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Clinical Trials/NCT05528822
NCT05528822
Recruiting
N/A

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

Affiliated Hospital of Nantong University1 site in 1 country100 target enrollmentDecember 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Nerve Block
Sponsor
Affiliated Hospital of Nantong University
Enrollment
100
Locations
1
Primary Endpoint
Change from Baseline visual analogue scale
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
December 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from Baseline visual analogue scale

Time Frame: 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

Time Frame: 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 Outcomes

  • The mini-mental State Examination(one day before the operation.)

Study Sites (1)

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