MED90 of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain in Spinal Anesthesia Positioning

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-25

Study Completion Date

2024-05-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to determine the minimum effective dose of ropivacaine for peripheral nerve block on posture-evoked pain for spinal anesthesia in elderly patients with hip fracture. Three types of peripheral nerve block, including fascia iliaca block, femoral nerve block and Pericapsular nerve group block (PENG block) will be assessed.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lateral Cutaneous Nerve and PENG Blocks Versus Suprainguinal Fascia Iliaca Block in Post-op Analgesia of Hip Fractures

NCT05749367

Anesthesia, Conduction

UNKNOWN NA

Peri-Capsular Nerve Group and Supra Inguinal Fascia Iliaca BLOCK for Analgesia and Ease of Positioning During Neuraxial Anesthesia in Hip Fracture Patients

NCT05987254

Spinal Anesthesia Hip Fractures

COMPLETED NA

Pericapsular Nerve Group Block for Positional Pain and Postoperative Analgesia in Hip Fractures

NCT05079087

Pertrochanteric Fracture Pain, Postoperative

UNKNOWN NA

Comparing The Effectiveness Of Pericapsular Nerve Group (PENG) Block Versus Supra-Inguinal Fascia Iliaca Compartment Block(S-FICB) In Reducing Positional Pain During Neuraxial Anaesthesia In Hip Fractures Patients

NCT05721924

Hip Fractures

UNKNOWN PHASE4

Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia

NCT04005404

Hip Fractures

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients with hip fractures are anticipated to endure sever pain caused by positional changes required for spinal anesthesia. Providing analgesia before positioning not only increases patient comfort but also improves positioning and successful spinal block. Peripheral nerve block is an effective strategy for relieving pain during postures change for spinal anesthesia in patients with hip fractures. Three types of peripheral nerve block, including fascia iliaca block, femoral nerve block and Pericapsular nerve group block (PENG block), has been successfully used for analgesia for spinal anesthesia positioning in patients with hip fractures. However, the minimum effective dose of local anesthetics for these three types of peripheral nerve block is not known. This study aims to determine the minimum effective dose of ropovacaine in the three types of peripheral nerve block using a biased coin design up-and-down sequential method. Successful block is defined as NRS score ≤3 by positional changes for spinal anesthesia, achieved at 20min after the block. MED90 of ropivacaine for fascia iliaca block, femoral nerve block and PENG block be assessed respectively. Patients will receive ultrasound guided peripheral nerve block. The initial dose is chosen as 80 mg on the basis of clinical experience. Subsequently, if a patient has an inadequate block, the ropivacaine dose is increased by 8 mg in the next subject. If a patient has a successful block, the next subject is randomized to receive either a lower dose (with a decrement of 8 mg), with a probability of b = 0.11, or the same dose, with a probability of 1 - b = 0.89. Forty five successful blocks for each type of nerve block will be accomplished. MED90 of each type of nerve block will be calculated by isotonic regression.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fascia iliaca block

ultrasound-guided fascia iliaca block with predetermined dose of 0.4% ropivacaine will be performed.

Group Type EXPERIMENTAL

Fascia iliaca block

Intervention Type PROCEDURE

Fascia iliaca block will be performed under ultrasound guidenance.

Femoral nerve block

ultrasound-guided ultrasound-guided femoral nerve block with predetermined dose of 0.4% ropivacaine will be performed.

Group Type EXPERIMENTAL

Femoral nerve block

Intervention Type PROCEDURE

Femoral nerve block will be performed under ultrasound guidenance.

Pericapsular nerve group block (PENG block)

ultrasound-guided ultrasound-guided pericapsular nerve group block with predetermined dose of 0.4% ropivacaine will be performed.

Group Type EXPERIMENTAL

Pericapsular nerve group block (PENG block)

Intervention Type PROCEDURE

Pericapsular nerve group block (PENG block) will be performed under ultrasound guidenance.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fascia iliaca block

Fascia iliaca block will be performed under ultrasound guidenance.

Intervention Type PROCEDURE

Femoral nerve block

Femoral nerve block will be performed under ultrasound guidenance.

Intervention Type PROCEDURE

Pericapsular nerve group block (PENG block)

Pericapsular nerve group block (PENG block) will be performed under ultrasound guidenance.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 65 - 85 years
* American Society of Anesthesiologists physical statusⅠ- Ⅲ
* Patients will receive hip replacement

Exclusion Criteria

* Patient refusal
* Cognitive impairment(NRS pain score cannot be assessed)
* Peripheral neuropathy
* Mutiple furacture
* skin infection at the site of injection
* allergy to ropivacaine、lidocaine or bupivacaine
* contraindication to spinal anesthesia

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No