intervention Name(s)
Marcaine
Intervention Description
In this group, US guided PENG block will be performed with 20 ml 0.5% bupivacaine using a 22 gauge 10 mm block needle.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine HCl 0.25 % in 20 ML Injection
Other Intervention Name(s)
Marcaine
Intervention Description
In this group, US guided PENG block will be performed with 20 ml 0.25% bupivacaine using a 22 gauge 10 mm block needle.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine HCl 0.125 % in 20 ML Injection
Other Intervention Name(s)
Marcaine
Intervention Description
In this group, US guided PENG block will be performed with 20 ml 0.125% bupivacaine using a 22 gauge 10 mm block needle.
Intervention Type
Drug
Intervention Name(s)
NaCl 0.9%
Other Intervention Name(s)
Saline Solution
Intervention Description
In this group, US guided PENG block will be performed with 20 ml %0.9 NaCl solution using a 22 gauge 10 mm block needle (Control Group).
Primary Outcome Measure Information:
Title
Visual Analogue Scale (0-10) pain scores for patients
Description
The VAS (Visual Analog Scale, 0 mm ''no pain'', to 100 mm, ''the worst pain possible'')
Time Frame
Up to 48 hours
Secondary Outcome Measure Information:
Title
Opioid (mg) consumption
Description
Opioid (mg) consumption
Time Frame
during surgery and postoperative period up to 48th hours.
Title
Time of onset of narcotic analgesic need
Description
(If VAS > 4, morphine 0.05 mg/kg IV will be administered as rescue analgesia additional analgesia and maximum will be increased to 10 mg.
Time Frame
during surgery and postoperative period up to 48th hours.
Title
Incidence of side effects
Description
Incidence of nausea and vomiting
Time Frame
during surgery and postoperative period up to 48th hours.
Title
Incidence of quadriceps weakness
Description
Physical examination for lower extremity
Time Frame
postoperative period up to 48th hours and postoperative in the first month
Title
Time until postoperative first mobilization
Description
First mobilization time
Time Frame
Up to 48 hours
Title
Length of hospital stay
Description
Hospitalization
Time Frame
Through study completion, an average of 1 week
Title
Beck depression inventory scores
Description
(1-10 These ups and downs are considered normal, 11-16 Mild mood disturbance, 17-20 Borderline clinical depression, 21-30 Moderate depression, 31-40 Severe depression, Over 40 Extreme depression)
Time Frame
Will be done 3 times 1- on pre-operative hospitalization 2- in the hospital after surgery 3- in the 1st month follow-up after surgery
Title
Patient satisfaction
Description
Satisfaction score; 0- very unsatisfied, 3- very satisfied
Time Frame
postoperative period up to 48th hours and postoperative in the first month
Title
Surgeon satisfaction
Description
Satisfaction score; 0- very unsatisfied, 3- very satisfied
Time Frame
postoperative period up to 48th hours and postoperative in the first month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients scheduled for total hip replacement surgery under regional anesthesia ASA(American Society of Anesthesiology) 1-3 Receiving consent that accept regional analgesia Exclusion Criteria: Refusal of regional anesthesia Infection on the local anesthetic application area Infection in the central nervous system Coagulopathy Increased intracranial pressure (Brain tumors) Known allergy against local anesthetics Anatomical difficulties
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İlke Akay Akgül, MD
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
21186139
Citation
Abdalrahim MS, Majali SA, Stomberg MW, Bergbom I. The effect of postoperative pain management program on improving nurses' knowledge and attitudes toward pain. Nurse Educ Pract. 2011 Jul;11(4):250-5. doi: 10.1016/j.nepr.2010.11.016. Epub 2010 Dec 24.
Results Reference
result
PubMed Identifier
31998024
Citation
Krishna Prasad GV, Khanna S, Jaishree SV. Review of adjuvants to local anesthetics in peripheral nerve blocks: Current and future trends. Saudi J Anaesth. 2020 Jan-Mar;14(1):77-84. doi: 10.4103/sja.SJA_423_19. Epub 2020 Jan 6.
Results Reference
result
PubMed Identifier
31927234
Citation
Bilal B, Oksuz G, Boran OF, Topak D, Dogar F. High volume pericapsular nerve group (PENG) block for acetabular fracture surgery: A new horizon for novel block. J Clin Anesth. 2020 Jun;62:109702. doi: 10.1016/j.jclinane.2020.109702. Epub 2020 Jan 9. No abstract available.
Results Reference
result
PubMed Identifier
31924520
Citation
Aksu C, Cesur S, Kus A. Pericapsular Nerve Group (PENG) block: Controversial points about anatomical differences. J Clin Anesth. 2020 May;61:109701. doi: 10.1016/j.jclinane.2020.109701. Epub 2020 Jan 8. No abstract available.
Results Reference
result

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Comparison of Local Anesthetic Dose in PENG Block Performed in Total Hip Replacement Operations

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