Evaluation of PENG Block in Terms of Block Time and Postoperative Pain

NCT ID: NCT06132308

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-15
• Study Completion Date: 2024-08-10

Brief Summary

Hip fracture is a common orthopedic emergency in the elderly and causes significant morbidity and is associated with mortality. In most patients, surgical reduction and fixation is the definitive treatment. Effective perioperative analgesia minimizing the need for opioids and related side effects is recommended in this patient population. Therefore, various methods are used. When the investigators look at the literature, for PENG block It is observed that different drug doses (20cc, 30cc, and 40cc) are used. In this study, the investigators planned to investigate the effectiveness of PENG blocks, postoperative analgesia, and side effects.

Detailed Description

Patients in the ASA 1-3 group who had hip surgery with PENG block for any reason will be included in the study. Approximately 60 patients will participate in the study, the number will be finalized as a result of power analysis. The routine algorithm for patients who will undergo hip surgery is spinal or general anesthesia after peripheral block for postoperative analgesia. Before the block, all patients were monitored by standard monitoring and intravenous vascular access was opened. For PENG block, patients are in the supine position is deposited. The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized. In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed. Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and local anesthetic is administered by intermittent aspiration. Although drug doses vary according to the patient and the surgery to be performed in our clinic, %0.25 bupivacaine is used in 20cc, 30cc and 40cc doses. In all patients with block, 30 minutes after the block application, motor and sensory examination is carried out. Sensory block was evaluated by cold stimulus (0 = no cold sensation, 1 = cold sensation severely reduced, 2 = cold sensation slightly decreased, 3 = normal cold sensation). In patients who will undergo hip surgery, due to limited kidney and liver reserves opioids are often used for analgesia. In our clinic, to reduce opioid use in this elderly patient group, preoperative nerve block method is used. Postoperative analgesic needs of the patients will be recorded from the information in the current patient controlled analgesia device. Demographic data of patients, surgical method and duration from the anesthesia form will be followed. Postoperative numerical evaluation scale (NRS-numeric rating scale; 0 = no pain, 10 = excruciating pain) will be recorded. Postoperative pain, muscle strength, block time and nausea-vomiting PACU, 4, 8, 24 hours will be recorded. Postoperative pain treatment satisfaction of patients numerically scale (NRS, 0 = dissatisfied, 10 = extremely satisfied) and postoperative first night sleep quality at 24 hours with NRS (0= could not sleep all night, 10= slept very well) query will be recorded.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

PENG Block with 0.25% bupivacaine (20 cc)

For PENG block, patients are in the supine position is deposited. The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized. In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed. Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and 20cc local anesthetic used in % 0.25 bupivacaine is administered by intermittent aspiration.

Group Type: ACTIVE_COMPARATOR

PENG Block with 0.25% bupivacaine

Intervention Type: PROCEDURE

Peng block was performed.

PENG Block with 0.25% bupivacaine (30 cc)

For PENG block, patients are in the supine position is deposited. The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized. In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed. Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and 30cc local anesthetic used in % 0.25 bupivacaine is administered by intermittent aspiration.

Group Type: EXPERIMENTAL

PENG Block with 0.25% bupivacaine

Intervention Type: PROCEDURE

Peng block was performed.

PENG Block with 0.25% bupivacaine (40 cc)

For PENG block, patients are in the supine position is deposited. The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized. In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed. Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and 40cc local anesthetic used in % 0.25 bupivacaine is administered by intermittent aspiration.

Group Type: EXPERIMENTAL

PENG Block with 0.25% bupivacaine

Intervention Type: PROCEDURE

Peng block was performed.

Interventions

PENG Block with 0.25% bupivacaine

Peng block was performed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients who have undergone hip surgery with PENG block for any reason

Exclusion Criteria

• chronic opioid users
• cognitive disorders
• written consent form haven't get
• history of relevant drug allergy
• infection of the skin at the site of needle puncture area
• coagulopathy

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Savas Altinsoy

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yıldırım Beyazit Training and Research Hospital

Ankara, , Turkey (Türkiye)

university of health siences diskapi yildirim beyazit T&R hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Diskapı-YB-SA-PENG

Identifier Type: -

Identifier Source: org_study_id