Efficacy of SAP Block Versus ESP Block in VATS Surgery

Regional Anesthesia Morbidity Clinical Trial

— ESPvSAP  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862612
• Other study ID #: ESPverusSAP
• Status: Completed
• Phase: N/A
• Start date: June 5, 2019
• Est. completion date: April 2, 2020

Study information

• Verified date: April 2020
• Source: Mater Misericordiae University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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].

Related Conditions & MeSH terms

• Regional Anesthesia Morbidity

Intervention

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

Locations

Country	Name	City	State
Ireland	Mater Misericordiae University Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Mater Misericordiae University Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	. 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
Secondary	time to administration of first rescue analgesia after the block		24hours post op
Secondary	documentation of adverse events : hypotension, pruritus, nausea and vomiting		24 hours post op