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Transverse Abdominis Plane Block for Anterior Approach Spine Surgery (TAP ALIF)

Primary Purpose

Spine Surgery, Low Back Pain, Spondylolisthesis

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

TAP block ropivacaine

TAP block placebo

General anesthesia

About this trial

This is an interventional treatment trial for Spine Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU de Rennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TAP block ropivacaine

TAP block placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Assessment of pain

Numerical Analogue score

Assessment of post operative nausea or vomiting

Occurence of nausea or vomiting episodes over 48 hours

Delay before first morphine administration

Number of hours between end of surgery and first morphine administration

Delay before the first lift

Number of hours between end of surgery and the first lift

Delay before resumption of transit

Number of days between end of surgery and resumption of transit

Duration of hospitalization

Patient satisfaction

Satisfaction questionnaire

Full Information

NCT ID

NCT02884440

First Posted

August 22, 2016

Last Updated

May 22, 2023

Sponsor

Rennes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02884440

Brief Title

Transverse Abdominis Plane Block for Anterior Approach Spine Surgery

Acronym

TAP ALIF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

November 7, 2016 (Actual)

Primary Completion Date

May 25, 2019 (Actual)

Study Completion Date

May 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rennes University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spine Surgery, Low Back Pain, Spondylolisthesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TAP block ropivacaine

Arm Type

Experimental

Arm Description

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

Arm Title

TAP block placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

TAP block ropivacaine

Intervention Type

Drug

Intervention Name(s)

TAP block placebo

Intervention Type

Drug

Intervention Name(s)

General anesthesia

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

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

Time Frame

48 hours

Title

Assessment of pain

Description

Numerical Analogue score

Time Frame

1, 6, 12, 24 and 48 hours

Title

Assessment of post operative nausea or vomiting

Description

Occurence of nausea or vomiting episodes over 48 hours

Time Frame

48 hours

Title

Delay before first morphine administration

Description

Number of hours between end of surgery and first morphine administration

Time Frame

Day 1

Title

Delay before the first lift

Description

Number of hours between end of surgery and the first lift

Time Frame

Day 1

Title

Delay before resumption of transit

Description

Number of days between end of surgery and resumption of transit

Time Frame

Day 1

Title

Duration of hospitalization

Time Frame

Day 1

Title

Patient satisfaction

Description

Satisfaction questionnaire

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

CHU de Rennes

City

Rennes

ZIP/Postal Code

35033

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

37031893

Citation

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.

Results Reference

result

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Transverse Abdominis Plane Block for Anterior Approach Spine Surgery

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