Ultrasound-guided Block for Thoracic Surgery Pain

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03240562

Collaborator

(none)

Enrollment

Location

Arms

4.9

Actual Duration (Months)

18.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Thoracic Cancer	Procedure: serratus anterior plane block Drug: patient controlled analgesia	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

89 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Ultrasound-guided Serratus Anterior Plane Block for Thoracic Surgery Pain?

Actual Study Start Date :

Aug 3, 2017

Actual Primary Completion Date :

Nov 30, 2017

Actual Study Completion Date :

Dec 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: IV-PCA group no block performing, only use intravenous patient controled analgesia(IV-PCA)	Drug: patient controlled analgesia two groups have same intravenous patient controlled analgesia
Experimental: SAPB group serratus anterior plane block(SAPB) and intravenous patient controled analgesia(IV-PCA)	Procedure: serratus anterior plane block before surgery :ultrasound-guided serratus anterior plane block Drug: patient controlled analgesia two groups have same intravenous patient controlled analgesia

Arm

Intervention/Treatment

Sham Comparator: IV-PCA group

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

Drug: patient controlled analgesia

two groups have same intravenous patient controlled analgesia

Experimental: SAPB group

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

Procedure: serratus anterior plane block

before surgery :ultrasound-guided serratus anterior plane block

Drug: patient controlled analgesia

two groups have same intravenous patient controlled analgesia

Outcome Measures

Primary Outcome Measures

opioid consumption [the first 24hour in postoperative phase]
the dose of PCA and residual opioid

Secondary Outcome Measures

postoperative pain scale [intraoperative(immediately after surgery), postoperative 6 ,12, 24 hour]
numeric rating scale
opioid consumption [the first 6,12 hour in postoperative phase]
the dose of PCA and residual opioid

Other Outcome Measures

questionnaire about patient's satisfaction for pain management [postoperative 24 hour]
score 1(bad)-5(good)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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