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

Phase 4

Completed

• Conditions: Perioperative Pain
• Interventions: Drug: Bupivacain

• Registration Number: NCT05788458
• Lead Sponsor: Benha University

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.

Study Timeline

• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-03-28
• Study Start: 2023-04-01
• Primary Completion: 2023-10-01
• Status Verified: 2023-11
• Study Completion: 2023-11-01
• Last Update Submitted: 2023-11-24
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Bupivacain	will receive 20 ml of 0.25 % bupivacaine
Group B	Bupivacain	will receive 20 ml of 0.375 % bupivacaine.
Group C	Bupivacain	will receive 20 ml of 0.5 % bupivacaine.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
NRS over 24 hours	2,4,8,16,24 hours postoperative	From 0 to 10 (0 no pain , 10 very sever pain)
Quality of recovery score (QoR-15)	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).
Amount of morphine intake.	24 hours postoperative	Amount of morphine taken during 24 hours

Trial Locations

Locations (1)

Banha Faculity of Medicine; 🇪🇬 Banha, Elqalyoubea, Egypt