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Clinical Trials/NCT06520306
NCT06520306
Enrolling By Invitation
Not Applicable

A Study of Ropivacaine Combined With Different Concentrations of Methylene Blue Fascia Iliaca Block in Postoperative Analgesia, Cognition, and Hip Function Recovery in Patients Undergoing Hip Arthroplasty

Wang wanxia1 site in 1 country75 target enrollmentMarch 15, 2024

Overview

Phase
Not Applicable
Intervention
Ropivacaine combined with methylene blue for iliac fascia block
Conditions
Femoral Neck Disease
Sponsor
Wang wanxia
Enrollment
75
Locations
1
Primary Endpoint
Mini-Mental State Examination (MMSE)
Status
Enrolling By Invitation
Last Updated
last year

Overview

Brief Summary

Total hip arthroplasty (THA) is a commonly used treatment for hip lesions, but it is often accompanied by persistent pain after surgery, which obviously affects the quality of life of patients, so perfect postoperative analgesia is particularly important for the rapid recovery of patients. Peripheral nerve blocks are often used as postoperative analgesia for THA, and fascia iliaca compartment block (FICB) is the preferred nerve block for THA due to its good postoperative analgesic effect and fewer postoperative adverse reactions. However, the effect of nerve block with ropivacaine alone is short, and the postoperative analgesia time is limited, which seriously affects the patient's surgical recovery. Therefore, prolonging the postoperative analgesic time is an urgent problem to be solved by FICB, and some scholars recommend the combined use of local anesthetic adjuvants to prolong the block time, which is an effective and safe method. In this study, a long-acting analgesic drug, methylene blue, was selected as an adjuvant for ropivacaine for FICB, but there was no unified clinical standard for the postoperative analgesic concentration of methylene blue.

Registry
clinicaltrials.gov
Start Date
March 15, 2024
End Date
August 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Wang wanxia
Responsible Party
Sponsor Investigator
Principal Investigator

Wang wanxia

Principal Investigator

Yangzhou University

Eligibility Criteria

Inclusion Criteria

  • Hip replacement surgery is indicated
  • ASA Class II - Class III
  • No history of analgesic or local anesthetic allergy
  • No history of alcohol abuse or narcotic drug abuse
  • Patients and their families have given informed consent and signed the informed consent form

Exclusion Criteria

  • Patient or family refusal to participate in the study
  • Severe coagulation abnormalities
  • Local anesthetic allergy
  • Severe psychiatric illness or other communication disorder
  • There is an infection at the puncture site

Arms & Interventions

Dilute 0.25% ropivacaine + 20 mg methylene blue to 30 ml

Intervention: Ropivacaine combined with methylene blue for iliac fascia block

0.25% ropivacaine + 40 mg methylene blue diluted to 30 ml

Intervention: Ropivacaine combined with methylene blue for iliac fascia block

Outcomes

Primary Outcomes

Mini-Mental State Examination (MMSE)

Time Frame: Seventh day after surgery

An examination tool to assess cognitive status

visual analogue scale(VAS)

Time Frame: The first, third, and seventh days after the surgery

Use a swimming ruler about 10 cm long, marked with 10 ticks on one side, and "0" and "10" at each end. A score of 0 indicates no pain, a score of 10 indicates the most severe pain that is unbearable, and the higher the score, the greater the degree of pain

Harris Hip Scoring System

Time Frame: On the seventh day after surgery

Harris (1969) proposed a scoring system to evaluate the functional status and postoperative efficacy of patients with artificial hip arthroplasty

Secondary Outcomes

  • Number of postoperative salvage analgesia(From the end of the surgery to the seventh day after the surgery)
  • Walking distance for the first time getting out of bed(From the end of the surgery to the seventh day after the surgery)
  • Number of exercises to get out of bed within 7 days of surgery(From the end of the surgery to the seventh day after the surgery)

Study Sites (1)

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