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

NCT ID: NCT06520306

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2024-08-31

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.

Conditions

Femoral Neck Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Ropivacaine combined with methylene blue for iliac fascia block

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Ropivacaine combined with methylene blue for iliac fascia block

Intervention Type: DRUG

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

0.25% ropivacaine 30 ml

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ropivacaine combined with methylene blue for iliac fascia block

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wang wanxia

OTHER

Sponsor Role: lead

Responsible Party

Wang wanxia

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Zhang Yang

Taizhou, , China

Countries

China

Other Identifiers

ZY 0717

Identifier Type: -

Identifier Source: org_study_id