Plane Block vs Intravenous Patient Controlled Analgesia

NCT04457986 | Completed Phase 4

• 1 other identifier: ESP-MTIP-IVPCA
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbar Disc Herniation

Keywords

postoperative pain; erector spina plane block; thoracolumbar interfacial plane block; patient controlled analgesia

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

Erector spina plane block (ESP)

EXPERIMENTAL

Patients will receive Erector spina plane block (ESP) with bupivacaine for postoperative analgesia

Drug: Erector spina plane block (ESP)

Modified thoracolumbar interfacial plane block (MTI)

EXPERIMENTAL

Patients will receive Modified thoracolumbar interfacial plane block (MTI) with bupivacaine for postoperative analgesia

Drug: Modified thoracolumbar interfacial plane block (MTI)

Intravenous patient controlled analgesia (IV-PCA)

ACTIVE COMPARATOR

Patients will receive Intravenous patient controlled analgesia (IV-PCA) with tramadol for postoperative analgesia

Drug: Intravenous patient controlled analgesia (IV-PCA)

Interventions

Erector spina plane block (ESP) DRUG

Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol

Erector spina plane block (ESP)

Modified thoracolumbar interfacial plane block (MTI) DRUG

Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol

Modified thoracolumbar interfacial plane block (MTI)

Intravenous patient controlled analgesia (IV-PCA) DRUG

Patient will receive intravenous patient controlled analgesia with tramadol

Intravenous patient controlled analgesia (IV-PCA)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective lumber discectomy or laminectomy
• Adults
• Aged 18-65
• America Society of Anesthesiologists physical status I-III

You may not qualify if:

• Emergency surgery
• Chronic pain condition
• Allergic to study drugs
• Recurrent surgical cases

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

Related 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 26149600 BACKGROUND

• 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.

  PMID: 31029989 RESULT

MeSH Terms

Conditions

Intervertebral Disc Displacement; Pain, Postoperative

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• ÜNAL Dr YAZICIOĞLU, Assoc Prof

  DISKAPI YILDIRIM BEYAZIT TEACHING HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Postoperative pain will be assessed by an anaesthesiologist unaware of group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Professor

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 7, 2020
• Study Start: July 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)