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

• ClinicalTrials.gov Identifier: NCT05788458
• Recruitment Status: Recruiting
• First Posted: March 28, 2023
• Last Update Posted: March 28, 2023
• Sponsor: Benha University
• Information provided by (Responsible Party): Fatma Ahmed Abdel Fatah, Benha University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Perioperative Pain	Drug: Bupivacain	Phase 4

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, we 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Bupivacaine Concentration on Ultrasound Guided Pericapsular Group Nerve Block Efficacy in Hip Surgery Patients: A Randomized Controlled Double Blinded Trial
• Estimated Study Start Date: April 1, 2023
• Estimated Primary Completion Date: August 15, 2023
• Estimated Study Completion Date: September 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. NRS over 24 hours [ Time Frame: 2,4,8,16,24 hours postoperative ]
   From 0 to 10 (0 no pain , 10 very sever pain)
2. Amount of morphine intake. [ Time Frame: 24 hours postoperative ]
   Amount of morphine taken during 24 hours
3. Quality of recovery score (QoR-15) [ Time Frame: at 24 hours postoperative ]

   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).

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Fatma Ah Abdelfatah, MD; 01027011148; drfatmaahmed86@gmail.com

Locations

Egypt

Banha Faculity of Medicine; Recruiting

Banha, Elqalyoubea, Egypt, 13511

Contact: fatma ah abdelfatah, MD 0020102011148 ext 01000607978 drfatmaahmed86@gmail.com

Sponsors and Collaborators

Benha University

Investigators

• Principal Investigator: Fatma Ah Abdelfatah, MD; banha faculity of medicine

More Information

• Responsible Party: Fatma Ahmed Abdel Fatah, lecturer, Benha University
• ClinicalTrials.gov Identifier: NCT05788458
• Other Study ID Numbers: RC 1-3-2023
• First Posted: March 28, 2023
• Last Update Posted: March 28, 2023
• Last Verified: March 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fatma Ahmed Abdel Fatah, Benha University:

pain; positioning; PENG block

Additional relevant MeSH terms:

Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents