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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

Plain-language guide to NCT06520306: not phased randomized trial of Methylene blue (non-peptide stack partner), 75 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06520306
Phase
not phased
Status
status unknown
Start
2024-03-15
Completion (planned or actual)
2024-08-31
Participants
75 (estimated)
Design
randomized, double-blind, other
Conditions studied
Femoral Neck Disease
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Methylene blue (non-peptide stack partner).

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.

It had three arms (groups): one (experimental), one (experimental) and one (no intervention).

The registry classes the interventions as drug.

Who Took Part

75 planned participants were the target.

It was open to people of any sex aged from 60 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: patient or family refusal to participate in the study; severe coagulation abnormalities; local anesthetic allergy.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Methylene blue (non-peptide stack partner), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2024-03-15 with completion listed for 2024-08-31.

It ran at 1 site in China.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): visual analogue scale(VAS) (time frame: The first, third, and seventh days after the surgery). Mini-Mental State Examination (MMSE) (time frame: Seventh day after surgery). Harris Hip Scoring System (time frame: On the seventh day after surgery).

It also tracked 3 secondary outcomes, for example Number of postoperative salvage analgesia, Walking distance for the first time getting out of bed and Number of exercises to get out of bed within 7 days of surgery.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 75 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.

Our Notes on the Compound

Methylene blue (non-peptide stack partner): Described as an electron cycler, not just a dye.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.