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The Effect of Ultrasound-guided Erector Spinae Block and Intraoperative Intercostal Nerve Block on Postoperative Analgesia in Thoracic Surgery

Primary Purpose

Anesthesia, Postoperative Pain, Ultrasound Therapy; Complications

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Intrathoracic Intercostal Nerve Block
Erector Spinae Plane Block
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia focused on measuring Erector Spinae Plane Block, ESPB, Intercostal Nerve Block, ICNB, Thoracic surgery, Postoperative pain, Quality of recovery

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient receive thoracic surgery
  • BMI between 18.5~30.0 kg.m-2

Exclusion Criteria:

  • Pregnant woman
  • Patient with any one of following chronic organ dysfunction: Heart failure (NYHA score =III、IV); Renal failure (eGFR< 60 ml.min-1.1.73m-2)
  • Arrhythmia
  • Ongoing infection or septic patient
  • Chronic use of analgesic with addiction
  • Coagulopathy that is not suitable for regional anesthesia performance
  • Thoracic surgery that is not suitable for placement of endotracheal blocker tube
  • Redo surgery

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ICNB group

ESPB group

Arm Description

After patient was turned to lateral decubitus position, local anesthetics is injected around incision site and ICNB is performed once after surgeon geys into chest cavity.

After patient was turned to lateral decubitus position, ESPB is performed via ultrasound guided technique before sound incision.

Outcomes

Primary Outcome Measures

Pain intensity
Pain intensities in two category, namely static and dynamic, gauged by a 0-100 mm visual analogue scale, (no pain to severe pain)
Postoperative analgesic consumption
Cumulative morphine consumption in postoperative two days

Secondary Outcome Measures

Recovery quality: questionnaire
Postoperative recovery quality assessed by Quality of recovery-15 (QoR-15) questionnaire, with a score range of 0-150, (poor recovery to excellent recovery)

Full Information

First Posted
October 5, 2020
Last Updated
May 4, 2023
Sponsor
National Taiwan University Hospital
Collaborators
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT04581616
Brief Title
The Effect of Ultrasound-guided Erector Spinae Block and Intraoperative Intercostal Nerve Block on Postoperative Analgesia in Thoracic Surgery
Official Title
The Effect of Ultrasound-guided Erector Spinae Block and Intraoperative Intercostal Nerve Block on Postoperative Analgesia in Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 16, 2020 (Actual)
Primary Completion Date
October 16, 2022 (Actual)
Study Completion Date
October 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Taipei Veterans General Hospital, Taiwan

4. Oversight

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

5. Study Description

Brief Summary
This study aims to compare the effect of ultrasound-guided erector spinae plane block and interthoracic intercostal nerve block in thoracic surgery. Interthoracic intercostal nerve block is a routine procedure during the surgery by the surgeon in our hospital, and ultrasound-guide erector spinae plane block is a relative new developed regional analgesia technique introduced since 2016 and mainly done by anesthesiologists. Both technique provide analgesic effect to some extent and reduce opiate consumption and side effects. However, no previous literature or research compare the effect of these two technique in thoracic surgery. The primary endpoint of our study is compare morphine consumption and pain score between patients undergo ESP block and patients undergo ICNB after thoracic surgery; the second endpoint is to compare the recovery condition evaluated by QoR-15 questionaire 24 hours after surgery.
Detailed Description
Sample size estimation is based on our APS team data, in which the average cumulative morphine consumption in patients underwent VATS surgery with ICNB was calculated. The mean cumulative morphine consumption was 15±8 mg of patients underwent VATS with ICNB. We assume the difference between ICNB and ESPB group reach 5 mg and aim for a power of 95 % and a risk of 0.05 for a type-1 error, at least 42 for each group needing to be recruited. 50 patients for each group, total 100 patients will be collected to avoid dropouts. Patient will be allocated to one of the trial groups using a computer-generated random number table once the consent was approved. First group is ICNB group and the second group is ESPB group. The general anesthesia agents, induction process and routine care are the same for both groups. Once aforementioned routine cares are done, the patient will be turn into lateral decubitus position. Echo-guided ESP block will be performed after patients are turned into lateral decubitus position in ESP group; on the other side, local anesthetics will be injected at incision site and intrathoracic intercostal nerve block will be performed in ICNB group right after the surgeon makes the incision site and get into chest cavity. Pain score (VAS) and cumulative morphine consumption will be recorded in PACU, postoperative 24H, 48H, and before discharge. Recovery condition will be evaluated via QoR-15 questionnaire in postoperative 24H, furthermore, we will follow up the patient's pain and recovery status 3 months after the operation. After collecting above data, the effect of ESP group and ICNB group on acute pain relieve, chronic pain control and recovery enhancement will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Postoperative Pain, Ultrasound Therapy; Complications
Keywords
Erector Spinae Plane Block, ESPB, Intercostal Nerve Block, ICNB, Thoracic surgery, Postoperative pain, Quality of recovery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICNB group
Arm Type
Active Comparator
Arm Description
After patient was turned to lateral decubitus position, local anesthetics is injected around incision site and ICNB is performed once after surgeon geys into chest cavity.
Arm Title
ESPB group
Arm Type
Experimental
Arm Description
After patient was turned to lateral decubitus position, ESPB is performed via ultrasound guided technique before sound incision.
Intervention Type
Procedure
Intervention Name(s)
Intrathoracic Intercostal Nerve Block
Other Intervention Name(s)
ICNB
Intervention Description
Injection of local anesthetic into the subcostal groove, to achieve analgesia for chest region.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Other Intervention Name(s)
ESPB
Intervention Description
Injection of local anesthetic in the plane deep to the erector spinae muscles and superficial to the transverse processes, to achieve analgesia for chest region.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensities in two category, namely static and dynamic, gauged by a 0-100 mm visual analogue scale, (no pain to severe pain)
Time Frame
Postoperative 48 hours
Title
Postoperative analgesic consumption
Description
Cumulative morphine consumption in postoperative two days
Time Frame
Postoperative 48 hours
Secondary Outcome Measure Information:
Title
Recovery quality: questionnaire
Description
Postoperative recovery quality assessed by Quality of recovery-15 (QoR-15) questionnaire, with a score range of 0-150, (poor recovery to excellent recovery)
Time Frame
Postoperative 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient receive thoracic surgery BMI between 18.5~30.0 kg.m-2 Exclusion Criteria: Pregnant woman Patient with any one of following chronic organ dysfunction: Heart failure (NYHA score =III、IV); Renal failure (eGFR< 60 ml.min-1.1.73m-2) Arrhythmia Ongoing infection or septic patient Chronic use of analgesic with addiction Coagulopathy that is not suitable for regional anesthesia performance Thoracic surgery that is not suitable for placement of endotracheal blocker tube Redo surgery
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

The Effect of Ultrasound-guided Erector Spinae Block and Intraoperative Intercostal Nerve Block on Postoperative Analgesia in Thoracic Surgery

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