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Completed

NCT Number: NCT03862612

Efficacy of SAP Block Versus ESP Block in VATS Surgery

During VATS (Video assisted thoracic surgery) small incisions are made in the patient's chest through which a camera and instruments are inserted to allow a lung operation to be performed. Often patients experience a substantial amount of pain and difficult recovery after this type of operation. Anaesthesiologists sometimes use "Regional Anaesthesia" to minimise the pain and help patient recovery after the operation. This involves injecting local anaesthesia into the nerves around the chest wall to effectively numb that part of the chest. There is a variety of different locations on the chest wall where the local anaesthetic can be deposited and no study has measured whether one technique is better than the other in terms of improving patients' recovery experience. Our study compares two new techniques for Regional Anaesthesia after this type of surgery. Participants will be randomly assigned (like tossing a coin) to receive either a SAP (Serratus Anterior Plane) or ESP (Erector Spinae Plane) Block. Both techniques are described within last five years, but have never been compared for chest surgery

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Key information

Conditions

Regional Anesthesia Morbidity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mater Misericordiae University Hospital

Dublin, D07 R2WY, Ireland

About this study

The Serratus Anterior Plane (SAP) Block has been claimed to be a safer, technically less demanding alternative to paravertebral block and thoracic epidural in the management of post operative VATS associated pain . Recently, another new block, the Erector Spinae Block (ESP Block) has been described for use in thoracic wall surgery. It has also been claimed to be easier to perform than these more traditional methods of regional anaesthesia. No study to date has compared ESP to SAP blocks in terms of efficacy of post operative analgesia after VATS surgery. Furthermore, patient-centres outcome studies now demand that researchers evaluate more than acute pain in the early postoperative period: A 15-parameter Quality of Recovery score (QoR-15) has been recommended as the optimum tool to evaluate overall patient-centres measures of recovery after surgery, including pain. This study will test the hypothesis that patients receiving ESP Block have higher QoR-15 scores and better post operative analgesia in comparison with patients receiving SAP Block after VATS surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and Female participants providing written informed consent,
  • ASA grade 1- 4,
  • aged over 18
  • undergoing a VATS procedure under General Anaesthesia

Exclusion criteria

  • Absence of informed written consent,
  • pre existing infection at block site,-
  • severe coagulopathy,
  • allergy to local anaesthesia,
  • pre existing neurological deficit,
  • previous history of opiate abuse,
  • pre existing chronic pain condition,
  • pre-existing dementia [because of need to co-operate in completing QoR-15 score day after surgery].

Treatment and study plan

regional anaesthesia with Levobupivicaine 0.25% 30mls with two methods either erector spinae plane block or serratus anterior plane block

Procedure

Erector Spinae Plane Block will be compared to the Serratus Anterior Plane Block in patients undergoing Video assissted thoracic surgery

Primary outcomes

  1. the patient centred QoR-15 score among ESB and SAP block patients;

    Time frame: 1 year

    A 15-parameter Quality of Recovery score (QoR-15) has been recommended as the optimum tool to evaluate overall patient-centres measures of recovery after surgery, including pain. It is a questionnaire that is given to patients to do post operatively and is scored from 0 to 150 where 150 indicates that the patient has a had an excellent recovery

Secondary outcomes

  1. Area under the Verbal Rating Scale (VRS) pain score versus time (24 hr post-op

    Time frame: 24 hours post op

    Verbal Rating Scale pain score is measured from 0 to 10 where 0 is no pain and 10 is severe pain

  2. . VRS pain scores at 1 hr, 12 hr, 24 hr postop

    Time frame: 24 hours post op

    0-10 where 10 equals severe pain and 0 is no pain

  3. time to administration of first rescue analgesia after the block

    Time frame: 24hours post op

  4. documentation of adverse events : hypotension, pruritus, nausea and vomiting

    Time frame: 24 hours post op

Sponsors and collaborators

Lead sponsor

Mater Misericordiae University Hospital

Other

Registry information

Official study title

Efficacy of Serratus Anterior Plane (SAP) Block Versus Erector Spinae Plane (ESP) Block for Quality of Recovery After Video Assisted Thoracic Surgery : A Randomised Control Trial

Acronym: ESPvSAP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2019
Registry last updated
May 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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