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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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06520306
Enrollment
75
Registered
2024-07-25
Start date
2024-03-15
Completion date
2024-08-31
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Neck Disease

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.

Interventions

Ultrasound-guided fascia iliaca block using different concentrations of methylene blue combined with ropivacaine

Sponsors

Wang wanxia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
visual analogue scale(VAS)The first, third, and seventh days after the surgeryUse 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
Mini-Mental State Examination (MMSE)Seventh day after surgeryAn examination tool to assess cognitive status
Harris Hip Scoring SystemOn the seventh day after surgeryHarris (1969) proposed a scoring system to evaluate the functional status and postoperative efficacy of patients with artificial hip arthroplasty

Secondary

MeasureTime frame
Number of postoperative salvage analgesiaFrom the end of the surgery to the seventh day after the surgery
Walking distance for the first time getting out of bedFrom the end of the surgery to the seventh day after the surgery
Number of exercises to get out of bed within 7 days of surgeryFrom the end of the surgery to the seventh day after the surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026