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

NCT ID: NCT04900116

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2022-02-10

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Group 1

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine HCl 0.5 % in 20 ML Injection

Intervention Type: DRUG

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

Group 2

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine HCl 0.25 % in 20 ML Injection

Intervention Type: DRUG

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

Group 3

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine HCl 0.125 % in 20 ML Injection

Intervention Type: DRUG

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

Group 4

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.

Group Type: PLACEBO_COMPARATOR

NaCl 0.9%

Intervention Type: DRUG

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).

Interventions

Bupivacaine HCl 0.5 % in 20 ML Injection

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

Bupivacaine HCl 0.25 % in 20 ML Injection

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

Bupivacaine HCl 0.125 % in 20 ML Injection

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

NaCl 0.9%

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).

Intervention Type: DRUG

Other Intervention Names

Marcaine; Marcaine; Marcaine; Saline Solution

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Nur Canbolat

Principal Investigator, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İlke Akay Akgül, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Locations

Istanbul University

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 21186139 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31998024 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31927234 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31924520 (View on PubMed)

Other Identifiers

2020/1534

Identifier Type: -

Identifier Source: org_study_id