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Plane Block vs Intravenous Patient Controlled Analgesia

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Erector spina plane block (ESP)
Modified thoracolumbar interfacial plane block (MTI)
Intravenous patient controlled analgesia (IV-PCA)
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring postoperative pain, erector spina plane block, thoracolumbar interfacial plane block, patient controlled analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Erector spina plane block (ESP)

Modified thoracolumbar interfacial plane block (MTI)

Intravenous patient controlled analgesia (IV-PCA)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Pain score
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Pain score
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Pain score
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Pain score
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Pain score
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Pain score
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Tramadol consumption
Tramadol consumption will be determined from the ambulatory infusion pump (Abott)
Time to first analgesia request
Time to first tramadol request will be determined from the ambulatory infusion pump (Abott)

Secondary Outcome Measures

Full Information

First Posted
June 26, 2020
Last Updated
November 6, 2020
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04457986
Brief Title
Plane Block vs Intravenous Patient Controlled Analgesia
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
postoperative pain, erector spina plane block, thoracolumbar interfacial plane block, patient controlled analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Postoperative pain will be assessed by an anaesthesiologist unaware of group assignment
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erector spina plane block (ESP)
Arm Type
Experimental
Arm Description
Patients will receive Erector spina plane block (ESP) with bupivacaine for postoperative analgesia
Arm Title
Modified thoracolumbar interfacial plane block (MTI)
Arm Type
Experimental
Arm Description
Patients will receive Modified thoracolumbar interfacial plane block (MTI) with bupivacaine for postoperative analgesia
Arm Title
Intravenous patient controlled analgesia (IV-PCA)
Arm Type
Active Comparator
Arm Description
Patients will receive Intravenous patient controlled analgesia (IV-PCA) with tramadol for postoperative analgesia
Intervention Type
Drug
Intervention Name(s)
Erector spina plane block (ESP)
Intervention Description
Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol
Intervention Type
Drug
Intervention Name(s)
Modified thoracolumbar interfacial plane block (MTI)
Intervention Description
Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol
Intervention Type
Drug
Intervention Name(s)
Intravenous patient controlled analgesia (IV-PCA)
Intervention Description
Patient will receive intravenous patient controlled analgesia with tramadol
Primary Outcome Measure Information:
Title
Pain score
Description
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Time Frame
10 minutes after extubation
Title
Pain score
Description
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Time Frame
postoperative 1st hour
Title
Pain score
Description
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Time Frame
postoperative 2nd hour
Title
Pain score
Description
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Time Frame
postoperative 4th hour
Title
Pain score
Description
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Time Frame
postoperative 12th hour
Title
Pain score
Description
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Time Frame
postoperative 24th hour
Title
Tramadol consumption
Description
Tramadol consumption will be determined from the ambulatory infusion pump (Abott)
Time Frame
postoperative 24th hour
Title
Time to first analgesia request
Description
Time to first tramadol request will be determined from the ambulatory infusion pump (Abott)
Time Frame
10 minutes after extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ÜNAL Dr YAZICIOĞLU, Assoc Prof
Organizational Affiliation
DISKAPI YILDIRIM BEYAZIT TEACHING HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27501016
Citation
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.
Results Reference
background
PubMed Identifier
26149600
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.
Results Reference
background
PubMed Identifier
31029989
Citation
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.
Results Reference
result

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Plane Block vs Intravenous Patient Controlled Analgesia

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