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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04473508
Other study ID # LOCAL/2018/PC-02
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 27, 2019
Est. completion date September 9, 2021

Study information

Verified date March 2022
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

: Spine surgery induced severe postoperative pain. Several techniques as intravenous multimodal analgesia have been proposed to reduce pain relief and morphine rescue over the first postoperative days. Regional anesthesia using the erectus nerve block is a simple infiltration across lamina of the vertebra: Ultrasound-guided posterior ramus of spinal nerve block for anesthesia and analgesia in lumbar spinal surgery This study compared erector nerve block with local anesthetic vs placebo to reduce pain and morphine rescue after lumbar spine surgery. The investigators hypothesized that eructor nerve block induced a large block from L1 to L5 that induced posterior nerve roots block anesthesia. This block reduced pain after surgery.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 9, 2021
Est. primary completion date June 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - age> 18years and <80 years - lumbar spine surgery (2-4 levels) - posterior approach - ASA 1-3 Exclusion Criteria: - refusal - age < 18yrs - <50 kg and >120 kg - pregnant - renal or hepatic severe desease - ASA 4 - no French speaking - emergency surgery - local or systemic infection - surgical resumption of the surgical site - surgery involving a thoracic approach - allergy to local anesthetics

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Local administration of ropivacaine
Erector nerve block with local ropivacaine injection in addition with conventional anesthesia for spine surgery
Local administration of placebo (saline solution)
injection of saline solution in addition with conventional anesthesia for spine surgery

Locations

Country Name City State
France CHU Nimes Nîmes Gard

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary morphine consumption (mg) Quantity administered in the post-interventional monitoring room and in hospitalization via a self-controlled morphine pump by the patient 24 Hours after surgery
Secondary Adverse events Nausea, vomiting, confusion, urinary retention, hematoma, reintervention from surgery to 3 months
Secondary pain at rest and at movement: Visual Analogic scale Visual Analogic scale of pain (0-10) Day 1 to Day 3, Day od hospital discharge and month 3
Secondary chronic pain: DN4 questionnaire pain score as mesured with DN4 questionnaire Questionnaire DN4 at 3 months
Secondary Length of hospital stay Number of day in hospital hospital length of stay, an average of 4 days
Secondary Length of stay in the post-intervention care unit Number of minutes that patient stay in post intervention care unit in minutes Day 1
Secondary Patient Satisfaction: visual analogic scale Patient satisfaction mesured with a visual analogic scale (0-10) Day of hospital discharge, an average of day 4
Secondary Patient Quality of life: EQ-5D Questionnaire Patient Quality of life mesured with EQ-5D Questionnaire 3 months
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