Efficacy of SAP Block Versus ESP Block in VATS Surgery (ESPvSAP)

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

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

Study Overview

• Status: Completed
• Conditions: Regional Anesthesia Morbidity
• Intervention / Treatment: Procedure: regional anaesthesia with Levobupivicaine 0.25% 30mls with two methods either erector spinae plane block or serratus anterior plane block

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, D07 R2WY
    • Mater Misericordiae University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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].

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erector Spinae Plane Block; This group will receive an Erector Spinae Plane Block under ultrasound guidance while under General Anaesthesia	Procedure: regional anaesthesia with Levobupivicaine 0.25% 30mls with two methods either erector spinae plane block or serratus anterior plane block; Erector Spinae Plane Block will be compared to the Serratus Anterior Plane Block in patients undergoing Video assissted thoracic surgery
Experimental: Serratus Anterior Plane Block; This group will receive a Serratus Anterior Plane Block under ultrasound guidance while under General Anesthesia	Procedure: regional anaesthesia with Levobupivicaine 0.25% 30mls with two methods either erector spinae plane block or serratus anterior plane block; Erector Spinae Plane Block will be compared to the Serratus Anterior Plane Block in patients undergoing Video assissted thoracic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the patient centred QoR-15 score among ESB and SAP block patients;	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the Verbal Rating Scale (VRS) pain score versus time (24 hr post-op	Verbal Rating Scale pain score is measured from 0 to 10 where 0 is no pain and 10 is severe pain	24 hours post op
. VRS pain scores at 1 hr, 12 hr, 24 hr postop	0-10 where 10 equals severe pain and 0 is no pain	24 hours post op
time to administration of first rescue analgesia after the block		24hours post op
documentation of adverse events : hypotension, pruritus, nausea and vomiting		24 hours post op

Collaborators and Investigators

• Sponsor: Mater Misericordiae University Hospital
• Investigators: Principal Investigator: Donal Buggy, Professor of Anaesthesia and Perioperative Medicine

Publications and helpful links

General Publications

• Finnerty DT, McMahon A, McNamara JR, Hartigan SD, Griffin M, Buggy DJ. Comparing erector spinae plane block with serratus anterior plane block for minimally invasive thoracic surgery: a randomised clinical trial. Br J Anaesth. 2020 Nov;125(5):802-810. doi: 10.1016/j.bja.2020.06.020. Epub 2020 Jul 11.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2019
• Primary Completion (Actual): March 5, 2020
• Study Completion (Actual): April 2, 2020

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: March 2, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: ESPverusSAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No