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

NCT04900116 | Completed

• 1 other identifier: 2020/1534
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Pericapsuler Nerve Group Block; Regional Anesthesia; Analgesic consumption; Postoperative analgesia; Numeric rating scale

Outcome Measures

Primary Outcomes (1)

• 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'')

  Up to 48 hours

Secondary Outcomes (9)

• Opioid (mg) consumption

  during surgery and postoperative period up to 48th hours.

• Time of onset of narcotic analgesic need

  during surgery and postoperative period up to 48th hours.

• Incidence of side effects

  during surgery and postoperative period up to 48th hours.

• Incidence of quadriceps weakness

  postoperative period up to 48th hours and postoperative in the first month

• Time until postoperative first mobilization

  Up to 48 hours

Study Arms (4)

Group 1

ACTIVE COMPARATOR

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

Drug: Bupivacaine HCl 0.5 % in 20 ML Injection

Group 2

ACTIVE COMPARATOR

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

Drug: Bupivacaine HCl 0.25 % in 20 ML Injection

Group 3

ACTIVE COMPARATOR

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

Drug: Bupivacaine HCl 0.125 % in 20 ML Injection

Group 4

PLACEBO COMPARATOR

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.

Drug: NaCl 0.9%

Interventions

Bupivacaine HCl 0.5 % in 20 ML Injection 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.

Also known as: Marcaine

Group 1

Bupivacaine HCl 0.25 % in 20 ML Injection 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.

Also known as: Marcaine

Group 2

Bupivacaine HCl 0.125 % in 20 ML Injection 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.

Also known as: Marcaine

Group 3

NaCl 0.9% 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).

Also known as: Saline Solution

Group 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 21186139 RESULT

• 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.

  PMID: 31998024 RESULT

• 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.

  PMID: 31927234 RESULT

• 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.

  PMID: 31924520 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Injections; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• İlke Akay Akgül, MD

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D.

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 25, 2021
• Study Start: June 30, 2021
• Primary Completion: January 31, 2022
• Study Completion: February 10, 2022
• Last Updated: February 11, 2022

Record last verified: 2022-02

Locations

TU (1)