Effect of Bupivacaine Concentration on Ultrasound Guided Pericapsular Group Nerve Block Efficacy in Hip Surgery Patients

NCT ID: NCT05788458

Last Updated: 2023-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2023-11-01

Brief Summary

Fractures in and around the hip are quite common irrespective of both the young and elderly population groups and are associated with extreme pain.The anterior hip capsule is innervated by articular branches of femoral nerve, obturator nerve and accessory obturator nerve (AON) as reported by previous anatomic studies, suggesting that these nerves should be the main targets for hip analgesia, which can be blocked by Peri-capsular nerve group (PENG).

Detailed Description

Fractures in and around the hip are quite common irrespective of both the young and elderly population groups and are associated with extreme pain. A hip fracture is a serious injury, with complications that can be life-threatening and is a common orthopedic emergency in the elderly. Early surgery within 48 h of fracture has shown to decrease the complication and mortality rates.

Spinal anaesthesia is the most common mode of anaesthesia used to fix these fractures. Extreme pain due to fracture does not allow ideal positioning for these procedures. and hence a problem to access the subarachnoid space. Inadequate postoperative analgesia can restrict the limb mobility thereby delaying recovery along with increased consumption of opioids.

Effective perioperative analgesia that reduces the requirement of opioids and its adverse effects is essential in this population.

The anterior hip capsule is innervated by articular branches of femoral nerve, obturator nerve and accessory obturator nerve (AON) as reported by previous anatomic studies, suggesting that these nerves should be the main targets for hip analgesia, which can be blocked by Peri-capsular nerve group (PENG) .

PNB with lower volume and higher concentration of local anesthetic was more efficacious than higher volumes and lower concentrations of local anesthetic of equivalent dose.

Using this information, the investigators will conduct this study to evaluate the efficacy of bupivacaine at three different concentration and doses in equivalent volume used in ultrasound guided PENG block for positioning & post-operative analgesia.

Conditions

Perioperative Pain

Study Design

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

Study Groups

Group A

will receive 20 ml of 0.25 % bupivacaine

Group Type: ACTIVE_COMPARATOR

Bupivacain

Intervention Type: DRUG

The blocks will be performed in supine position under complete aseptic condition. The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") will be initially placed in a transverse plane over the anterior superior iliac spine (ASIS) and then alignes to identify the following landmarks: Anterior inferior iliac spine, ilio-pubic eminence, iliopsoas muscle and tendon, the femoral artery, and Pectineus muscle. Point of injection will be musculo-fascial plane between the psoas tendon and ilio-pubic eminence.

Group B

will receive 20 ml of 0.375 % bupivacaine.

Group Type: ACTIVE_COMPARATOR

Bupivacain

Intervention Type: DRUG

The blocks will be performed in supine position under complete aseptic condition. The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") will be initially placed in a transverse plane over the anterior superior iliac spine (ASIS) and then alignes to identify the following landmarks: Anterior inferior iliac spine, ilio-pubic eminence, iliopsoas muscle and tendon, the femoral artery, and Pectineus muscle. Point of injection will be musculo-fascial plane between the psoas tendon and ilio-pubic eminence.

Group C

will receive 20 ml of 0.5 % bupivacaine.

Group Type: ACTIVE_COMPARATOR

Bupivacain

Intervention Type: DRUG

The blocks will be performed in supine position under complete aseptic condition. The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") will be initially placed in a transverse plane over the anterior superior iliac spine (ASIS) and then alignes to identify the following landmarks: Anterior inferior iliac spine, ilio-pubic eminence, iliopsoas muscle and tendon, the femoral artery, and Pectineus muscle. Point of injection will be musculo-fascial plane between the psoas tendon and ilio-pubic eminence.

Interventions

Bupivacain

The blocks will be performed in supine position under complete aseptic condition. The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") will be initially placed in a transverse plane over the anterior superior iliac spine (ASIS) and then alignes to identify the following landmarks: Anterior inferior iliac spine, ilio-pubic eminence, iliopsoas muscle and tendon, the femoral artery, and Pectineus muscle. Point of injection will be musculo-fascial plane between the psoas tendon and ilio-pubic eminence.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• (ASA )classes I and II
• patients of either sex
• above the age of 18 who will undergo hip surgeries( (Dynamic hip screw fixation or hemiarthroplasty)(not older than 2 weeks) with persistent pain and scheduled for surgery under SA with an expected duration of 2.5 hours).

Exclusion Criteria

• patient's refusal to participate
• any contraindications to SA or peripheral nerve blocks
• history of ischemic heart disease
• patients on opioids for chronic pain
• patients with significant cognitive impairment.
• Patients who have surgery on the hip or spine within 3 months or have no pain while sitting by themselves (resting pain less than 4 on NRS) for SA without any support

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Ahmed Abdel Fatah

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatma Ah Abdelfatah, MD

Role: PRINCIPAL_INVESTIGATOR

banha faculity of medicine

Locations

Banha Faculity of Medicine

Banhā, Elqalyoubea, Egypt

Countries

Egypt

References

Abdelfatah FA, Elhadad MA. Effect of bupivacaine concentration on ultrasound-guided pericapsular group nerve block efficacy in hip surgery patients: comparative, randomized, double-blinded clinical trial. Br J Pain. 2024 Oct;18(5):425-432. doi: 10.1177/20494637241262516. Epub 2024 Jun 14.

Reference Type: DERIVED

PMID: 39355572 (View on PubMed)

Other Identifiers

RC 1-3-2023

Identifier Type: -

Identifier Source: org_study_id