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An mTLIP Block for Analgesia Management After Lumbar Spinal Surgery.

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TLIP block group (group T)
Wound infiltration group (group W)
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Lumbar spinal surgery, Postoperative pain management, Modified thoracolumbar interfacial plane block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for lumbar discectomy/hemilaminectomy surgery under general anesthesia

Exclusion Criteria:

  • Bleeding diathesis
  • Receiving anticoagulant treatment
  • Known local anesthetics and opioid allergy
  • Infection of the skin at the site of the needle puncture
  • Pregnancy or lactation
  • Patients who do not accept the procedure

Sites / Locations

  • Istanbul Medipol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group T = TLIP block group

Group W = Wound infiltration group

Arm Description

After the induction of anesthesia and placement of the patient in a prone position, US-guided mTLIP block was performed via the lateral approach in group T. For postoperative analgesia, a dose of 1 g of paracetamol (IV) was administered routinely, every 8 h. All the patients received fentanyl via a patient-controlled analgesia device. The protocol was a 20 mcg bolus without an infusion dose, 20-min lockout time, and 4-h limit

After the induction of anesthesia and placement of the patient in a prone position wound infiltration was performed in group W. For postoperative analgesia, a dose of 1 g of paracetamol (IV) was administered routinely, every 8 h. All the patients received fentanyl via a patient-controlled analgesia device. The protocol was a 20 mcg bolus without an infusion dose, 20-min lockout time, and 4-h limit

Outcomes

Primary Outcome Measures

Opioid consumption by the patients at postoperative 24 hours period
Fentanyl using

Secondary Outcome Measures

Postoperative pain scores
Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 0, 2, 4, 8, 16 and 24 hours.

Full Information

First Posted
May 22, 2019
Last Updated
May 27, 2019
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT03967314
Brief Title
An mTLIP Block for Analgesia Management After Lumbar Spinal Surgery.
Official Title
A Comparison of Ultrasound-Guided Modified-Thoracolumbar Interfacial Plane Block and Wound Infiltration for Postoperative Pain Management in Lumbar Spinal Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pain management is an important issue following lumbar spinal surgery. Wound infiltration is a technique that a local anesthetic solution is infiltrated into the tissues around the surgical area. Modified thoracolumbar interfacial plane (mTLIP) block was described by Ahiskalioglu et al. In this study, the investigators aimed to compare the analgesic efficacy of the US-guided mTLIP block and wound infiltration following lumbar disc surgery.
Detailed Description
Spinal surgery in the lumbar region is one of the most common surgeries performed for leg and back pain. Postlumbar surgery pain can be severe and may progress to chronic pain during the postoperative period. Therefore, pain management is important after lumbar spinal surgery. Effective postoperative pain management enables early mobilization and shorter durations of hospital stays and may also reduce hospitalization-related complications, such as infections and thromboembolism. There are a variety of techniques for postoperative pain management. These include intravenous-intramuscular injections, patient-controlled analgesia devices, local anesthetic infiltration, and regional anesthesia. Among these techniques, intramuscular and intravenous (IV) injections may be ineffective in pain management, as they are generally administered after the pain has commenced. In addition, intermittent treatment with analgesic agents may not result in a therapeutic level in the blood. The most common analgesic agents used postoperatively are opioids. However, parenteral opioids may result in undesirable adverse events, such as nausea, vomiting, itching, sedation, and respiratory depression. Various methods are available to reduce the use of systemic opioids in postoperative pain management, one of which is local anesthetic infiltration (wound infiltration) into the operation site. Several studies reported that wound infiltration can reduce opioid consumption following surgery. Various regional anesthesia techniques can also be used to manage postoperative pain. Such techniques have a high success rate, especially if they are applied with ultrasound (US) guidance, as US improves visualization, thereby reducing potential complications. Previous research reported that US-guided modified thoracolumbar interfacial plane (mTLIP) block after lumbar spinal surgery via a lateral approach provided effective analgesia. No studies seem to have compared the analgesic effectiveness of wound infiltration versus TLIP block. In this study, the investigators compared the analgesic efficacy of the US-guided mTLIP block and wound infiltration following lumbar disc surgery. The primary aim was to compare postoperative opioid consumption. The secondary aim was to evaluate postoperative pain scores and adverse effects of opioids, such as allergic reactions, nausea, and vomiting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Lumbar spinal surgery, Postoperative pain management, Modified thoracolumbar interfacial plane block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients were aged 18-65 years, American Society of Anesthesiologists classification I-II, and scheduled for lumbar disc surgery under general anesthesia. The patients were randomly divided into two groups using a randomizing computer program: a TLIP block group (group T) and a wound infiltration group (group W), with 30 patients in each group).
Masking
ParticipantOutcomes Assessor
Masking Description
Outcomes Assessor and participant were blinded to the study
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group T = TLIP block group
Arm Type
Active Comparator
Arm Description
After the induction of anesthesia and placement of the patient in a prone position, US-guided mTLIP block was performed via the lateral approach in group T. For postoperative analgesia, a dose of 1 g of paracetamol (IV) was administered routinely, every 8 h. All the patients received fentanyl via a patient-controlled analgesia device. The protocol was a 20 mcg bolus without an infusion dose, 20-min lockout time, and 4-h limit
Arm Title
Group W = Wound infiltration group
Arm Type
Active Comparator
Arm Description
After the induction of anesthesia and placement of the patient in a prone position wound infiltration was performed in group W. For postoperative analgesia, a dose of 1 g of paracetamol (IV) was administered routinely, every 8 h. All the patients received fentanyl via a patient-controlled analgesia device. The protocol was a 20 mcg bolus without an infusion dose, 20-min lockout time, and 4-h limit
Intervention Type
Other
Intervention Name(s)
TLIP block group (group T)
Intervention Description
In group T, the block was performed bilaterally under aseptic conditions using the US device with a high-frequency 12-MHz linear US probe. The probe was covered with a sterile sheath and placed vertically at the L3 vertebrae level. After visualizing the hyperechoic shadow of the spinous process and interspinous muscles as an anatomical guide point, the probe was moved forward in a lateral direction to visualize the longissimus and iliocostal muscles. Using the in-plane technique, a 22-G, 50-mm block needle was inserted between the muscles in a medial-to-lateral direction in the interfascial plane. Once the needle tip was placed within the interfacial plane and after careful aspiration to rule out intravascular needle placement, 2 ml of saline was injected to confirm the accuracy of the injection site. A dose of 0.25% bupivacaine (20 ml) was then injected in each side (total 40 ml).
Intervention Type
Other
Intervention Name(s)
Wound infiltration group (group W)
Intervention Description
In group W, a dose of 0.5% bupivacaine (20 ml) was injected for wound infiltration into the surgery site.
Primary Outcome Measure Information:
Title
Opioid consumption by the patients at postoperative 24 hours period
Description
Fentanyl using
Time Frame
Postoperative 24 hours
Secondary Outcome Measure Information:
Title
Postoperative pain scores
Description
Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 0, 2, 4, 8, 16 and 24 hours.
Time Frame
Postoperative 24 hours period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) classification I-II Scheduled for lumbar discectomy/hemilaminectomy surgery under general anesthesia Exclusion Criteria: Bleeding diathesis Receiving anticoagulant treatment Known local anesthetics and opioid allergy Infection of the skin at the site of the needle puncture Pregnancy or lactation Patients who do not accept the procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahadir Ciftci, Asist.Prof
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
State/Province
Bagcilar
ZIP/Postal Code
34070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will not be shared
Citations:
PubMed Identifier
28625449
Citation
Ahiskalioglu A, Yayik AM, Alici HA. Ultrasound-guided lateral thoracolumbar interfascial plane (TLIP) block: Description of new modified technique. J Clin Anesth. 2017 Aug;40:62. doi: 10.1016/j.jclinane.2017.04.015. No abstract available.
Results Reference
background
PubMed Identifier
28243853
Citation
Ahiskalioglu A, Alici HA, Selvitopi K, Yayik AM. Ultrasonography-guided modified thoracolumbar interfascial plane block: a new approach. Can J Anaesth. 2017 Jul;64(7):775-776. doi: 10.1007/s12630-017-0851-y. Epub 2017 Feb 27. No abstract available.
Results Reference
background
PubMed Identifier
18425538
Citation
Gurbet A, Bekar A, Bilgin H, Korfali G, Yilmazlar S, Tercan M. Pre-emptive infiltration of levobupivacaine is superior to at-closure administration in lumbar laminectomy patients. Eur Spine J. 2008 Sep;17(9):1237-41. doi: 10.1007/s00586-008-0676-z. Epub 2008 Apr 19.
Results Reference
background
PubMed Identifier
22260370
Citation
Kjaergaard M, Moiniche S, Olsen KS. Wound infiltration with local anesthetics for post-operative pain relief in lumbar spine surgery: a systematic review. Acta Anaesthesiol Scand. 2012 Mar;56(3):282-90. doi: 10.1111/j.1399-6576.2011.02629.x. Epub 2012 Jan 19.
Results Reference
background

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An mTLIP Block for Analgesia Management After Lumbar Spinal Surgery.

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