Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery

NCT04193488 | Completed

• 1 other identifier: 19/342
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Ethics committee approval was taken on October 22, 2019, numbered 19/342. 120 adult patients who will undergo spine stabilization surgery between October 2019 and January 2020 in "Gülhane Training and Research Hospital" were planned to be included in the study. Patients will be randomized to 30 patients with MTP block (Group MTP) and ESP block (Group ESP) and no block (Group K) in addition to patient-controlled analgesia (PCA). Postoperative pain scores, analgesic use, number of PCA button presses, total amount of opioid administered and complications due to opioids will be recorded. The obtained data will be compared statistically.

Conditions

Postoperative Pain; Anesthesia, Regional; Spinal Stenosis

Keywords

spinal surgery; Erector spina plan block; Mid-transverse process to pleura block; post-operative analgesia

Outcome Measures

Primary Outcomes (4)

• numeric rating scale (NRS)

  Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS) was assessed using three days after surgery

  three days postoperatively

• use of patient control analgesia

  The number of PCA button presses, the total amount of opioids applied

  three days postoperatively

• complications related to opioids

  Nausea, Vomiting, Itching, Constipation, Difficulty in urination, Difficulty in Concentration, Drowsiness or difficulty staying awake, Feeling of light dizziness, Feeling of dizziness, Feelings of general fatigue or weakness, Dry mouth, Headache

  three days postoperatively

• Additional analgesic use

  Additional analgesic dexketoprofen (trometamol) 50 mg / 2 ml will be administered to patients with an NRS score\> 3 and the amount of use will be recorded.analgesics

  three days postoperatively

Study Arms (3)

MTP block (Group MTP)

ACTIVE COMPARATOR

In the MTP Group, a high frequency HFL-50 15-6 MHz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Using the parasaggital scan, the block needle (50 mm 22 Gauge will be advanced from the caudal to the cervical target of the paravertebral space. When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml normal saline is performed. Once the needle tip has been confirmed, 20 ml of 0.25% bupivacaine will be given to the block. The same procedure will be applied 3 cm later than the incision line.

Behavioral: MTP block

ESP block (Group ESP)

ACTIVE COMPARATOR

In the ESP group, a high-frequency 15-6 megahertz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Once the erector spinae muscle and transver projections have been identified, the peripheral nerve blockage needle (50 mm 22 Gauge) will be advanced from caudal to cranial between the fascia of the erector spina muscle and the transverse process. After 1 ml normal saline injection, this plane will open. Twenty milliliters of 0.25% bupivacaine will be given for the block. The same procedure will be applied from the other 3 cm lateral of the incision line.

Behavioral: ESP block

no block (Group C)

ACTIVE COMPARATOR

No regional plan block will be applied to the control group. Conventional analgesic methods were applied.

Behavioral: No Block group

Interventions

MTP block BEHAVIORAL

In the MTP Group, a high frequency HFL-50 15-6 MHz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Using the parasagital scan, the block needle (50 mm 22 Gauge) will be advanced from the caudal to the cervical target of the paravertebral space. When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml saline is performed. Once the needle tip has been confirmed, 20 ml of 0.25% bupivacaine will be given to the block. The same procedure will be applied 3 cm later than the incision line.

MTP block (Group MTP)

ESP block BEHAVIORAL

In the ESP group, a high-frequency 15-6 megahertz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Once the erector spinae muscle and transver projections have been identified, the peripheral nerve blockage needle (50 mm 22 Gauge) will be advanced from caudal to cranial between the fascia of the erector spina muscle and the transverse process. After 1 ml saline injection, this plane will open. Twenty milliliters of 0.25% bupivacaine will be given for the block. The same procedure will be applied from the other 3 cm lateral of the incision line.

ESP block (Group ESP)

No Block group BEHAVIORAL

No regional plan block will be applied to the control group. Conventional analgesic methods were applied.

no block (Group C)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• ASA (American Society of Anesthesiologists) score between I-III.

You may not qualify if:

• ASA (American Society of Anesthesiologists) score \>III,
• emergency surgery,
• secondary surgery,
• receiving chronic pain treatment

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, Keçiören, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Spinal Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Mehmet B EŞKİN

  Gulhane Training and Research Hospital

  STUDY DIRECTOR

• Ayşegül Ceylan

  Gulhane Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients will be randomized to 30 patients with MTP block (Group MTP) and 30 patients with ESP block (Group ESP) and 30 patients with no block (Group K) in addition to patient-controlled analgesia (PCA).

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 10, 2019
• Study Start: October 23, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 15, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

TU (1)