Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration.

NCT02481505 | Completed Phase 2 Results

• 2 other identifiers: CHL.1/02-20142014-003778-17
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluate the effect of 3 doses of Chloroprocaine HCl 1% (30, 40 and 50 mg) for spinal anaesthesia in adult patients undergoing short duration elective surgery of the lower limb. Patients undergoing elective short-duration lower limb surgery will be randomised into 3 treatment groups (15 patients per group) to receive one of the 3 single doses of Chloroprocaine HCl 1%, i.e. either D1, D2 or D3, via intrathecal injection.

Conditions

Short Duration Lower Limb Surgery Via Spinal Anaesthesia

Outcome Measures

Primary Outcomes (1)

• Time to Regression of Spinal Block

  When Bromage score returns to 0 and sensitive perception returns to S1 To evaluate the efficacy of the three Chloroprocaine HCI 1% doses (i.e. 30 mg, 40 mg e 50 mg) in terms of time to complete regression of spinal block (i.e. end of anaesthesia) Bromage Score is comprised between 1 and 4 (1 equals Free movement of legs and feet while 4 stands for Unable to move legs or feet)

  Up to 5 hours after regression of two dermatomers

Secondary Outcomes (23)

• Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)

  Up to 40 min after spinal injection

• Time to Onset of Motor Block

  Up to 40 min after spinal injection

• Time to Readiness for Surgery

  Up to 40 min after spinal injection

• Time to Regression of Spinal Block

  Up to 1 h and 40 min after readiness for surgery

• Time to Resolution of Sensory Block to S1(Min)

  Up to 5 h after regression of two dermatomers

Study Arms (3)

3 mL Chloroprocaine HCl 1%

EXPERIMENTAL

Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)

Drug: Chloroprocaine HCl 1%

4 mL Chloroprocaine HCl 1%

EXPERIMENTAL

Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)

Drug: Chloroprocaine HCl 1%

5 mL Chloroprocaine HCl 1%

EXPERIMENTAL

Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)

Drug: Chloroprocaine HCl 1%

Interventions

Chloroprocaine HCl 1% DRUG

Intrathecal Route

Also known as: Ampres 1%

3 mL Chloroprocaine HCl 1%; 4 mL Chloroprocaine HCl 1%; 5 mL Chloroprocaine HCl 1%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sex, age and surgery: male/female patients, 18-65 years old, scheduled for short duration (less than 40 min) lower limb surgery requiring ≥ T12 metameric level of sensory block
• Body Mass Index (BMI): 18 - 32 kg/m2 inclusive
• ASA physical status: I-II

You may not qualify if:

• Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to spinal anaesthesia. History of neuromuscular diseases to the lower extremities
• ASA physical status: III-V
• Further anaesthesia: patients expected to require further anaesthesia
• Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the ester type and major anaesthetics
• Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric and neurological diseases, sepsis, blood coagulation disorders, severe cardiopulmonary disease, thyroid disease, diabetes or other neuropathies.
• Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study, calculated from the first day of the month following the last visit of the previous study
• Drug, alcohol: history of drug or alcohol abuse
• Blood donation: blood donations in the 3 months before this study
• Pregnancy and lactation: missing or positive pregnancy test at screening, pregnant or lactating women
• Chronic pain syndromes: patients with chronic pain syndromes (taking opioids, antidepressants, anticonvulsant agents or chronic analgesic therapy) 11. Medications: medication known to interfere with the extent of spinal blocks for 2 weeks before the start of the study. Hormonal contraceptives for females are allowed.

Sponsors & Collaborators

• Sintetica SA: lead
• Cross S.A.: collaborator

Study Sites (1)

Stefano Bonarelli

Bologna, 40136, Italy

Location

Related Publications (1)

• Ghisi D, Boschetto G, Spinelli AM, Giannone S, Frugiuele J, Ciccarello M, Bonarelli S. Spinal anaesthesia with Chloroprocaine HCl 1% for elective lower limb procedures of short duration: a prospective, randomised, observer-blind study in adult patients. BMC Anesthesiol. 2021 Feb 20;21(1):58. doi: 10.1186/s12871-021-01279-9.

  PMID: 33610175 DERIVED

Results Point of Contact

• Title: Elisabetta Donati Clinical Project Leader
• Organization: Sintetica SA, via Penate 5 Mendrisio

edonati@sintetica.com

+41.91.640.42.50

Study Officials

• Stefano MD Bonarelli

  Istituto Ortopedico Rizzoli, SC Anestesia e Terapia Intensiva post-operatoria e del dolore IOR-IRCCS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 25, 2015
• Study Start: June 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 18, 2021
• Results First Posted: May 18, 2021

Record last verified: 2021-04

Locations

IT (1)