Clinical trial NCT04900116: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Pericapsuler Nerve Group Block
Regional Anesthesia
Analgesic consumption
Postoperative analgesia
Numeric rating scale
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Visual Analogue Scale (0-10) pain scores for patients
timeFrame: Up to 48 hours
Secondary outcomes:
measure: Opioid (mg) consumption
timeFrame: during surgery and postoperative period up to 48th hours.
measure: Time of onset of narcotic analgesic need
timeFrame: during surgery and postoperative period up to 48th hours.
measure: Incidence of side effects
timeFrame: during surgery and postoperative period up to 48th hours.
measure: Incidence of quadriceps weakness
timeFrame: postoperative period up to 48th hours and postoperative in the first month
measure: Time until postoperative first mobilization
timeFrame: Up to 48 hours
measure: Length of hospital stay
timeFrame: Through study completion, an average of 1 week
measure: Beck depression inventory scores
timeFrame: 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
measure: Patient satisfaction
timeFrame: postoperative period up to 48th hours and postoperative in the first month
measure: Surgeon satisfaction
timeFrame: postoperative period up to 48th hours and postoperative in the first month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
state: Fatih
Study officials:
affiliation: Istanbul University
name: İlke Akay Akgül, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.