Plane Block vs Intravenous Patient Controlled Analgesia

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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Drug: Erector spina plane block (ESP); Drug: Modified thoracolumbar interfacial plane block (MTI); Drug: Intravenous patient controlled analgesia (IV-PCA)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06110
    • Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erector spina plane block (ESP); Patients will receive Erector spina plane block (ESP) with bupivacaine for postoperative analgesia	Drug: Erector spina plane block (ESP); Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol
Experimental: Modified thoracolumbar interfacial plane block (MTI); Patients will receive Modified thoracolumbar interfacial plane block (MTI) with bupivacaine for postoperative analgesia	Drug: Modified thoracolumbar interfacial plane block (MTI); Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol
Active Comparator: Intravenous patient controlled analgesia (IV-PCA); Patients will receive Intravenous patient controlled analgesia (IV-PCA) with tramadol for postoperative analgesia	Drug: Intravenous patient controlled analgesia (IV-PCA); Patient will receive intravenous patient controlled analgesia with tramadol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Investigators: Principal Investigator: ÜNAL Dr YAZICIOĞLU, Assoc Prof, DISKAPI YILDIRIM BEYAZIT TEACHING HOSPITAL

Publications and helpful links

General Publications

• 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.
• 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.
• Ueshima H, Hara E, Otake H. RETRACTED: 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: 10.1016/j.jclinane.2019.04.026. Epub 2019 Apr 25.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: postoperative pain; patient controlled analgesia; erector spina plane block; thoracolumbar interfacial plane block
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: ESP-MTIP-IVPCA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No