Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06342102
Other study ID # ID 4286
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 26, 2024
Est. completion date April 30, 2024

Study information

Verified date April 2024
Source Ospedale Edoardo Bassini
Contact Francesco Vetrone, MF
Phone 0039 025799
Email francesco.vetrone@asst-nordmilano.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Total hip arthroplasty is a major surgical procedure performed on a growing number of patients. Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation, thus expediting hospital discharge. Amongst the many peripheral nerve blocks, FIB (fascia iliaca block) has been recommended as the block of choice by many international guidelines since it offers the best pain control with a relatively low risk of motor block. PENG (pericapsular nerve group) and its association with LFCN (lateral femoral cutaneous nerve) has been proposed as an effective alternative that offers comparable, If not better, pain control with a considerably lower risk for motor block compared to FIB. Given the novelty of this block, there are few published papers on the subject, mostly case series or case reports thus justifying the need for retrospective study.


Description:

The primary outcome was the degree of residual quadriceps femoris muscle paresis assessed with the MRC (medical research council) scale at 6 hours between PENG and LCFN. The secondary outcomes were NRS (numeric rating scale) at 6,12, 24 hours, total opioid consumption expressed as milligrams of morphine equivalents (MME), time to first rescue opioid and time to first postoperative ambulation.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date April 30, 2024
Est. primary completion date March 26, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - elective total hip replacement surgery for non-traumatic hip disease, - age over 18 years, - complete clinical chart including type of peripheral nerve block performed, - signed consent form for spinal anesthesia and peripheral nerve block. Exclusion Criteria: - preoperative opioid therapy, - having received a peripheral nerve block other than PENG + LFCN or FICB, - having received general anesthesia, - incomplete chart, - documented muscle weakness - deviation from the established post-operative analgesia protocol.

Study Design


Intervention

Procedure:
PENG + LFCN block
The PENG block was performed under ultrasound guidance. After skin disinfection, the needle was advanced between the psoas tendon and pubic ramus where 20 mL of 0.5% ropivacaine were injected. The LFCN block was performed following the PENG block.10 ml of 0.5% ropivacaine were injected near the nerve into the fat-filled flat tunnel (FFFT) located at the level of the superior anterior iliac spine and lateral to the sartorius muscle.
FIC block
FICB was performed under ultrasound guidance. The needle was advanced above the fascia iliaca and 20 mL of 0.5% ropivacaine were injected

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ospedale Edoardo Bassini

Outcome

Type Measure Description Time frame Safety issue
Other time to first opioid request we studied the effect of Regional anesthesia on opioid-sparing From date of surgery until up to 3 days after
Other time to first postoperative ambulation we studied the effect of Regional anesthesia on opioid-sparing From date of surgery until up to 3 days after
Primary Movement of the lower limb affected by surgery The Medical Research Council (MRC) Muscle Strength Scale (ranging scale from 0 to 5 0= no visible contraction, 5=normal power) was used to assess the degree of residual quadriceps femoris muscle paresis 6 hours postoperatively. 6 hours after surgery
Secondary pain control pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable" 6 hours after surgery
Secondary pain control pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable" 12 hours after surgery
Secondary pain control pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable" 24 hours after surgery
Secondary Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses we studied the effect of Regional anesthesia on opioid-sparing 24 hours after surgery
Secondary Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses we studied the effect of Regional anesthesia on opioid-sparing 6 hours after surgery
Secondary Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses we studied the effect of Regional anesthesia on opioid-sparing 12 hours after surgery
See also
  Status Clinical Trial Phase
Recruiting NCT05944393 - Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery N/A
Recruiting NCT05589246 - Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure N/A
Not yet recruiting NCT03978780 - Erector Spinae Block vs. Placebo Block Study N/A
Terminated NCT02846610 - Registry for Acute Pain Treatment
Completed NCT03679897 - Comparison of 0.375% Ropivacaine and 0.25% Levobupivacaine for Infraclavicular Brachial Plexus Block Phase 4
Recruiting NCT06014749 - Serratus Intercostal Block Versus Epidural Analgesia in Eventration: Prospective Observational Study
Completed NCT04438369 - Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair. N/A
Terminated NCT03500744 - Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery N/A
Completed NCT05160298 - Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy for Cardiac Surgery Phase 2
Recruiting NCT06121726 - Predictive Factors for the Effectiveness of the Ilioinguinal Iliohypogastric Nerve Block for Hernia Surgery
Completed NCT04549090 - Ultrasound Guided Posterior Quadratus Lumborum Block for Postoperative Analgesia in Gynecologic Surgery
Completed NCT05286190 - Caudal Block and Transversus Abdominis Plane Block in Pediatric Inguinal Hernia Repair N/A
Completed NCT02200016 - Displacement of Popliteal Sciatic Nerve Catheters After Major Foot and Ankle Surgery Phase 4
Recruiting NCT06089798 - Analgesic Efficacy of Ultrasound-guided Bilateral Pecto-intercostal Plane Block in Pediatric Cardiac Surgery
Not yet recruiting NCT06115720 - Consent in Anaesthesia N/A
Completed NCT04668183 - Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery
Completed NCT05344105 - Comparison of Postoperative Analgesic Efficacy of Transversalis Fascia Plan Block and Erector Spina Plan Block N/A
Not yet recruiting NCT06313294 - Postoperative Follow-up Via Text Messages Automated Versus Telephone in Patients With Continuous Regional Anesthesia N/A
Completed NCT02950558 - Anesthesia for Pain After Ankle Fracture Surgery Phase 4
Completed NCT05351151 - Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks N/A