An mTLIP Block for Analgesia Management After Lumbar Spinal Surgery.

Lumbar Disc Herniation Clinical Trial

Official title:

A Comparison of Ultrasound-Guided Modified-Thoracolumbar Interfacial Plane Block and Wound Infiltration for Postoperative Pain Management in Lumbar Spinal Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967314
• Other study ID #: Medipol Hospital
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: April 30, 2019

Study information

• Verified date: May 2019
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Disc Herniation

Intervention

Other:
• TLIP block group (group T)
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).
• Wound infiltration group (group W)
In group W, a dose of 0.5% bupivacaine (20 ml) was injected for wound infiltration into the surgery site.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Hospital	Istanbul	Bagcilar

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Kjærgaard M, Møiniche 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption by the patients at postoperative 24 hours period	Fentanyl using	Postoperative 24 hours
Secondary	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.	Postoperative 24 hours period