Efficacy of SAP Block Versus ESP Block in VATS Surgery

NCT03862612 | Completed

• 1 other identifier: ESPverusSAP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Regional Anesthesia Morbidity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  24 hours post op

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

  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

Study Arms (2)

Erector Spinae Plane Block

ACTIVE COMPARATOR

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

Serratus Anterior Plane Block

EXPERIMENTAL

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

Interventions

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

Erector Spinae Plane Block; Serratus Anterior Plane Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 \[because of need to co-operate in completing QoR-15 score day after surgery\].

Sponsors & Collaborators

• Mater Misericordiae University Hospital: lead

Study Sites (1)

Mater Misericordiae University Hospital

Dublin, D07 R2WY, Ireland

Location

Related Publications (1)

• 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.

  PMID: 32660716 DERIVED

MeSH Terms

Interventions

Anesthesia, Conduction

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Donal Buggy

  Professor of Anaesthesia and Perioperative Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Blocks will be administered after induction of General Anesthesia so participants will be blinded to which intervention they have had. Study investigators will not be aware as to what group the participant belongs to when assessing the patient post operative period
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomised control trial one group receives Serratus Anterior Plane Block the other receives Erector Spinae Plane Block

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 5, 2019
• Study Start: June 5, 2019
• Primary Completion: March 5, 2020
• Study Completion: April 2, 2020
• Last Updated: May 4, 2020

Record last verified: 2020-04

Locations

IE (1)