Plane Block vs Intravenous Patient Controlled Analgesia

Lumbar Disc Herniation Clinical Trial

Official title:

Randomized Controlled Comparison of the Erector Spina Plane Block and Modified Thoracolumbar Interfacial Plane Block and Intravenous Patient Controlled Analgesia in Patients Undergoing Lumbar Disc Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04457986
• Other study ID #: ESP-MTIP-IVPCA
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: June 2020
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute postoperative pain begins with surgical trauma and decreases with tissue healing. Untreatable postoperative pain is one of the most important problems due to the increase in respiratory, cardiac and thromboembolic complications. Lumber disc surgery is widely performed, and patients often complain of postoperative pain.

Preventing and managing postoperative pain after lumber disc surgery is very important for anesthetists. For this purpose, non-steroidal anti-inflammatory agents, intravenous opioids, preemptive analgesia methods, intravenous patient controlled analgesia methods and regional anesthesia techniques are used within the multimodal analgesia strategy.

Regional anesthesia techniques are becoming increasingly widespread due to their efficiency and increased applicability thanks to the use of ultrasonography. Regional anesthesia techniques used in lumber disc surgery include paravertebral block, local anesthetic infiltration, epidural analgesia, and erector spina plan block and modified thoracolumbar interfacial plan block in recent years.

The erector spina plane block was first described in 2016, and the thoracolumbar interfacial plane block in 2015, and its modification was developed in 2017. Although they vary depending on the level of application, they offer analgesic activity in a wide range. Although there are publications about the use of these blocks for postoperative analgesia after lumber surgeries, which block is more effective has not been investigated.

This study may contribute to the development of new options for pain management after lumber disc surgery by comparing erector spina plane block and modified thoracolumbar interfacial plane block, which have recently been used for postoperative pain treatment, with limited research, with each other and the standard technique, intravenous patient controlled analgesia, can add new applications to multimodal analgesia methods, increase patient satisfaction and contribute to the early recovery process.

The objective is to compare the erector spina plane block and modified thoracolumbar interfacial plane block in patients undergoing lumber disc surgery with intravenous patient-controlled analgesia in terms of analgesic efficacy.

Hypothesis The erector spina plane block and modified thoracolumbar interfacial plane block may decrease the postoperative pain scores, opioid consumption and time to first analgesic requirement compared with intravenous patient controlled analgesia.

Description:

Patients undergoing lumber disc surgery will be randomised into 3 groups. To receive either Erector spina plane block (ESP) or Modified thoracolumbar interfacial plane block (MTI) or Intravenous patient controlled analgesia IV-PCA.

Patients in the ESP and MTI groups will receive the blocks before anesthesia induction in the preoperative holding area.

All patients will receive IV-PCA with tramadol. Postoperative analgesia will be evaluated with a numeric rating scale at postoperative recovery room admittance, postoperative 1st , second, 4th, 12th and 24th hours both at rest and during movement.

Postoperative tramadol consumption and time to first tramadol demand will be determined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients undergoing elective lumber discectomy or laminectomy

• Adults

• Aged 18-65

• America Society of Anesthesiologists physical status I-III

Exclusion Criteria:

• Emergency surgery

• Chronic pain condition

• Allergic to study drugs

• Recurrent surgical cases

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniation

Intervention

Drug:
• Erector spina plane block (ESP)
Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol
• Modified thoracolumbar interfacial plane block (MTI)
Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol
• Intravenous patient controlled analgesia (IV-PCA)
Patient will receive intravenous patient controlled analgesia with tramadol

Locations

Country	Name	City	State
Turkey	Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. — View Citation

Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7. — View Citation

Ueshima H, Hara E, Otake H. Thoracolumbar interfascial plane block provides effective perioperative pain relief for patients undergoing lumbar spinal surgery; a prospective, randomized and double blinded trial. J Clin Anesth. 2019 Dec;58:12-17. doi: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)	10 minutes after extubation
Primary	Pain score	Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)	postoperative 1st hour
Primary	Pain score	Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)	postoperative 2nd hour
Primary	Pain score	Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)	postoperative 4th hour
Primary	Pain score	Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)	postoperative 12th hour
Primary	Pain score	Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)	postoperative 24th hour
Primary	Tramadol consumption	Tramadol consumption will be determined from the ambulatory infusion pump (Abott)	postoperative 24th hour
Primary	Time to first analgesia request	Time to first tramadol request will be determined from the ambulatory infusion pump (Abott)	10 minutes after extubation