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

Effect of Bupivacaine Concentration on Ultrasound Guided Pericapsular Group Nerve Block Efficacy in Hip Surgery Patients: A Randomized Controlled Double Blinded Trial

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).

Study Overview

• Status: Completed
• Conditions: Perioperative Pain
• Intervention / Treatment: Drug: Bupivacain

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.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Elqalyoubea
    • Banha, Elqalyoubea, Egypt, 13511
      • Banha Faculity of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; will receive 20 ml of 0.25 % bupivacaine	Drug: 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.
Active Comparator: Group B; will receive 20 ml of 0.375 % bupivacaine.	Drug: 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.
Active Comparator: Group C; will receive 20 ml of 0.5 % bupivacaine.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS at rest and on passive 15° limb lifting, EOSP.	From 0 to 10 (0 no pain , 10 very sever pain)	30 minutes after the block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS over 24 hours	From 0 to 10 (0 no pain , 10 very sever pain)	2,4,8,16,24 hours postoperative
Amount of morphine intake.	Amount of morphine taken during 24 hours	24 hours postoperative
Quality of recovery score (QoR-15)	This questionnaire covers a total of 15 questions under five clinical dimensions of health; physical comfort (five-item), emotional status (four-item), psychological support (two-item), physical independence (two-item) and pain (twoitem). a numerical rating scale of 11 point for each question leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).	at 24 hours postoperative

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Fatma Ah Abdelfatah, MD, Banha Faculity of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: pain; PENG block; positioning
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: RC 1-3-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No