TAP Block Efficacy After Lumbar Spine Surgery Through Anterior Approach: a Randomized, Placebo-controlled Study (TAP-LIF)

May 18, 2017 updated by: University Hospital, Lille

Analgesic Efficacy of Transversus Abdominis Plane (TAP) Block After Lumbar Spine Surgery Through Anterior Approach (Anterior Lumbar or Direct Lateral Interbody Fusion): a Prospective, Randomized, Double-blind Placebo-controlled Study

Anterior Lumbar Interbody Fusion (ALIF) as well as Direct Lateral Interbody Fusion (DLIF) are established techniques for lumbar interbody fusion. In contrast with posterior approaches, they allow free approach to the anterior disc space without opening of the spinal canal or the neural foramina. However, the additional anterior approach conveys specific concerns, including abdominal pain that may delay recovery after surgery. The transversus abdominis plane (TAP) block is a validated approach for postoperative pain relief following abdominal surgeries. There is currently no evidence of the possible benefits of TAP block as part of multimodal pain management after ALIF/DLIF surgery. The investigator hypothesize that a single-injection TAP block reduces opioid consumption after anterior lumbar fusion surgery. The main goal of this prospective, randomized, double-blind, placebo-controlled study is to demonstrate a >35% reduction in opioid consumption during the 24h following ALIF/DLIF surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Clinical trial : therapeutic, prospective, randomized,double blind, placebo-controlled, with parallel group, of superiority, in intention to treat, monocentric study.

The main steps of the study are:

  • preoperative assessment of eligibility
  • exclusion and inclusion criteria, written informed consent, baseline preoperative assessment (see specific section)
  • randomization (using a computer generated list) immediately before induction of anesthesia
  • TAP block: ropivacaine + clonidine (experimental group, n=20) OR saline (control group; n=20)
  • anesthesia (propofol, sufentanil, cisatracurium, ketamine and desflurane) and postoperative analgesia (paracetamol, ketoprofen, nefopam, and patient-controlled analgesia with morphine) similar in both groups
  • surgical procedure
  • primary outcome parameter (morphine consumption first 24 hours; see specific section)
  • secondary endpoints (see specific section, up to 6 months following surgery)

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Roger Salengro, CHU de Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Man or woman over the age of 18 yr
  • Patients with insurance coverage
  • Patients able to provide free and informed consent
  • Patients undergoing surgery by the ALIF or DLIF approaches

Exclusion Criteria:

  • Patients receiving opioids as chronic treatment
  • Patients with contra-indication to regional anesthesia or TAP block
  • Patients unable to consent
  • Patient refusal
  • Patients with contra-indication to any drug included in the anesthesia or analgesia protocol
  • Pregnancy or breast-feeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TAP block with ropivacaine
Bilateral single shot TAP block under ultrasound guidance: 20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side
Device: ultrasound
Drug: ropivacaine plus clonidine
20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side
PLACEBO_COMPARATOR: TAP block with placebo
Placebo administration: bilateral single shot TAP block under ultrasound guidance: 20 mL saline 0.9%, per side
Device: ultrasound
Drug: Placebo
20 mL saline 0.9%, per side

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: During the first 24 postoperative hours
patient-controlled administration
During the first 24 postoperative hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative sufentanil consumption
Time Frame: At the end of anesthesia
infusion adjusted according to heart rate and arterial pressure
At the end of anesthesia
Sedation scale
Time Frame: During the first 6 hours

using WHO Sedation scale

- 0 = awake and alert /- 1 = quietly awake / - 2 = asleep but easily roused / - 3 = deep sleep
During the first 6 hours
Morphine consumption
Time Frame: between the 24 and the 48 postoperative hours
patient-controlled administration
between the 24 and the 48 postoperative hours
Postoperative nausea and vomiting (PONV) Score
Time Frame: first 24 postoperative hours
Measure the presence and severity of postoperative nausea and vomiting the PONV score :- 1 = mild /- 2 = moderate / - 3 = severe
first 24 postoperative hours
Antiemetics consumption
Time Frame: During the first 24 postoperative hours
During the first 24 postoperative hours
resumption of intestinal transit
Time Frame: Up to the end of hospital stay
Up to the end of hospital stay
visual analog scale
Time Frame: At Baseline, at wake up, during the first 48 postoperative hours, At 3 and 6 months after surgery
Measure the pain severity
At Baseline, at wake up, during the first 48 postoperative hours, At 3 and 6 months after surgery
Area peri-incisional hyperalgesia
Time Frame: At 48 hours
von frey's hair
At 48 hours
Questionnaire Douleur de Saint-Antoine (QDSA) ,
Time Frame: At Baseline, At 3 and 6 months after surgery
evaluation with validated scores for chronic and neuropathic pains
At Baseline, At 3 and 6 months after surgery
Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),
Time Frame: At Baseline, At 3 and 6 months after surgery
evaluation with validated scores for chronic and neuropathic pains
At Baseline, At 3 and 6 months after surgery
Sullivan's "pain catastrophising scale",
Time Frame: At Baseline, At 3 and 6 months after surgery
evaluation with validated scores for chronic and neuropathic pains
At Baseline, At 3 and 6 months after surgery
Hospital Anxiety and Depression Scale (HAD scale),
Time Frame: At Baseline, At 3 and 6 months after surgery
evaluation with validated scores for chronic and neuropathic pains
At Baseline, At 3 and 6 months after surgery
Oswestry score
Time Frame: At Baseline, At 3 and 6 months after surgery
evaluation with validated scores for chronic and neuropathic pains
At Baseline, At 3 and 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2016

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (ESTIMATE)

May 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 18, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-52
  • 2015-002143-34 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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