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

Not Applicable

Recruiting

• Conditions: Nerve Block; Quality of Recovery
• Interventions: Procedure: ultrasound-guided high fascia iliaca compartment block; Procedure: ultrasound-guided pericapsular nerve group (PENG) block

• Registration Number: NCT05528822
• Lead Sponsor: Affiliated Hospital of Nantong University

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.

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.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-06
• Study Start: 2022-12-01
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-06
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group F: H-FICB under ultrasound guidance before general anesthesia	ultrasound-guided high fascia iliaca compartment block	Group F was subjected to a high fascia iliaca compartment block under ultrasound guidance before general anesthesia.
Group P: PENG block under ultrasound guidance before general anesthesia	ultrasound-guided pericapsular nerve group (PENG) block	Group P was subjected to a pericapsular nerve group (PENG) Block under ultrasound guidance before general anesthesia.

Primary Outcome Measures

Name	Time	Method
Change from Baseline visual analogue scale	one day before the operation.	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).
Harris Hip Score	At one week, one month, and three months post-operatively.	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.

Secondary Outcome Measures

Name	Time	Method
The mini-mental State Examination	one day before the operation.	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.

Trial Locations

Locations (1)

Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China