Volume Dependent Effect of Pericapsular Nerve Block

Post Operative Pain Clinical Trial

Official title:

Comparison of the Volume Dependent Effect of Pericapsular Nerve Block in Patients Operated for Femur Fracture: A Randomized Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05256056
• Other study ID #: 2021/516
• Status: Completed
• Phase: N/A
• Start date: February 25, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In PENG block technique, the local anesthetic agent is injected between the psoas tendon and the pubic ramus to block the sensory branches of the nerves which innervates the hip capsule for providing analgesia without causing muscle weakness. Since the PENG block is a facial plane block, it causes a volume dependent distribution. There are a few case reposts and cadaveric studies on volume dependent effect of analgesia and motor weakness of PENG block.

In our study, we aimed to evaluate the clinical effects of the volume-dependent efficacy of PENG block.

Description:

Femur fracture is the one of the most common case groups and it is seen mostly in the elderly patient population with comorbidities. For these patients, perioperative, postoperative analgesia and early mobilization are important to reduce cardiopulmonary complications and morbidity. Femoral fracture operations are mostly performed under spinal anesthesia especially under unilateral spinal anesthesia to sustain more stable hemodynamics. The lateral decubitus position, which is used for unilateral spinal anesthesia, is a painful position for these patients. Intravenous opioids are used for this procedure, however they have possible side-effects, such as sedation, inhibition of respiratory, lower blood pressure. Because of these reasons, pericapsular nerve block (PENG) has been applied recently to avoid complications. By using PENG block , positioning for spinal anesthesia is easier for patients and anesthesiologists, and postoperative analgesia can be provided.

By PENG block, the local anesthetic agent is injected between the psoas tendon and the pubic ramus to block the sensory branches of the nerves innervating the hip capsule, thus providing analgesia in patients, but muscle weakness is not expected. Becacuse PENG block is a facial plane block, it shows a volume dependent distribution. There are a few case reposts and cadaveric studies, which are showing volume depend effect of analgesia and motor weakness of PENG block.

In our study, we aimed to evaluate the clinical effects of the volume-dependent efficacy of PENG block.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who will undergoing hip arthroplasty surgery

• Patients over the age of 18

• ASA I-II-III patients

• Patients who will be operated under spinal anesthesia

Exclusion Criteria:

• ASA IV patients, Pregnant women

• Patients who are not suitable for spinal anesthesia

• Patients diagnosed with Alzheimer's and dementia who cannot cooperate

• Patients who are not suitable for peripheral nerve block (patients with infection in the injection area, with local anesthetic allergy, with coagulopathy)

• Patients who do not want to participate in the study

• Patients under the age of 18

• Patients switched to general anesthesia

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone
• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Bupivacain
efficacy of bupivacaine in different volumes

Locations

Country	Name	City	State
Turkey	Sisli Etfal Research and Training Hospital	Seyrantepe	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Pascarella G, Costa F, Del Buono R, Pulitanò R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agrò FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1. — View Citation

Sandri M, Blasi A, De Blasi RA. PENG block and LIA as a possible anesthesia technique for total hip arthroplasty. J Anesth. 2020 Jun;34(3):472-475. doi: 10.1007/s00540-020-02768-w. Epub 2020 Mar 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analouge scale	the VAS 0 means no pain, 10 means the worst pain possible	up to 24 hours,
Primary	pin-prick test	the ability to determine the difference between sharp and dull.	up to 20 minutes
Secondary	cold sensation test	feel the cold: 0, not feel : 1	up to 20 minutes
Secondary	presence of quadriceps motor block	Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).	up to 24 hours