PENG Block With Two Diffirent Volume

NCT ID: NCT05358587

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2024-01-04

Brief Summary

Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block is a newly defined block and targets the hip capsule. The aim of this study is to investigate and compare the perioperative analgesic efficacy of PENG blocks applied in two different volumes in patients undergoing hip fracture surgery under spinal anesthesia.

Detailed Description

Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block is a newly defined block and targets the hip capsule. The aim of this study is to investigate and compare the perioperative analgesic efficacy of PENG blocks applied in two different volumes in patients undergoing hip fracture surgery under spinal anesthesia.

60 ASA I-III patients between 35-90 years of age who will be operated for femoral head/neck fractures will be included in the study. US-guided block procedure will be applied 30 minutes before the start of surgery. The patients will be divided into two groups, Group I, PENG block 20ml bupivacaine (n:30) and Group II, PENG block 30ml bupivacaine (n:30) using the closed envelope method in the operating room. Randomization will be performed by one of the researchers for each patient. Randomization information of patients will be used for all follow-up and data collection. The anesthetist applying the block will not take any part in collecting the data or performing the analysis. Numerical rating scale (NRS) will be used to evaluate pain. Patients will be given spinal anesthesia 30 minutes after PENG block. The primary outcome measure was determined as pain during positioning. NRS scores will be recorded after entering the operating room before, immediately before, during, and immediately after any analgesic intervention. Secondary outcome measures will be determined as the time required for LA performance (measured from the start of the position maneuvers to removal of the spinal needle), the quality of the patient position for LA performance ("unsatisfactory", "satisfactory", "good", "very good" to define SA). Questionnary 15 test will be applied to the patients 24 hours after the operation to measure patient satisfaction and to measure patient satisfaction.

Conditions

Pain, Acute; Postoperative Pain; Hip Fractures

Study Design

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

Study Groups

PENG (20 mL)

In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %)

Group Type: EXPERIMENTAL

Ultrasound guided PENG block with 20 mL Local Anesthetic solution

Intervention Type: OTHER

In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %). Block will be performed 30 minutes before spinal anesthesia.

PENG (30 mL)

In this group, US guided PENG block will be performed with 30 ml of Bupivacaine solution (0.25 %)

Group Type: EXPERIMENTAL

Ultrasound guided PENG block with 30 mL Local Anesthetic solution

Intervention Type: OTHER

In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %). Block will be performed 30 minutes before spinal anesthesia.

Interventions

Ultrasound guided PENG block with 20 mL Local Anesthetic solution

In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %). Block will be performed 30 minutes before spinal anesthesia.

Intervention Type: OTHER

Ultrasound guided PENG block with 30 mL Local Anesthetic solution

In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %). Block will be performed 30 minutes before spinal anesthesia.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• contraindications for spinal anesthesia and PENG block
• impaired cognition or dementia
• multiple fractures

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsun University

OTHER

Sponsor Role: lead

Responsible Party

Gamze Ertas

anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gamze Ertas, specialist

Role: PRINCIPAL_INVESTIGATOR

samsun university, samsun training and research hospital

Locations

Samsun University

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Zheng J, Pan D, Zheng B, Ruan X. Preoperative pericapsular nerve group (PENG) block for total hip arthroplasty: a randomized, placebo-controlled trial. Reg Anesth Pain Med. 2022 Mar;47(3):155-160. doi: 10.1136/rapm-2021-103228. Epub 2021 Dec 6.

Reference Type: RESULT

PMID: 34873023 (View on PubMed)

Other Identifiers

PENG_55

Identifier Type: -

Identifier Source: org_study_id