An mTLIP Block for Analgesia Management After Lumbar Spinal Surgery.

Not Applicable

Completed

• Conditions: Lumbar Disc Herniation
• Interventions: Other: TLIP block group (group T); Other: Wound infiltration group (group W)

• Registration Number: NCT03967314
• Lead Sponsor: Medipol University

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2019-05
• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-27
• Last Update Submitted: 2019-05-27
• Study First Posted: 2019-05-30
• Last Update Posted: 2019-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group T = TLIP block group	TLIP block group (group T)	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
Group W = Wound infiltration group	Wound infiltration group (group W)	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

Primary Outcome Measures

Name	Time	Method
Opioid consumption by the patients at postoperative 24 hours period	Postoperative 24 hours	Fentanyl using

Secondary Outcome Measures

Name	Time	Method
Postoperative pain scores	Postoperative 24 hours period	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.

Trial Locations

Locations (1)

Istanbul Medipol University Hospital; 🇹🇷 Istanbul, Bagcilar, Turkey