Remote Controlled Analgesia on Patient Experience

NCT ID: NCT02720965

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-07
• Study Completion Date: 2019-12-02

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.

Detailed Description

Acute postoperative pain is poorly treated. More than three-quarters of patients complain of pain, from moderate to extreme, after surgery. In orthopedic surgery, continuous nerve blocks analgesia has proved effective among in-hospital patients but single injection strategy is easier to implement in the growing outpatient setting.

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.

The inclusion criteria are adults undergoing outpatient scheduled orthopedic surgery under general anesthesia with regional analgesia.

Non-inclusion criteria are patients over 80 years, documented cognitive impairment, inability to complete a self-administered questionnaire, presenting American Society of Anesthesiology (ASA) physical status 3 unsteady or 4, or spontaneously requiring analgesic perineural catheter or a single injection of local anesthetics.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Electronic pump

Continuous nerve blocks Remote-controlled perineural local anesthetics delivery

Group Type: EXPERIMENTAL

Remote-controlled perineural local anesthetics delivery

Intervention Type: OTHER

Remote-controlled perineural local anesthetics delivery

single injection

single injection

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Remote-controlled perineural local anesthetics delivery

Remote-controlled perineural local anesthetics delivery

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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:

1. no cons-indication to analgesic perineural catheter;

2. not known allergy to local anesthetics;

3. likely to be a candidate for continuous nerve block analgesia;

• Ability to complete a self-reported questionnaire;
• Have given written informed consent

Exclusion Criteria

• 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:

1. Inability of daily nursing care;

2. 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;
• Topic have not signed informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier CAPDEVILA, M.D., Ph.D.

Role: STUDY_CHAIR

University Hospital, Montpellier

Locations

Department of Anesthesiology and critical care, Lapeyronie University Hospital

Montpellier, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 35811140 (View on PubMed)

Other Identifiers

9677

Identifier Type: -

Identifier Source: org_study_id