Trials / Completed
CompletedNCT03967314
An mTLIP Block for Analgesia Management After Lumbar Spinal Surgery.
A Comparison of Ultrasound-Guided Modified-Thoracolumbar Interfacial Plane Block and Wound Infiltration for Postoperative Pain Management in Lumbar Spinal Surgery Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Medipol University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
| OTHER | 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. |
Timeline
- Start date
- 2019-01-01
- Primary completion
- 2019-04-30
- Completion
- 2019-04-30
- First posted
- 2019-05-30
- Last updated
- 2019-05-30
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT03967314. Inclusion in this directory is not an endorsement.