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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Femoral Neck Disease
• Intervention / Treatment: Drug: Ropivacaine combined with methylene blue for iliac fascia block

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Taizhou, China
    • Zhang Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dilute 0.25% ropivacaine + 20 mg methylene blue to 30 ml	Drug: Ropivacaine combined with methylene blue for iliac fascia block; Ultrasound-guided fascia iliaca block using different concentrations of methylene blue combined with ropivacaine
Experimental: 0.25% ropivacaine + 40 mg methylene blue diluted to 30 ml	Drug: Ropivacaine combined with methylene blue for iliac fascia block; Ultrasound-guided fascia iliaca block using different concentrations of methylene blue combined with ropivacaine
No Intervention: 0.25% ropivacaine 30 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale（VAS）	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	The first, third, and seventh days after the surgery
Mini-Mental State Examination (MMSE)	An examination tool to assess cognitive status	Seventh day after surgery
Harris Hip Scoring System	Harris (1969) proposed a scoring system to evaluate the functional status and postoperative efficacy of patients with artificial hip arthroplasty	On the seventh day after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Wang wanxia

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: July 21, 2024
• First Submitted That Met QC Criteria: July 21, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 21, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine; Methylene Blue
• Other Study ID Numbers: ZY 0717

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No