An mTLIP Block for Analgesia Management After Lumbar Spinal Surgery.

NCT03967314 | Completed

• 1 other identifier: Medipol Hospital
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation

Keywords

Lumbar spinal surgery; Postoperative pain management; Modified thoracolumbar interfacial plane block

Outcome Measures

Primary Outcomes (1)

• Opioid consumption by the patients at postoperative 24 hours period

  Fentanyl using

  Postoperative 24 hours

Secondary Outcomes (1)

• Postoperative pain scores

  Postoperative 24 hours period

Study Arms (2)

Group T = TLIP block group

ACTIVE COMPARATOR

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

Other: TLIP block group (group T)

Group W = Wound infiltration group

ACTIVE COMPARATOR

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

Other: Wound infiltration group (group W)

Interventions

TLIP block group (group T) OTHER

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).

Group T = TLIP block group

Wound infiltration group (group W) OTHER

In group W, a dose of 0.5% bupivacaine (20 ml) was injected for wound infiltration into the surgery site.

Group W = Wound infiltration group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 28625449 BACKGROUND

• 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.

  PMID: 28243853 BACKGROUND

• 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.

  PMID: 18425538 BACKGROUND

• 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.

  PMID: 22260370 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Sensitivity Training Groups

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Bahadir Ciftci, Asist.Prof

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor and participant were blinded to the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary researcher

Model Details: 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).

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 30, 2019
• Study Start: January 1, 2019
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)