Postoperative PainNCT03240562
Ultrasound-guided Block for Thoracic Surgery Pain
A study testing serratus anterior plane block in people with Postoperative Pain and Thoracic Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigators aimed to assess Ultrasounde- guided serratus anterior plane block can be effective in acute postoperative pain following thoracic surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Postoperative Pain, Thoracic Cancer
- What is being tested?
- serratus anterior plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Aug 2017to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •undergoing thoracic surgery (lobectomy or segmentectomy)
Who cannot join
- allergy to any drugs chronic pain disease with medication psychologic disorder anti-depressant drug chronic kidney disease ( Cr over 2.0 mg/dl) coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Serratus Anterior Plane Block for Thoracic Surgery Pain?
The investigators aimed to assess Ultrasounde- guided serratus anterior plane block can be effective in acute postoperative pain following thoracic surgery.
Read the 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.
- Conditions
- Postoperative Pain, Thoracic Cancer
- Being tested
- serratus anterior plane block, patient controlled analgesia
- Keywords
- serratus anterior plane block, ultrasound-guided, regional anesthesia, thoracic surgery, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serratus anterior plane blockProcedure or surgery
before surgery :ultrasound-guided serratus anterior plane block
patient controlled analgesiaDrug
two groups have same intravenous patient controlled analgesia
| Study group | Role | What they receive |
|---|---|---|
| IV-PCA group | Sham comparator | no block performing, only use intravenous patient controled analgesia(IV-PCA) Receives: Drug: patient controlled analgesia |
| SAPB group | Experimental | serratus anterior plane block(SAPB) and intravenous patient controled analgesia(IV-PCA) Receives: Procedure: serratus anterior plane block; Drug: patient controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption
the dose of PCA and residual opioid
Measured: the first 24hour in postoperative phase
Secondary outcomes (2)
postoperative pain scale
numeric rating scale
Measured: intraoperative(immediately after surgery), postoperative 6 ,12, 24 hour
opioid consumption
the dose of PCA and residual opioid
Measured: the first 6,12 hour in postoperative phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start3 Aug 2017
- Primary completion30 Nov 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240562
- Sponsor's protocol ID
- SMC2017-06-123
- Status last verified
- Jul 2017
- First submitted
- 28 Jul 2017
- Last updated
- 28 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28614112Duceau 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.
PubMed 28489642Liu 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.
PubMed 28679359Terkawi 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.
PubMed 26431130Wildgaard 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.
PubMed 22219442Madabushi 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.
PubMed 26000690
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Serratus Anterior Plane Block for Thoracic Surgery Pain?
- ClinicalTrials.gov ID
- NCT03240562
- Acronym / sponsor ID
- SMC2017-06-123
- Conditions
- Postoperative Pain, Thoracic Cancer
- Keywords
- serratus anterior plane block, ultrasound-guided, regional anesthesia, thoracic surgery, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV-PCA group | Sham comparator | Drug: patient controlled analgesiano block performing, only use intravenous patient controled analgesia(IV-PCA) |
| SAPB group | Experimental | Procedure: serratus anterior plane block, Drug: patient controlled analgesiaserratus anterior plane block(SAPB) and intravenous patient controled analgesia(IV-PCA) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •undergoing thoracic surgery (lobectomy or segmentectomy)
Key exclusion criteria (1 listed)
- allergy to any drugs chronic pain disease with medication psychologic disorder anti-depressant drug chronic kidney disease ( Cr over 2.0 mg/dl) coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serratus anterior plane blockbefore surgery :ultrasound-guided serratus anterior plane block | Procedure or surgery | SAPB group |
| patient controlled analgesiatwo groups have same intravenous patient controlled analgesia | Drug | IV-PCA group, SAPB group |
Primary outcome
opioid consumption
Time frame: the first 24hour in postoperative phase
the dose of PCA and residual opioid
2 secondary outcomes
postoperative pain scale
Time frame: intraoperative(immediately after surgery), postoperative 6 ,12, 24 hour
opioid consumption
Time frame: the first 6,12 hour in postoperative phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Background: PubMed 28614112Chu 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.
- Background: PubMed 28489642Duceau 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.
- Background: PubMed 28679359Liu 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.
- Background: PubMed 26431130Terkawi 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.
- Background: PubMed 22219442Wildgaard 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.
- Background: PubMed 26000690Madabushi 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.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serratus anterior plane block in people with Postoperative Pain and Thoracic Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid consumption (time frame: the first 24hour in postoperative phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03240562, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.