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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 65 to 80 years
• All sexes
• No healthy volunteers
• Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Comparative Prospective Randomized Study of Modified Fascia Iliaca Compartment Block Versus Pericapsular Nerve Group Block in Elderly Patients' Total Hip Arthroplasty on the Post-operative Quality of Recovery

Conditions

Nerve Block, Quality of Recovery

Being tested

ultrasound-guided high fascia iliaca compartment block, ultrasound-guided pericapsular nerve group (PENG) block

Keywords

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• ultrasound-guided high fascia iliaca compartment blockProcedure or surgery

  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.

• ultrasound-guided pericapsular nerve group (PENG) blockProcedure or surgery

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).

   Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Sep 2022
2. Study start1 Dec 2022
3. Primary completion1 Oct 2023 (estimated)
4. Study completion1 Dec 2023 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Nerve BlockStudies of the same condition, open and under way.
• More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.