200 Participants Needed

Pain Management for VATS

AB
Overseen ByAbhijit Biswas, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Trial Summary

What is the purpose of this trial?

Video assisted thoracic surgery (VATS) has emerged as standard of care for majority of thoracic surgeries. It is less invasive compared to thoracotomy and is associated with improved perioperative outcomes \[1-3\]. Good perioperative analgesia after thoracic surgery will enable pulmonary toilet, early chest physiotherapy and mobilisation, \[4,5,6\]. Thirty-day hospital visits and hospital readmissions at London Health Sciences Centre (LHSC) is around 21% and 9% respectively \[7\]. One of the top five determinant for hospital visit and readmission in 30 days, was persistent post operative pain \[7\]. Several options to analgesia are available for patients undergoing VATS procedure. Systemic opioid based multimodal analgesia, central neuraxial blocks like thoracic epidural and peripheral nerve blocks are different available options, and their practise varies across institution \[4,8,9\]. Thoracic epidural or paravertebral blocks can be challenging to perform with high failure rates \[10-12\]. Fascial plane blocks (SAB; ESP) are in vogue in the present era \[13-16\]. They are easy to perform and do not require similar dexterity as needed to perform thoracic epidural or paravertebral blocks. They have minimal side effects and provide the options for continuous infusion for prolonged analgesia. They have become an effective part of multimodal analgesia and have established their roles in ERAS (enhanced recovery after surgery) protocol for VATS procedures. SAB has become a common practise at our institution with proved clinical efficacy. Perioperative Surgical Home is a patient centric team-based approach to improve patient's experiences in the perioperative period and thus improve healthcare \[17\]. Quality of Recovery (QoR) is a key determinant to perioperative surgical home and can be measured using the QoR 40 score \[18\]. This is a well validated score with a minimal important clinical difference (MICD) of 6.3 \[19\]. Quality of recovery combines five dimensions of health: patient support, comfort, emotions, physical independence and pain to achieve a single patient outcome - improved patient care \[18\]. The investigators hypothesize the that patients undergoing VATS lung resections using a combination of intercostal nerve block plus continuous SAB catheter infusion of local anesthetics will have a 20% increase in their QoR-40 score 24hour after the surgery compared to a single shot intercostal nerve block.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves pain management techniques, it's best to discuss your current medications with the trial coordinators or your doctor.

What data supports the idea that Pain Management for VATS is an effective treatment?

The available research shows that Pain Management for VATS, specifically using the serratus anterior plane block (SAPB) and intercostal nerve block (ICNB), is effective in reducing pain after surgery. One study compared SAPB and ICNB and found both to be attractive options for pain relief after thoracoscopic surgery. Another study found that SAPB was effective in managing pain after single port video-assisted thoracoscopic surgery. Additionally, a systematic review and meta-analysis showed that SAPB was effective compared to other pain management techniques like paravertebral and intercostal blocks. These studies suggest that SAPB and ICNB are effective treatments for managing pain after VATS.12345

What safety data exists for pain management using serratus anterior plane block or intercostal nerve block?

The studies indicate that both serratus anterior plane block (SAPB) and intercostal nerve block (ICNB) are used for postoperative analgesia in thoracoscopic surgeries and breast surgeries. SAPB is a novel technique that effectively relieves pain and improves recovery quality. Anatomical studies show that SAPB involves the lateral cutaneous branches of the intercostal nerves. While the safety of these blocks is implied through their use in clinical settings, specific safety data is not detailed in the abstracts provided.12678

Is the treatment Intercostal Block, Serratus Plane Block promising for pain management after VATS surgery?

Yes, the Serratus Plane Block and Intercostal Block are promising treatments for managing pain after VATS surgery. They are both effective in reducing pain, and studies suggest they are good options for pain relief after this type of surgery.12359

Research Team

AB

Abhijit Biswas, MD

Principal Investigator

Western University, Canada

Eligibility Criteria

This trial is for adults over 18 years old undergoing elective lung surgery (VATS) with varying health statuses (ASA score 1-4), regardless of gender, who can consent to participate. It's not suitable for those unable to give consent or meet the specific surgical and health criteria.

Inclusion Criteria

I am older than 18 years.
ASA (American Society of Anesthesiology) Score - 1 to 4
Patients able to consent to participate in the study
See 2 more

Exclusion Criteria

I have had emergency surgery.
I have been experiencing pain for more than six months.
I have had part of my lung removed on the same side before.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo VATS procedures with either intercostal block and serratus plane catheter with local anesthetic or placebo

1 day
1 visit (in-person)

Postoperative Care

Participants receive postoperative pain management and monitoring in the PACU with opioid-based PCA and ropivacaine or saline infusion

Until discharge, on average one week
Daily assessments until discharge

Follow-up

Participants are monitored for postoperative complications and hospital readmission

30 days

Treatment Details

Interventions

  • Intercostal Block
  • Serratus Plane Block
Trial Overview The study compares pain management in VATS patients using two methods: a single intercostal block versus an intercostal block combined with continuous local anesthetic infusion via a Serratus Plane Block catheter. The goal is to see if the combination method improves recovery quality scores.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Serratus Plane Block (Local Anesthetic) and Intercostal Block (Local Anesthetic)Experimental Treatment1 Intervention
Patients randomized to this group will receive the intercostal block with local anesthetic and the serratus plane block with local anesthetic. Local anesthetic administered will be ropivacaine 0.2%.
Group II: Serratus Plane Block (Placebo) and Intercostal Block (Local Anesthestic)Placebo Group1 Intervention
Patients randomized to this group will receive the intercostal block with local anesthetic and the serratus plane block with saline placebo. Local anesthetic administered will be ropivacaine 0.2%.

Find a Clinic Near You

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
686
Recruited
427,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
668
Recruited
424,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
678
Recruited
421,000+

Lawson Health Research Institute

Lead Sponsor

Trials
684
Recruited
432,000+

Findings from Research

In a study of 54 patients undergoing single port video-assisted thoracoscopic surgery for primary spontaneous pneumothorax, the ultrasound-guided serratus anterior plane block (SAPB) provided comparable postoperative pain relief to the intercostal nerve block (ICNB).
Patients receiving SAPB required significantly fewer nonsteroidal anti-inflammatory drugs (NSAIDs) postoperatively compared to those receiving ICNB, indicating a potential advantage in reducing medication consumption while maintaining effective pain management.
Serratus Anterior Plane Block and Intercostal Nerve Block after Thoracoscopic Surgery.Kim, S., Bae, CM., Do, YW., et al.[2022]
In a study involving 50 patients undergoing video-assisted thoracoscopic surgery (VATS), both the serratus anterior plane block (SAPB) and intercostal nerve block (ICNB) showed similar effectiveness in reducing postoperative pain, as measured by numerical pain rating scale (NRS) scores.
There were no significant differences in the cumulative use of pain medications (fentanyl and ketorolac) between the two groups, and no serious adverse events were reported, indicating both techniques are safe options for pain management.
Serratus anterior plane block versus intercostal nerve block for postoperative analgesic effect after video-assisted thoracoscopic lobectomy: A randomized prospective study.Lee, J., Lee, DH., Kim, S.[2022]
The study analyzed 16 randomized controlled trials comparing the serratus anterior plane block (SAB) with paravertebral block (PVB) and intercostal block (ICB) for pain management in surgical patients, finding no significant differences in pain scores or time to first analgesic request between SAB and PVB.
While there may be a trend towards higher total analgesic consumption with SAB compared to PVB, the evidence is conflicting, and further research is needed to clarify the efficacy of SAB compared to ICB.
Efficacy of Serratus Anterior Plane Block vs Paravertebral and Intercostal Blocks for Pain Control after Surgery: A Systematic Review and Meta-analysis.Qian, P., Zheng, X., Wei, H., et al.[2023]

References

Serratus Anterior Plane Block and Intercostal Nerve Block after Thoracoscopic Surgery. [2022]
Serratus anterior plane block versus intercostal nerve block for postoperative analgesic effect after video-assisted thoracoscopic lobectomy: A randomized prospective study. [2022]
Efficacy of Serratus Anterior Plane Block vs Paravertebral and Intercostal Blocks for Pain Control after Surgery: A Systematic Review and Meta-analysis. [2023]
Comparison of the Efficacy of Ultrasound-Guided Serratus Anterior Plane Block, Pectoral Nerves II Block, and Intercostal Nerve Block for the Management of Postoperative Thoracotomy Pain After Pediatric Cardiac Surgery. [2019]
Rhomboid Intercostal and Serratus Anterior Interfascial Plane Blocks for the Treatment of Post-Operative Pain after Video-Assisted Thoracoscopic Surgery: A Retrospective Propensity-Matched Study. [2023]
[Serratus-Intercostal Plane Block for Brest Surgery]. [2018]
Serratus Anterior Plane Block Combined with General Analgesia and Patient-Controlled Serratus Anterior Plane Block in Patients with Breast Cancer: A Randomized Control Trial. [2021]
An anatomical evaluation of the serratus anterior plane block. [2022]
A comparison of the analgesic efficacy of serratus anterior plane block vs. paravertebral nerve block for video-assisted thoracic surgery: a randomized controlled trial. [2022]
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