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Pain, PostoperativePhase 4NCT04349774

Erector Spinae Plane Block vs Erector Spinae Plane Block With Serratus Anterior Plane Block in Thoracic Surgery

A Phase 4 study testing Treatment Group - ESP block with SAP normal saline in people with Pain, Postoperative, run by Anna Uskova at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This pilot study will prospectively compare continuous Erector Spinae Plane block (ESP) versus combination of continuous Erector Spinae Plane block and single shot Serratus Anterior Plane block for post-operative pain management in subjects undergoing primary thoracic surgery. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Postoperative
What is being tested?
Treatment Group - ESP block with SAP normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Oct 2022to 30 Dec 2023
Phase
Phase 4
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 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients 18-80 years old
  • Primary Unilateral Thoracic Surgery
  • BMI 20 - 36, weight > or = to 50kg
  • Male and Female
  • All races

Who cannot join

  • Patient refusal
  • Inpatient status at time of surgery
  • ASA class > or = 4
  • Bilateral thoracic surgery
  • Pregnancy
  • Non-English speaking or inability to participate in the study
Show all 12Show fewer
  • Patients with coagulopathy or on therapeutic anticoagulation
  • Chronic Steroid Use
  • Narcotic Addiction
  • Patients with contraindication to performing either block - active infection at block site, systemic infection, allergy to local anesthetic medications
  • Patients undergoing second surgery or urgent/emergent surgery
  • Patients weighing <50kg

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pittsburgh Medical Center (UPMC) Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: A Prospective, Randomized, Double-Blind, Active-Comparator, Pilot Study to Observe Relative Efficacy of Ultrasound-Guided Erector Spinae Plane Block (ESP) vs. Combination of Ultrasound - Guided Erector Spinae Plane Block With Serratus Anterior Plane Block in Managing Post-operative Pain Following Thoracic Surgery.

This pilot study will prospectively compare continuous Erector Spinae Plane block (ESP) versus combination of continuous Erector Spinae Plane block and single shot Serratus Anterior Plane block for post-operative pain management in subjects undergoing primary thoracic surgery.

Read the detailed description

Once consented, the patient will be randomized by computer generated random number to one of the two treatment groups.

Blinding Plan: At the acute pain management office, one member of the research team will be responsible for providing the anesthesiologist in charge of performing the block with a sealed envelope. Each envelope will be labeled with a number corresponding to a matching number labeled on each patient binder. This envelope will contain the randomized block to be administered - ESP with SAP or ESP with SAP normal saline. Once the anesthesiologist knows which block combination to administer, he/she will reseal the envelope and return it to the research team member. This process allows only the anesthesiologist performing the block to have knowledge of the block being administered, keeping both the patients and research team members blinded. The envelopes and binders will be kept by the principle investigator in a safe place and only reopened to be analyzed at the end of the study.

All study procedures will take place in the preoperative patient room in DAS prior to surgery, as is standard practice in this institution. The consent process will take place prior to performing any research procedures.

If randomized to the ESP block with SAP normal saline, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS) will administer the block with this approach: Prior to initiating the block procedure and receiving any sedative medications, patient will be asked to give 3 maximum efforts using the incentive spirometer by first taking a maximum breath in and blowing out forcefully and completely into the incentive spirometer device. Average of these three efforts will be recorded as the patient's incentive spirometer effort baseline. Patient will be positioned in seated position with side to be blocked marked. T5 spinous process will be identified by palpating starting with C7 and continuing caudad. C7 is the most prominent spinous process anatomically. T5 spinous process will be marked with a marking pen. Block area will be cleaned using 2% Chlorhexidine solution. Entire block procedure is performed under strict aseptic technique. Ultrasound probe covered in sterile probe cover will be placed at the T5 spinous process in a cephalad to caudad orientation and moved lateral until the T5 transverse process is identified. 1-2ml of 1% lidocaine will be administered just above the ultrasound probe for local skin infiltration. An 18 gauge Touhy needle will then be inserted in plane in a cephalad to caudad direction under ultrasound visualization until the tip of the needle touches the T5 transverse process. The T5 transverse process is the anatomical target for this block. 20ml of 0.375% bupivacaine will then be injected using slow fractionated injection, aspirating every 5ml to ensure needle tip is not intravascular. Local anesthetic spread in the appropriate plane will be confirmed with ultrasound. Once injection is complete, a 20 gauge non-stimulating catheter will be inserted through the Touhy needle. Catheter tip placement will be confirmed with ultrasound.

SAP Approach with normal saline - Patient will be placed in a lateral position with the side to be blocked facing up. After disinfecting the block area with 2% Chlorhexidine solution and under strict aseptic technique the ultrasound probe will be placed over the midclavicular region of the thorax in a sagittal plane. Ribs will be counted inferiorly and laterally starting with the 2nd rib, until 5th rib is identified in midaxillary line. At this level the 3 appropriate muscle layers overlying the 5th rib are easily identifiable. Latissimus dorsi M. is superficial and posterior, teres major m. is superior, and serratus m. is deep and inferior. Skin at the block site will be infiltrated with 1-2ml of 1% lidocaine, and a 20 gauge Touhy needle will be introduced in plane under ultrasound visualization in a superoanterior to posteroinferior direction just above the Serratus m. At this point 20ml Normal Saline will be injected using slow fractionated injection, aspirating every 5ml to ensure needle tip is not intravascular. Injectate spread in the appropriate plane will be confirmed with ultrasound. Total procedure time for both injections is expected to take 30 minutes from start to finish.

If randomized to the ESP+SAP block, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS) will administer the block with this approach: Incentive spirometer effort as described above. ESP performed as described above. SAP block: Patient will be placed in a lateral position with the side to be blocked facing up. After disinfecting the block area with 2% Chlorhexidine solution and under strict aseptic technique the ultrasound probe will be placed over the midclavicular region of the thorax in a sagittal plane. Ribs will be counted inferiorly and laterally starting with the 2nd rib, until 5th rib is identified in midaxillary line. At this level the 3 appropriate muscle layers overlying the 5th rib are easily identifiable. Latissimus dorsi M. is superficial and posterior, teres major m. is superior, and serratus m. is deep and inferior. Skin at the block site will be infiltrated with 1-2ml of 1% lidocaine, and a 20 gauge Touhy needle will be introduced in plane under ultrasound visualization in a superio-anterior to posterio-inferior direction just above the Serratus m. At this point 20ml 0.375% Bupivacaine will be injected using slow fractionated injection, aspirating every 5ml to ensure needle tip is not intravascular. Local anesthetic spread in the appropriate plane will be confirmed with ultrasound. Total procedure time for both injections is expected to take 30 minutes from start to finish.

For ESP block and SAP with normal saline, the local anesthetic used will be 20ml 0.375% bupivacaine for ESP block. ESP block group will also receive SAP block with 20ml Normal Saline. For ESP + SAP block group, the local anesthetic used will be 20ml 0.375% Bupivacaine for ESP block. Local anesthetic used for SAP block will be 20ml 0.375% Bupivacaine.

Anesthetic Management: Both treatment groups will receive the standard anesthetic technique and multimodal analgesic technique including preoperative Gabapentin 300mg PO and Acetaminophen 1000mg PO, intraoperative IV propofol infusion-based general anesthetic combined with sub-anesthetic dose IV ketamine infusion, IV dexmedetomidine infusion, IV acetaminophen, and strict avoidance of intraoperative opioids. Post-operative pain management will also follow standard protocol, using IV hydromorphone (0.2 mg) and PO oxycodone (5-10 mg) on request by patient for moderate to severe pain (NRS >5), IV ketamine infusion 5mg/hr for 48 hours, scheduled acetaminophen 1000mg IV for 24hours.

For study participants, the investigator placing the block will record in the narrative that "this patient is a study participant and received Paravertebral block with ESP approach and SAP block". By documenting the blocks in this way, the research team member collecting the data and the nurses documenting the pain scores will be blinded to whether patient received ESP block with 0.375% Bupivacaine + SAP block with normal saline, or ESP block with 0.375% Bupivacaine + SAP block with 0.375% Bupivacaine.

After surgery, the patient will be followed by the blinded research team for incidence of adverse events, as well as the collection of the primary and secondary outcome measures. These include total narcotic medication consumption, reported as total Morphine equivalent in 24 hours after surgery as primary outcome measures. Secondary outcome measures include pain scores at 6, 12, and 24 hours after surgery, total dose of local anesthetic administered at 12 hours and 24 hours after surgery - reported in (mg), percent change from baseline using incentive spirometer at 6 and 24 hours after block performance, total hospital length of stay - from admission to discharge, and incidence of adverse effects - nausea and vomiting requiring treatment, hypotension, and bradycardia or tachycardia. Pain assessment will be done by nurses in the PACU and on the floor using Numeric Pain Rating Scale, with 0 meaning no pain and 10 meaning worst possible pain. Narcotic medication consumption, pain scores, local anesthetic medication consumption, incentive spirometer values, and adverse effects will be recorded on worksheets included in patient research folders, with each study participant having their own research folder identified only by randomly assigned patient study number. Both nursing staff and research staff (study coordinators) collecting data will remain blinded to whether patient received ESP block with 0.375% Bupivacaine + SAP block with normal saline, or ESP block with 0.375% Bupivacaine + AP block with 0.375% Bupivacaine. Only nurses and study coordinators, not acute pain physicians, will record this data.

Patients in both study groups will receive a nerve block, either ESP alone or ESP \& SAP. Both ESP and SAP nerve blocks have an identical side effect profile, and adverse events resulting from administration of either of these blocks would be treated in an identical manner. In light of this, we do not anticipate implementing emergency unblinding of patients. However, in the case of adverse event/s occurring, emergency unblinding procedures will be the following. The principle investigator or co-investigators will be contacted and provided the patient unique study ID number, which will be used to access the master list, which includes patient study ID and the type of block received. The patient will be treated for adverse events pertaining to receiving a nerve block and/or other medications mentioned as part of the research protocol. The patient will then be removed from the study, and no further data collection will occur.

Being tested
Control Group - ESP block with SAP block, Treatment Group - ESP block with SAP normal saline
Keywords
Erector Spinae Plane block, Serratus Anterior Plane block, Thoracic Surgery, Post-operative 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.

  • Control Group - ESP block with SAP blockDrug

    Also called ESP block with SAP block

    None - Control Group

  • Treatment Group - ESP block with SAP normal salineDrug

    Also called ESP block with SAP normal saline

    Substitution of normal saline in place of 0.375% Bupivacaine in SAP block

Study groups in NCT04349774
Study groupRoleWhat they receive
Control GroupActive comparatorContinuous Erector Spinae Plane block with 20ml 0.375% Bupivacaine and continuous infusion of 0.25% Lidocaine @ 12ml/hr, with single shot Serratus Anterior Plane block with 20ml 0.375% Bupivacaine
Receives: Drug: Control Group - ESP block with SAP block
Treatment GroupActive comparatorContinuous Erector Spinae Plane block with 20ml 0.375% Bupivacaine and continuous infusion of 0.25% Lidocaine @ 12ml/hr, with single shot Serratus Anterior Plane block with 20ml Normal Saline.
Receives: Drug: Treatment Group - ESP block with SAP normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total narcotic medication consumption 24 hours after surgery

    Total narcotic medication consumption - reported as total Morphine equivalent 24 hours after surgery

    Measured: 24 hours after surgery

Secondary outcomes (5)
  1. Pain score after surgery

    Pain scores measured on a 0-10 scale

    Measured: 6,12, and 24 hours after surgery

  2. Total dose of local anesthetic medication administered after surgery

    Total dose of local anesthetic medication received following surgery - reported in (mg)

    Measured: 12 and 24 hours after surgery

  3. Percent change from baseline using incentive spirometer after nerve block administration

    Percent change in incentive spirometer value from baseline

    Measured: 6,12,and 24 hours after nerve block administration

  4. Total length of hospital stay

    Total length of hospital stay

    Measured: up to one month

  5. Incidence of adverse effects

    Nausea, vomiting, hypotension, bradycardia, tachycardia requiring treatment

    Measured: up to one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2020
  2. Study start1 Oct 2022 (estimated)
  3. Primary completion1 Jun 2023 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Why it stopped: Study was never initiated due to COVID-19

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04349774
Sponsor's protocol ID
STUDY19090184
Status last verified
Nov 2022
First submitted
13 Apr 2020
Last updated
14 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Adhikary SD, Pruett A, Forero M, Thiruvenkatarajan V. Erector spinae plane block as an alternative to epidural analgesia for post-operative analgesia following video-assisted thoracoscopic surgery: A case study and a literature review on the spread of local anaesthetic in the erector spinae plane. Indian J Anaesth. 2018 Jan;62(1):75-78. doi: 10.4103/ija.IJA_693_17.

    PubMed 29416155
  • Baidya DK, Khanna P, Maitra S. Analgesic efficacy and safety of thoracic paravertebral and epidural analgesia for thoracic surgery: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2014 May;18(5):626-35. doi: 10.1093/icvts/ivt551. Epub 2014 Jan 31.

    PubMed 24488821
  • Bang S, Chung K, Chung J, Yoo S, Baek S, Lee SM. The erector spinae plane block for effective analgesia after lung lobectomy: Three cases report. Medicine (Baltimore). 2019 Jul;98(29):e16262. doi: 10.1097/MD.0000000000016262.

    PubMed 31335674
  • Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.

    PubMed 23923989
  • Chin KJ. Thoracic wall blocks: From paravertebral to retrolaminar to serratus to erector spinae and back again - A review of evidence. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):67-77. doi: 10.1016/j.bpa.2019.02.003. Epub 2019 Apr 5.

    PubMed 31272655
  • Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.

    PubMed 28272292
  • 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 28614112
  • Cook TM, Riley RH. Analgesia following thoracotomy: a survey of Australian practice. Anaesth Intensive Care. 1997 Oct;25(5):520-4.

    PubMed 9352765
  • Davies RG, Myles PS, Graham JM. A comparison of the analgesic efficacy and side-effects of paravertebral vs epidural blockade for thoracotomy--a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2006 Apr;96(4):418-26. doi: 10.1093/bja/ael020. Epub 2006 Feb 13.

    PubMed 16476698
  • Fang B, Wang Z, Huang X. Ultrasound-guided preoperative single-dose erector spinae plane block provides comparable analgesia to thoracic paravertebral block following thoracotomy: a single center randomized controlled double-blind study. Ann Transl Med. 2019 Apr;7(8):174. doi: 10.21037/atm.2019.03.53.

    PubMed 31168455
  • 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.

    PubMed 27501016
  • Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.

    PubMed 28252539
  • Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.

    PubMed 28919152
  • Gaio-Lima C, Costa CC, Moreira JB, Lemos TS, Trindade HL. Continuous erector spinae plane block for analgesia in pediatric thoracic surgery: A case report. Rev Esp Anestesiol Reanim (Engl Ed). 2018 May;65(5):287-290. doi: 10.1016/j.redar.2017.11.010. Epub 2018 Jan 19. English, Spanish.

    PubMed 29370900
  • Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.

    PubMed 18456219

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Treatment Group - ESP block with SAP normal saline in people with Pain, Postoperative, run by Anna Uskova at 1 site in United States.

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 5 inclusion and 12 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: withdrawn, as of the sponsor's last update on 14 Nov 2022. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Total narcotic medication consumption 24 hours after surgery (time frame: 24 hours after surgery). 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 NCT04349774, which also lists 40 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 14 Nov 2022.

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