Plane Block vs Intravenous Patient Controlled Analgesia

NCT ID: NCT04457986

Last Updated: 2020-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2020-10-01

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.

Conditions

Lumbar Disc Herniation

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Erector spina plane block (ESP)

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

Group Type: EXPERIMENTAL

Erector spina plane block (ESP)

Intervention Type: DRUG

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

Modified thoracolumbar interfacial plane block (MTI)

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

Group Type: EXPERIMENTAL

Modified thoracolumbar interfacial plane block (MTI)

Intervention Type: DRUG

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

Intravenous patient controlled analgesia (IV-PCA)

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

Group Type: ACTIVE_COMPARATOR

Intravenous patient controlled analgesia (IV-PCA)

Intervention Type: DRUG

Patient will receive intravenous patient controlled analgesia with tramadol

Interventions

Erector spina plane block (ESP)

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

Intervention Type: DRUG

Modified thoracolumbar interfacial plane block (MTI)

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

Intervention Type: DRUG

Intravenous patient controlled analgesia (IV-PCA)

Patient will receive intravenous patient controlled analgesia with tramadol

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

DILEK YAZICIOGLU

Assoc Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ÜNAL Dr YAZICIOĞLU, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

DISKAPI YILDIRIM BEYAZIT TEACHING HOSPITAL

Locations

Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 27501016 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26149600 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31029989 (View on PubMed)

Other Identifiers

ESP-MTIP-IVPCA

Identifier Type: -

Identifier Source: org_study_id