Efficacy of SAP Block Versus ESP Block in VATS Surgery

NCT ID: NCT03862612

Last Updated: 2020-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-05
• Study Completion Date: 2020-04-02

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

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.

Conditions

Regional Anesthesia Morbidity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Erector Spinae Plane Block

This group will receive an Erector Spinae Plane Block under ultrasound guidance while under General Anaesthesia

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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

Serratus Anterior Plane Block

This group will receive a Serratus Anterior Plane Block under ultrasound guidance while under General Anesthesia

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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].

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mater Misericordiae University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dylan Finnerty

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donal Buggy

Role: PRINCIPAL_INVESTIGATOR

Professor of Anaesthesia and Perioperative Medicine

Locations

Mater Misericordiae University Hospital

Dublin, , Ireland

Countries

Ireland

References

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.

Reference Type: DERIVED

PMID: 32660716 (View on PubMed)

Other Identifiers

ESPverusSAP

Identifier Type: -

Identifier Source: org_study_id