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Status unknownNCT05528822Updated Feb 6, 2023

Study of H-FICB & PENG Block in Elderly Patients' THA on the Post-operative Quality of Recovery

An interventional study of ultrasound-guided high fascia iliaca compartment block and ultrasound-guided pericapsular nerve group (PENG) block in Nerve Block and Quality of Recovery, sponsored by Affiliated Hospital of Nantong University. Status unknown at 1 site in China. Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-06.

Sponsored by Affiliated Hospital of Nantong University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
65 Years to 80 Years
Sex
All
01

Study summary

Total joint replacement is projected to become the most common elective surgical procedure in the coming decade; the prevalence of total hip arthroplasty (THA) was estimated as more than 2.5 million individuals in the entire United States population. Orthopedic procedures involving the hip have remained challenging for regional anesthesia given the complex innervation, painful nature contributing to difficulty positioning, and a desire to maintain mobility to hasten postoperative recovery.

Read the detailed description

By comparing the intraoperative and postoperative rehabilitation indexes of high fascia iliac nerve block and hip pericapsular nerve block, we can choose a more suitable analgesic method for this operation.

02

Conditions studied

  • Nerve Block
  • Quality of Recovery

Keywords

  • modified fascia iliaca compartment block
  • pericapsular nerve group block
  • the post-operative quality of recovery
  • HHS score
  • VAS score
03

In context

Lead sponsor

Affiliated Hospital of Nantong University is the lead sponsor of 92 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged 65 to 80 years male and female
  • Scheduled for elective single-incision laparoscopic cholecystectomy
  • The patients volunteered to participate in the study and signed the informed consent

Exclusion criteria

Exclusion Criteria:

  • Preexisting neuropathy
  • Coagulopathy
  • Local skin infection
  • Hepatic, renal or cardiorespiratory failure
  • Local anesthetic allergy
  • Pregnancy
  • Complications of gallstone with gallbladder perforation
  • Diffuse peritonitis
  • Acute pyogenic cholangitis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Group F: H-FICB under ultrasound guidance before general anesthesia

    Group F was subjected to a high fascia iliaca compartment block under ultrasound guidance before general anesthesia.

    Procedure: ultrasound-guided high fascia iliaca compartment block

  • Experimental
    Group P: PENG block under ultrasound guidance before general anesthesia

    Group P was subjected to a pericapsular nerve group (PENG) Block under ultrasound guidance before general anesthesia.

    Procedure: ultrasound-guided pericapsular nerve group (PENG) block

Interventions

  • Procedureultrasound-guided high fascia iliaca compartment block

    H-FICB was guided by ultrasound before general anesthesia. The patient was supine. First, the probe is placed transversely above the groin. Then slide the probe up and down to reveal a clear image of the internal oblique and sartorius muscles. There is a bowtie-like iliac fascia space at the junction of these two muscles. After the scanning, the needle was inserted behind the probe with the tip pointed to the ventral side under the guidance of real-time ultrasound; the tip passed through the skin into the iliac fascia space and advanced to the inguinal ligament. After no blood was extracted, 1 \~ 2 ml of normal saline was firstly injected to determine whether the tip position was correct. If the needle tip was correctly positioned, 0.375% ropivacaine 30 mL of local anesthetic was injected. The H-FICB was performed under ultrasound guidance by the same anesthesiologist.

  • Procedureultrasound-guided pericapsular nerve group (PENG) block

    A low-frequency curvilinear transducer was placed in the transverse plane over the anterior inferior iliac spine (AIIS) and moved over inferiorly to visualize the pubic ramus. The femoral artery and ilio pubic eminence (IPE) were then visualized (Figure 1). Using in-plane technique 10 cm echogenic 21 gauge needle was advanced from lateral to medial direction, and 20 ml of local anesthetic 0.5% ropivacaine was deposited between the psoas tendon anteriorly and pubic ramus posteriorly.

06

What researchers measure

Primary outcomes

  1. Change from Baseline visual analogue scale

    Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 100. A higher score indicates greater pain intensity. Based on the distribution of pain Visual Analogue Scale scores in post-surgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain Visual Analogue Scale have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).

    Time frame: one day before the operation.

  2. Harris Hip Score

    The HHS is divided into three sections. The first section are questions about pain and its impact which are answered by the patient or client. The second and third sections require the physiotherapist to assess the patient or client's hip joint and function.The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following\[1\]: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.

    Time frame: At one week, one month, and three months post-operatively.

Secondary outcomes

  1. The mini-mental State Examination

    The mini-mental State Examination is effective as a screening tool for cognitive impairment in older, community-dwelling, hospitalized, and institutionalized adults. Assessment of an older adult's cognitive function is best achieved when it is done routinely, systematically, and thoroughly. The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points), or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age.

    Time frame: one day before the operation.

07

Study locations

1 of 1 sites recruiting
  • Affiliated Hospital of Nantong University
    Nantong, Jiangsu 0513, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05528822
Lead sponsor
Affiliated Hospital of Nantong University
Responsible party
Sponsor
First posted
Sep 6, 2022
Start date
Dec 1, 2022
Primary completion
Oct 1, 2023 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Feb 6, 2023

Study contacts

Hongsheng Chen
Contact
chenhongsheng8@163.com
0513-81160301
Xingguo Xu
principal investigator · Chair

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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