Transverse Abdominis Plane Block for Anterior Approach Spine Surgery

Low Back Pain Clinical Trial

— TAP ALIF  

Official title:

Transverse Abdominis Plane Block for Anterior Approach Spine Surgery: A Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02884440
• Other study ID #: 35RC15_8933_TAP-ALIF
• Status: Completed
• Phase: Phase 2
• Start date: November 7, 2016
• Est. completion date: May 25, 2019

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

ALIF is a commonly performed procedure for the treatment of degenerative diseases of the lumbar spine or spondylolisthesis. This technique has many advantages attributed to the absence of posterior spinal muscular pain, a more direct visualization of the disk space, lower incidence of neurological injuries… However, patients experienced moderate to high post operative parietal abdominal pain due to this specific anterior approach. The systematic need for opioids administration may cause many complications and delay the post operative recovery time. The TAP block has been described as an effective pain control technique after various lower abdominal surgeries, reducing both pain scores and 24 hours opioids consumption. However the analgesic efficacy of this technique on specific parietal abdominal pain experienced after spine surgery by anterior approach is not clear

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 25, 2019
• Est. primary completion date: May 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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…)
• Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

Related Conditions & MeSH terms

• Low Back Pain
• Spine Surgery
• Spondylolisthesis

Intervention

Drug:
• TAP block ropivacaine

• TAP block placebo

• General anesthesia
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

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & 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 Apr 7:S1529-9430(23)00151-1. doi: 10.1016/j.spinee.2023.03.013. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption in the first 24 hours after spine surgery by anterior approach		24 hours
Secondary	Morphine consumption in the first 48 hours after spine surgery by anterior approach		48 hours
Secondary	Assessment of pain	Numerical Analogue score	1, 6, 12, 24 and 48 hours
Secondary	Assessment of post operative nausea or vomiting	Occurence of nausea or vomiting episodes over 48 hours	48 hours
Secondary	Delay before first morphine administration	Number of hours between end of surgery and first morphine administration	Day 1
Secondary	Delay before the first lift	Number of hours between end of surgery and the first lift	Day 1
Secondary	Delay before resumption of transit	Number of days between end of surgery and resumption of transit	Day 1
Secondary	Duration of hospitalization		Day 1
Secondary	Patient satisfaction	Satisfaction questionnaire	48 hours