NCT02884440

Brief Summary

Therapeutic, prospective, randomized, double blind, placebo-controlled, in intention to treat, monocentric study to evaluate the analgesic efficacy of a bilateral TAP block after spine surgery with 24 hours morphine consumption

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 7, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2019

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

2.5 years

First QC Date

August 22, 2016

Last Update Submit

May 22, 2023

Conditions

Spine SurgeryLow Back PainSpondylolisthesis

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption in the first 24 hours after spine surgery by anterior approach

    24 hours

Secondary Outcomes (8)

  • Morphine consumption in the first 48 hours after spine surgery by anterior approach

    48 hours

  • Assessment of pain

    1, 6, 12, 24 and 48 hours

  • Assessment of post operative nausea or vomiting

    48 hours

  • Delay before first morphine administration

    Day 1

  • Delay before the first lift

    Day 1

  • +3 more secondary outcomes

Study Arms (2)

TAP block ropivacaine

EXPERIMENTAL

Bilateral ultrasound guided with 15 ml ropivacaine 5mg/ml on each side under general anesthesia at the end of the intervention

Drug: TAP block ropivacaineDrug: General anesthesia

TAP block placebo

PLACEBO COMPARATOR

Bilateral ultrasound guided with 15 ml saline on each side under general anesthesia at the end of the intervention

Drug: TAP block placeboDrug: General anesthesia

Interventions

TAP block ropivacaineDRUG
TAP block ropivacaine
TAP block placeboDRUG
TAP block placebo
General anesthesiaDRUG

Induction PROPOFOL 10mg/ml REMIFENTANIL 50 μg/ml CISATRACURIUM 2mg/ml if necessary DEXAMETHASONE 8 mg KETAMINE 0,15mg/kg Maintenance PROPOFOL 10mg/ml REMIFENTANIL 50 μg/ml

TAP block placeboTAP block ropivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with age above 18 years old
  • Patients scheduled for spine surgery by anterior approach
  • Patient who signed an informed consent form

You may not qualify if:

  • Allergy to ropivacaine
  • Weight \< 50 kg
  • Contra indication to TAP block : sepsis in the point of draining, bleeding disorder
  • Contra indication to paracetamol: severe hepatic insufficiency
  • Contra indication to ketoprofen: age ≥ 75 years, renal insufficiency, previous gastric ulcer, allergy
  • Contra indication to nefopam: severe cardiac insufficiency, glaucoma, prostate hypertrophy, allergy
  • Known allergy to active substance or at least to one excipient (propofol, paracetamol, morphine, remifentanil, cisatracurium)
  • Allergy to fentanyl, atracurium, or benzin sulfonic acid derivative, to propacetamol
  • Convulsions or previous convulsive disorder
  • Severe respiratory insufficiency
  • Abnormal hemostasis or anticoagulant treatment because of possible intramuscular injection
  • Morphine intake 24 hours before surgery
  • Chronic use of morphine, gabapentin, pregabalin
  • Pregnancy or breastfeeding
  • Patient unable to use Patient Controlled Analgesia (PCA) (old patient depends…)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

Related Publications (1)

  • Coquet A, Sion A, Bourgoin A, Ropars M, Beloeil H. Transversus abdominis plane block for anterior lumbar interbody fusion: a randomized controlled trial. Spine J. 2023 Aug;23(8):1137-1143. doi: 10.1016/j.spinee.2023.03.013. Epub 2023 Apr 7.

    PMID: 37031893RESULT

MeSH Terms

Conditions

Low Back PainSpondylolisthesis

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 31, 2016

Study Start

November 7, 2016

Primary Completion

May 25, 2019

Study Completion

May 25, 2019

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)