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

Sponsor
Benha University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05788458
Collaborator
(none)
90
1
3
6
15.1

Study Details

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
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
Anticipated 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
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Aug 15, 2023
Anticipated Study Completion Date :
Sep 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. [30 minutes after the block]

    From 0 to 10 (0 no pain , 10 very sever pain)

Secondary Outcome Measures

  1. NRS over 24 hours [2,4,8,16,24 hours postoperative]

    From 0 to 10 (0 no pain , 10 very sever pain)

  2. Amount of morphine intake. [24 hours postoperative]

    Amount of morphine taken during 24 hours

  3. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Banha Faculity of Medicine Banha Elqalyoubea Egypt 13511

Sponsors and Collaborators

  • Benha University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatma Ahmed Abdel Fatah, lecturer, Benha University
ClinicalTrials.gov Identifier:
NCT05788458
Other Study ID Numbers:
  • RC 1-3-2023
First Posted:
Mar 28, 2023
Last Update Posted:
Mar 28, 2023
Last Verified:
Mar 1, 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, lecturer, Benha University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 28, 2023