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

NCT05528822 | Unknown

• 1 other identifier: 2021-K090
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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).

  one day before the operation.

• 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.

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

Secondary Outcomes (1)

• The mini-mental State Examination

  one day before the operation.

Study Arms (2)

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

EXPERIMENTAL

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

Group P: PENG block under ultrasound guidance before general anesthesia

EXPERIMENTAL

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

ultrasound-guided high fascia iliaca compartment block PROCEDURE

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.

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

ultrasound-guided pericapsular nerve group (PENG) block PROCEDURE

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.

Group P: PENG block under ultrasound guidance before general anesthesia

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 0513, China

RECRUITING

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Xingguo Xu

  Chair

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongsheng Chen

CONTACT

0513-81160301; chenhongsheng8@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: December 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 6, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)