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

Not Applicable

• Conditions: Hip Fractures
• Interventions: Procedure: Fascia iliaca block; Procedure: Femoral nerve block; Procedure: Pericapsular nerve group block (PENG block)

• Registration Number: NCT04705974
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-01-09
• Study First Submitted QC: 2021-01-09
• Study First Posted: 2021-01-12
• Status Verified: 2022-01
• Study Start: 2022-01-25
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-02-09
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Fascia iliaca block	Fascia iliaca block	ultrasound-guided fascia iliaca block with predetermined dose of 0.4% ropivacaine will be performed.
Femoral nerve block	Femoral nerve block	ultrasound-guided ultrasound-guided femoral nerve block with predetermined dose of 0.4% ropivacaine will be performed.
Pericapsular nerve group block (PENG block)	Pericapsular nerve group block (PENG block)	ultrasound-guided ultrasound-guided pericapsular nerve group block with predetermined dose of 0.4% ropivacaine will be performed.

Primary Outcome Measures

Name	Time	Method
The minimum effective dose of ropivacaine in three types of nerve block for analgesia for spinal anesthesia positioning in patients with hip fractures	up to 24 months	The minimum effective dose of ropivacaine in each type of nerve block is based on 45 patients with satisfactory analgesia during positioning for spinal anesthesia.

Trial Locations

Locations (1)

Department of Anesthesiology, Tongji Hospital; 🇨🇳 Wuhan, Hubei, China