Remote Controlled Analgesia on Patient Experience

NCT02720965 | Completed DMC

• 1 other identifier: 9677
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to compare the efficacy of continuous nerve blocks with single injection in terms of perioperative patient satisfaction after scheduled orthopedic ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain Catastrophizing Scale (PCS) and type of surgery. Secondary objectives comprise the assessment of pain, readmission rates, patient mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about quality of recovery will be performed on day 1, about quality of life on day 45 and presence of neuropathic pain will be screened at 3 months. An economic study will also be conducted, including work resumption at 3 months. This is a multicentric prospective study. Three hundred patients will be randomized in two parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump versus single local anesthetics injection. The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary endpoints will include assessment of pain, opiates consumption, sensitivity and motricity scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4) at day 90.

Conditions

Orthopaedic Surgery

Keywords

Pain Acute; Orthopedic Surgery; Satisfaction Nerve Blocks

Outcome Measures

Primary Outcomes (1)

• Patient experience and satisfaction scale (EVAN-G)

  Description: Patient experience and satisfaction scale

  Second day after surgery

Secondary Outcomes (1)

• Patient quality of recovery (QoR)

  First day after surgery

Study Arms (2)

Electronic pump

EXPERIMENTAL

Continuous nerve blocks Remote-controlled perineural local anesthetics delivery

Other: Remote-controlled perineural local anesthetics delivery

single injection

NO INTERVENTION

single injection

Interventions

Remote-controlled perineural local anesthetics delivery OTHER

Remote-controlled perineural local anesthetics delivery

Electronic pump

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject aged 18 or more, up to 80 years;
• Undergoing potentially painful scheduled orthopedic surgery under general anesthesia.
• Eligible to outpatient care;
• Respecting the ambivalence clause defined below:
• no cons-indication to analgesic perineural catheter;
• not known allergy to local anesthetics;
• likely to be a candidate for continuous nerve block analgesia;
• Ability to complete a self-reported questionnaire;
• Have given written informed consent

You may not qualify if:

• Age less than 18 or more than 80 years;
• Pregnant or nursing women ;
• Not being affiliated to the social security scheme;
• Known allergy to local anesthetics of the amide type;
• Regulatory constraints in the outpatient management of perineural catheters not respected:
• Inability of daily nursing care;
• No presence of a responsible adult at home the night of the intervention;
• Scheduled hospital stay;
• ASA physical status score (American Society of Anesthesiologists) above 3 or 3 unsteady;
• Spontaneous request for continuous nerve block or single injection;
• Topic unable to fulfill only a self-administered questionnaire (inability to read French, severe cognitive impairment);
• Subject with cognitive impairment already documented (Alzheimer, dementia, neurological sequelae);
• Topic treated with antipsychotics (neuroleptics or lithium);
• Subject has a documented chronic pain syndrome;
• Active consumer of narcotic topic;

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Department of Anesthesiology and critical care, Lapeyronie University Hospital

Montpellier, 34295, France

Location

Related Publications (1)

• Maurice-Szamburski A, Grillo P, Cuvillon P, Gazeau T, Delaunay L, Auquier P, Bringuier S, Capdevila X. Comparison of continuous with single-injection regional analgesia on patient experience after ambulatory orthopaedic surgery: a randomised multicentre trial. Br J Anaesth. 2022 Sep;129(3):435-444. doi: 10.1016/j.bja.2022.05.039. Epub 2022 Jul 7.

  PMID: 35811140 DERIVED

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xavier CAPDEVILA, M.D., Ph.D.

  University Hospital, Montpellier

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: March 28, 2016
• Study Start: June 7, 2016
• Primary Completion: October 21, 2019
• Study Completion: December 2, 2019
• Last Updated: April 3, 2020

Record last verified: 2016-03

Locations

FR (1)