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

Minimum Effective Dose of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain for Spinal Anesthesia in Patients With Hip Fracture

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Fractures
• Intervention / Treatment: Procedure: Fascia iliaca block; Procedure: Femoral nerve block; Procedure: Pericapsular nerve group block (PENG block)

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yong Liu, Dr.; Phone Number: +86-15007124668; Email: hosp1yong@163.com
• Study Contact Backup: Name: Wei Mei, Dr.; Phone Number: +86-13006162508; Email: wmei@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Department of Anesthesiology, Tongji Hospital
      • Contact: Yong Liu, Dr.; Phone Number: +86-15007124668; Email: hosp1yong@163.com
      • Contact: Wei Mei, Dr.; Phone Number: +86-13006162508; Email: wmei@hust.edu.cn
      • Principal Investigator: Wei Mei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fascia iliaca block; ultrasound-guided fascia iliaca block with predetermined dose of 0.4% ropivacaine will be performed.	Procedure: Fascia iliaca block; Fascia iliaca block will be performed under ultrasound guidenance.
Experimental: Femoral nerve block; ultrasound-guided ultrasound-guided femoral nerve block with predetermined dose of 0.4% ropivacaine will be performed.	Procedure: Femoral nerve block; Femoral nerve block will be performed under ultrasound guidenance.
Experimental: Pericapsular nerve group block (PENG block); ultrasound-guided ultrasound-guided pericapsular nerve group block with predetermined dose of 0.4% ropivacaine will be performed.	Procedure: Pericapsular nerve group block (PENG block); Pericapsular nerve group block (PENG block) will be performed under ultrasound guidenance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The minimum effective dose of ropivacaine in three types of nerve block for analgesia for spinal anesthesia positioning in patients with hip fractures	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.	up to 24 months

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 15, 2024

Study Registration Dates

• First Submitted: January 9, 2021
• First Submitted That Met QC Criteria: January 9, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: MEDNB-HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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