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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04705974
• Other study ID #: MEDNB-HP
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: May 15, 2024

Study information

• Verified date: January 2022
• Source: Huazhong University of Science and Technology
• Contact: Yong Liu, Dr.
• Phone: +86-15007124668
• Email: hosp1yong[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 15, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age 65 - 85 years

• American Society of Anesthesiologists physical status?- ?

• 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

Related Conditions & MeSH terms

• Hip Fractures

Intervention

Procedure:
• Fascia iliaca block
Fascia iliaca block will be performed under ultrasound guidenance.
• Femoral nerve block
Femoral nerve block will be performed under ultrasound guidenance.
• Pericapsular nerve group block (PENG block)
Pericapsular nerve group block (PENG block) will be performed under ultrasound guidenance.

Locations

Country	Name	City	State
China	Department of Anesthesiology, Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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