Ignite Creation Date:
2024-05-06 @ 8:35 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02778178
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2016-05-18
Brief Title:
TAP Block Efficacy After Lumbar Spine Surgery Through Anterior Approach a Randomized Placebo-controlled Study
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAP-LIF
Brief Summary:
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 ALIFDLIF 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 ALIFDLIF surgery
Detailed Description:
Clinical trial therapeutic prospective randomizeddouble 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 n20 OR saline control group n20
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
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 n20 OR saline control group n20
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-002143-34 | EUDRACT_NUMBER | None | None |