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Ultrasound-guided Block for Thoracic Surgery Pain

Primary Purpose

Postoperative Pain, Thoracic Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
serratus anterior plane block
patient controlled analgesia
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring serratus anterior plane block, ultrasound-guided, regional anesthesia, thoracic surgery, postoperative pain

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

•undergoing thoracic surgery (lobectomy or segmentectomy)

Exclusion Criteria:

• allergy to any drugs chronic pain disease with medication psychologic disorder anti-depressant drug chronic kidney disease ( Cr over 2.0 mg/dl) coagulopathy

Sites / Locations

  • Samsung medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

IV-PCA group

SAPB group

Arm Description

no block performing, only use intravenous patient controled analgesia(IV-PCA)

serratus anterior plane block(SAPB) and intravenous patient controled analgesia(IV-PCA)

Outcomes

Primary Outcome Measures

opioid consumption
the dose of PCA and residual opioid

Secondary Outcome Measures

postoperative pain scale
numeric rating scale
opioid consumption
the dose of PCA and residual opioid

Full Information

First Posted
July 28, 2017
Last Updated
February 26, 2018
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03240562
Brief Title
Ultrasound-guided Block for Thoracic Surgery Pain
Official Title
Ultrasound-guided Serratus Anterior Plane Block for Thoracic Surgery Pain?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 3, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

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
The investigators aimed to assess Ultrasounde- guided serratus anterior plane block can be effective in acute postoperative pain following thoracic surgery.
Detailed Description
Analgesic options for thoracotomy are various with each having their own merits and demerits.Thoracic epidural is said to be the gold standard for management of thoracotomy pain. However, it is invasive procedure and many side effects. Other options include paravertebral block, interpleural block, intrathecal opioids. Especially, paravertebral block is thought good alternative to epidural anethesia. Most of these invasive neuraxial techniques demand normal coagulation parameters to be present. The serratus anterior plane block(SAPB) was done under ultrasound guidance in the mid-axillary line at the level of the fourth rib and the catheter was placed superficial to the serratus plane. The patient expressed relief in pain within 10 minutes of being given the bolus of local anaesthetic.Pain following thoracotomy is chiefly due to rib retraction, and damage to the serratus/intercostal muscles and intercostal nerves. A SAPB addresses both these aspects. SAPB has been mentioned in previous studies for management of rib fractures and breast surgeries. The investigators try to evaluate whether the SAPB is easy to perform and provides effective analgesia in patients undergoing thoracotomy with minimal side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Thoracic Cancer
Keywords
serratus anterior plane block, ultrasound-guided, regional anesthesia, thoracic surgery, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV-PCA group
Arm Type
Sham Comparator
Arm Description
no block performing, only use intravenous patient controled analgesia(IV-PCA)
Arm Title
SAPB group
Arm Type
Experimental
Arm Description
serratus anterior plane block(SAPB) and intravenous patient controled analgesia(IV-PCA)
Intervention Type
Procedure
Intervention Name(s)
serratus anterior plane block
Intervention Description
before surgery :ultrasound-guided serratus anterior plane block
Intervention Type
Drug
Intervention Name(s)
patient controlled analgesia
Intervention Description
two groups have same intravenous patient controlled analgesia
Primary Outcome Measure Information:
Title
opioid consumption
Description
the dose of PCA and residual opioid
Time Frame
the first 24hour in postoperative phase
Secondary Outcome Measure Information:
Title
postoperative pain scale
Description
numeric rating scale
Time Frame
intraoperative(immediately after surgery), postoperative 6 ,12, 24 hour
Title
opioid consumption
Description
the dose of PCA and residual opioid
Time Frame
the first 6,12 hour in postoperative phase
Other Pre-specified Outcome Measures:
Title
questionnaire about patient's satisfaction for pain management
Description
score 1(bad)-5(good)
Time Frame
postoperative 24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: •undergoing thoracic surgery (lobectomy or segmentectomy) Exclusion Criteria: • allergy to any drugs chronic pain disease with medication psychologic disorder anti-depressant drug chronic kidney disease ( Cr over 2.0 mg/dl) coagulopathy
Facility Information:
Facility Name
Samsung medical center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28614112
Citation
Chu GM, Jarvis GC. Serratus Anterior Plane Block to Address Postthoracotomy and Chest Tube-Related Pain: A Report on 3 Cases. A A Case Rep. 2017 Jun 15;8(12):322-325. doi: 10.1213/XAA.0000000000000502.
Results Reference
background
PubMed Identifier
28489642
Citation
Duceau B, Baubillier M, Bouroche G, Albi-Feldzer A, Jayr C. Pupillary Reflex for Evaluation of Thoracic Paravertebral Block: A Prospective Observational Feasibility Study. Anesth Analg. 2017 Oct;125(4):1342-1347. doi: 10.1213/ANE.0000000000002003.
Results Reference
background
PubMed Identifier
28679359
Citation
Liu F, Zhang H, Zuo Y. Bilateral thoracic Paravertebral block for immediate postoperative pain relief in the PACU: a prospective, observational study. BMC Anesthesiol. 2017 Jul 5;17(1):89. doi: 10.1186/s12871-017-0378-3.
Results Reference
background
PubMed Identifier
26431130
Citation
Terkawi AS, Tsang S, Sessler DI, Terkawi RS, Nunemaker MS, Durieux ME, Shilling A. Improving Analgesic Efficacy and Safety of Thoracic Paravertebral Block for Breast Surgery: A Mixed-Effects Meta-Analysis. Pain Physician. 2015 Sep-Oct;18(5):E757-80.
Results Reference
background
PubMed Identifier
22219442
Citation
Wildgaard K, Petersen RH, Hansen HJ, Moller-Sorensen H, Ringsted TK, Kehlet H. Multimodal analgesic treatment in video-assisted thoracic surgery lobectomy using an intraoperative intercostal catheter. Eur J Cardiothorac Surg. 2012 May;41(5):1072-7. doi: 10.1093/ejcts/ezr151. Epub 2011 Dec 21.
Results Reference
background
PubMed Identifier
26000690
Citation
Madabushi R, Tewari S, Gautam SK, Agarwal A, Agarwal A. Serratus anterior plane block: a new analgesic technique for post-thoracotomy pain. Pain Physician. 2015 May-Jun;18(3):E421-4.
Results Reference
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Ultrasound-guided Block for Thoracic Surgery Pain

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