NCT03240562

Brief Summary

The investigators aimed to assess Ultrasounde- guided serratus anterior plane block can be effective in acute postoperative pain following thoracic surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

August 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

February 28, 2018

Status Verified

July 1, 2017

Enrollment Period

4 months

First QC Date

July 28, 2017

Last Update Submit

February 26, 2018

Conditions

Postoperative PainThoracic Cancer

Keywords

serratus anterior plane blockultrasound-guidedregional anesthesiathoracic surgerypostoperative pain

Outcome Measures

Primary Outcomes (1)

  • opioid consumption

    the dose of PCA and residual opioid

    the first 24hour in postoperative phase

Secondary Outcomes (2)

  • postoperative pain scale

    intraoperative(immediately after surgery), postoperative 6 ,12, 24 hour

  • opioid consumption

    the first 6,12 hour in postoperative phase

Other Outcomes (1)

  • questionnaire about patient's satisfaction for pain management

    postoperative 24 hour

Study Arms (2)

IV-PCA group

SHAM COMPARATOR

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

Drug: patient controlled analgesia

SAPB group

EXPERIMENTAL

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

Procedure: serratus anterior plane blockDrug: patient controlled analgesia

Interventions

serratus anterior plane blockPROCEDURE

before surgery :ultrasound-guided serratus anterior plane block

SAPB group
patient controlled analgesiaDRUG

two groups have same intravenous patient controlled analgesia

IV-PCA groupSAPB group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing thoracic surgery (lobectomy or segmentectomy)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung medical center

Seoul, 06351, South Korea

Location

Related Publications (6)

  • 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.

    PMID: 28614112BACKGROUND

  • 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.

    PMID: 28489642BACKGROUND

  • 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.

    PMID: 28679359BACKGROUND

  • 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.

    PMID: 26431130BACKGROUND

  • 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.

    PMID: 22219442BACKGROUND

  • 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.

    PMID: 26000690BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 7, 2017

Study Start

August 3, 2017

Primary Completion

November 30, 2017

Study Completion

December 30, 2017

Last Updated

February 28, 2018

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)