Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06166602
Other study ID # 2023/0455
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 20, 2023
Est. completion date December 20, 2023

Study information

Verified date December 2023
Source Istanbul Medeniyet University
Contact Gokce Alis, MD
Phone +905368265875
Email alisgokce@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Postoperative pain management has an important place in anesthesia practices. In order to ensure patient comfort after the surgery, to start postoperative rehabilitation early, and to prevent the process from causing mood disorders such as anxiety and pathological conditions such as chronic pain syndrome, the pain caused by the operation in the postoperative period must be effectively relieved. Pericapsular nerve group (PENG) block; It is a regional anesthesia technique that targets the anterior capsule of the hip joint and aims to block the joint branches of the accessory obturator nerve and femoral nerve by administering local anesthetic. Although it has been described recently, controlled prospective studies in the literature have shown it to be a safe and effective regional technique for postoperative pain after hip surgery. However, volume studies on this block are limited. Therefore, in this study, we aimed to determine the optimal dose by comparing the effectiveness of PENG block on pain using different local anesthetic volumes.


Description:

Postoperative pain management has an important place in anesthesia practices. In order to ensure patient comfort after the surgery, to start postoperative rehabilitation early, and to prevent the process from causing mood disorders such as anxiety and pathological conditions such as chronic pain syndrome, the pain caused by the operation in the postoperative period must be effectively relieved. Pericapsular nerve group (PENG) block; It is a regional anesthesia technique that targets the anterior capsule of the hip joint and aims to block the joint branches of the accessory obturator nerve and femoral nerve by administering local anesthetic. Although it has been described recently, controlled prospective studies in the literature have shown it to be a safe and effective regional technique for postoperative pain after hip surgery. However, volume studies on this block are limited. Therefore, in this study, we aimed to determine the optimal dose by comparing the effectiveness of PENG block on pain using different local anesthetic volumes It was planned to be performed with patients who had hip replacement surgery and patients who are included in the study after obtaining the necessary consents will be randomly assigned to one of Group I or Group II by sealed envelope method. Patients taken to the operating room will receive standard monitoring such as ECG, peripheral oxygen saturation and noninvasive blood pressure monitoring. Midazolam 1 mg IV, fentanyl 1 mcg/kg IV, propofol 1.5-2 mg/kg IV and rocuronium 0.6 mg/kg IV. After routine anesthesia induction, the patient will be intubated with the appropriate intubation tube. Anesthesia maintenance will be provided with 0.8 MAC sevoflurane and remifentanil infusion, as we apply in our routine. Ventilator parameters will be regulated as FiO2 50%, Vt: 0.8 ml/kg, and respiratory frequency 10-14/min, so that EtCO2 is in the range of 25-40 mmHg. Near the end of the operation, our routine analgesic application is 0.1mg/kg IV Morphine will be administered. After the operation is completed, the pericapsular nerve group block will be performed by entering the patient's suprainguinal area with a 100 mm block needle under ultrasound guidance, as in the standard practice of our clinic, and local anesthetic will be administered to the area between the psoas muscle tendon and the hip joint. During the procedure, ultrasound will be used to determine the location and visualize the distribution of the administered drug. The administered drug volume was planned to be 20 cc of 0.25% bupivacaine for group I patients and 10cc of 0.25% bupivacaine for group II patients (their concentrations would be the same but their volumes would be different). Then, the patient will be awakened from anesthesia; Patients with adequate respiratory effort below sevoflurane 0.2 MAC should receive atropine 0.1 mg/kg and neostigmine 0.05 mg/kg IV, which we routinely use, will be applied and extubated. Postoperative 30th minute, 4th hour, 6th hour, 12th hour, 24th hour pain intensities of the patients were evaluated using NRS (Numerical rating Scale) score (0-10) and postoperative Nausea and Vomiting Descriptive Scale (0 = none, 1 = mild nausea, 2 = nausea, 3 = vomiting once, 4 = vomiting more than once) will be evaluated and recorded. At the end of the surgery, patients will be given IV Morphine PCA (patient controlled analgesia) with a 2 ml bolus at a concentration of 0.5 mg/cc for 15 minutes and the amount of Morphine used during the hours when the patient's NRS score is recorded will be recorded. The patients' mobilization time after the operation will be recorded. 0.15 mg/kg IV Ondansetron will be administered for patients with Postoperative Nausea and Vomiting Descriptive Scale 2 and above. 24 hours after the surgery, patient satisfaction will be evaluated and recorded on a Likert Satisfaction scale (1-5).


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 20, 2023
Est. primary completion date December 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Patients with informed consent 2. Patients planned for hip surgery 3. Those between the ages of 18-80 4. ASA (American Society of Anesthesiologists) I-III patients Exclusion Criteria: 1. Patients who do not give consent 2. Patients with coagulopathy 3. Patients with a history of local anesthetic drug allergy and toxicity 4. Patients with advanced organ failure 5. Patients with mental retardation 6. Patients with infection at the injection site 7. Pediatric patients and patients over 80 years of age 8. Pregnant patients will not be included in the study.

Study Design


Intervention

Drug:
PENG block with 0.25% bupivacaine.
Peng block will be applied to the same side as the surgery, using 0.25% bupivacaine at the same concentration in different volumes.

Locations

Country Name City State
Turkey Istanbul Medeniyet University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Choi YS, Park KK, Lee B, Nam WS, Kim DH. Pericapsular Nerve Group (PENG) Block versus Supra-Inguinal Fascia Iliaca Compartment Block for Total Hip Arthroplasty: A Randomized Clinical Trial. J Pers Med. 2022 Mar 6;12(3):408. doi: 10.3390/jpm12030408. — View Citation

Lin DY, Brown B, Morrison C, Fraser NS, Chooi CSL, Cehic MG, McLeod DH, Henningsen MD, Sladojevic N, Kroon HM, Jaarsma RL. The Pericapsular Nerve Group (PENG) block combined with Local Infiltration Analgesia (LIA) compared to placebo and LIA in hip arthroplasty surgery: a multi-center double-blinded randomized-controlled trial. BMC Anesthesiol. 2022 Aug 6;22(1):252. doi: 10.1186/s12871-022-01787-2. — View Citation

Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Rating Scale Score Numeric Rating Scale Score (0: No pain, 10: Worst pain imaginable) Up to 24 hours
Secondary Postoperative Opioid Consumption 24 hour morphine consumption on PCA device Up to 24 hours
Secondary Postoperative Nausea and Vomiting Postoperative Nausea and Vomiting Scale (0: no PONV, 1: mild nausea, 2: severe nausea, 3: vomiting once in 24 hours, 4: Vomiting more than once in 24 hours) Up to 24 hours
Secondary Patient satisfaction Likert scale (1-5, 1: very unsatisfied, 2: unsatisfied, 3: neutral, 4: satisfied, 5: very satisfied) Up to 24 hours
See also
  Status Clinical Trial Phase
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT03181620 - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Recruiting NCT06007378 - Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery N/A
Recruiting NCT05943015 - Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks N/A
Completed NCT04544228 - Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy N/A
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT03663478 - Continuous TQL Block for Elective Cesarean Section Phase 4
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Completed NCT05170477 - Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment N/A
Not yet recruiting NCT04561856 - Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone Phase 4
Completed NCT06425601 - A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy N/A
Completed NCT03612947 - TAP Block in Laparoscopic Cholecystectomy. Phase 2
Completed NCT05974501 - Pre vs Post Block in Total Knee Arthroplasty (TKA) Phase 4
Completed NCT05995912 - Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain Phase 2
Completed NCT04571515 - Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain Phase 2
Active, not recruiting NCT04190355 - The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain N/A
Recruiting NCT05145153 - Incidence of Chronic Pain After Thoracic Surgery
Recruiting NCT03697278 - Monitoring Postoperative Patient-controlled Analgesia (PCA) N/A