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Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy Patients

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

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

Inclusion Criteria:

  • patients aged >18 years
  • American Society of Anesthesiologists Physical Status I or IV scheduled for elective thoracotomy

Exclusion Criteria:

  • Refusal of the patient to provide written consent
  • history of relevant drug allergy
  • age less than 18
  • obesity BMI > 40 kg/m2
  • infection of the skin at the site of needle puncture area
  • coagulopathy
  • Pregnant females

Sites / Locations

  • Banha University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Erector Spinae Plane Block group

Conventional group

Arm Description

The Erector Spinae Plane block will be done as follow,the patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here. All patients will receive general anesthesia as described in conventional group

Nothing will be injected All patients will receive pre-oxygenation with O2 100% for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg and atracurium 0.5 mg/kg will be used for muscle relaxation. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with target of EtCo2≈ 35-40 mmHg, isoflurane 1:1.5 minimum alveolar concentration (MAC), 0.5μg/kg fentanyl will be given intraoperative when either heart rate or Non Invasive Blood Pressure report an increase by more than 20% of the basal records. Anesthesia will be discontinued and tracheal extubation will be done once patient fulfilled the extubation criteria.

Outcomes

Primary Outcome Measures

24 hours morphine consumption
total morphine consumption in both groups will be assessed in the postoperative period

Secondary Outcome Measures

The quality of analgesia based on visual analogue scale (VAS) pain scores.
VAS score will be obtained in the postoperative period at preset time intervals.Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Side effects of opioid usage
Any evidence of opioid-related morbidity or adverse effects eg. nausea,vomiting,pruritus.These effects will be assessed by questionnaire.
Procedural morbidity
Any evidence of procedure-related morbidity

Full Information

First Posted
November 13, 2018
Last Updated
August 16, 2020
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT03749395
Brief Title
Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy Patients
Official Title
Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy Patients : A Prospective, Randomized, Observer-Blind,Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
November 5, 2019 (Actual)
Study Completion Date
November 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

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
aim of this study is to assess and compare between the efficacy of the new U/S guided erector spinae plane block (ESP) and the conventional methods of systemic analgesics in adult patients scheduled for elective thoracotomy surgery.
Detailed Description
Thoracotomy is considered the most painful of surgical procedures and providing effective analgesia is the onus for all anesthetists. Ineffective pain relief impedes deep breathing, coughing, and remobilization culminating in atelectasis and pneumonia.The erector spinae plane (ESP) block is a newly-described technique for treating thoracic pain, and has several advantages that make it an attractive alternative to these more invasive procedures.Ultrasound guided erector spinae (ESP) block is a regional anesthesia technique, recently described by (Forero; et al.) for use in thoracic neuropathic pain. ESP block is reported to lead to analgesic effect on somatic and visceral pain by effecting the ventral rami and rami communicantes that include sympathetic nerve fibers, as LA spreads through the paravertebral space . When performed bilaterally it has been reported to be as effective as thoracic epidural analgesia.ESP block leads to effective postoperative analgesia when performed at T 4-5 level for breast and thoracic surgery. The ESP block , will be performed as follow:The patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two parallel arms. One group will receive erector spinae plane block, and the other will receive nothing.
Masking
Outcomes Assessor
Masking Description
The practitioner and the patient are not blinded.The outcomes assessor will not know which group each patient is in.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erector Spinae Plane Block group
Arm Type
Active Comparator
Arm Description
The Erector Spinae Plane block will be done as follow,the patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here. All patients will receive general anesthesia as described in conventional group
Arm Title
Conventional group
Arm Type
No Intervention
Arm Description
Nothing will be injected All patients will receive pre-oxygenation with O2 100% for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg and atracurium 0.5 mg/kg will be used for muscle relaxation. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with target of EtCo2≈ 35-40 mmHg, isoflurane 1:1.5 minimum alveolar concentration (MAC), 0.5μg/kg fentanyl will be given intraoperative when either heart rate or Non Invasive Blood Pressure report an increase by more than 20% of the basal records. Anesthesia will be discontinued and tracheal extubation will be done once patient fulfilled the extubation criteria.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
The patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here.
Primary Outcome Measure Information:
Title
24 hours morphine consumption
Description
total morphine consumption in both groups will be assessed in the postoperative period
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
The quality of analgesia based on visual analogue scale (VAS) pain scores.
Description
VAS score will be obtained in the postoperative period at preset time intervals.Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Time Frame
every 6 hours for 24 hours
Title
Side effects of opioid usage
Description
Any evidence of opioid-related morbidity or adverse effects eg. nausea,vomiting,pruritus.These effects will be assessed by questionnaire.
Time Frame
2, 6, 12, 24 hours postoperative
Title
Procedural morbidity
Description
Any evidence of procedure-related morbidity
Time Frame
2, 6, 12, 24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients aged >18 years American Society of Anesthesiologists Physical Status I or IV scheduled for elective thoracotomy Exclusion Criteria: Refusal of the patient to provide written consent history of relevant drug allergy age less than 18 obesity BMI > 40 kg/m2 infection of the skin at the site of needle puncture area coagulopathy Pregnant females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
faculty of medicine
Organizational Affiliation
faculty of medicine
Official's Role
Study Director
Facility Information:
Facility Name
Banha University Hospital
City
Banhā
ZIP/Postal Code
13518
Country
Egypt

12. IPD Sharing Statement

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

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Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy Patients

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