Efficacy Between Serratus Plane Block And Local Infiltration In Vats

Lung Cancer Clinical Trial

Official title:

Comparison Between Serratus Plane Block And Local Surgical Infiltration In Robotic Video Assisted Thoracoscopic Surgery- A Randomised Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03642457
• Other study ID #: GCO 17-1294
• Status: Terminated
• Phase: Phase 4
• Start date: March 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Robotic video-assisted thoracoscopic surgery (VATS) is increasingly being used as it is a less invasive surgery compared to traditional methods, but the acute pain at an early stage after VATS has a major impact on perioperative outcomes. Effective post operative analgesia is believed to reduce morbidity, quicken recovery, improve patient outcome and reduce hospital costs. The site and extent of the incision influences the degree of pain due to disruption of intercostal nerves as well as inflammation of chest wall and pleura. Neuraxial and systemic opioids have been a gold standard as a part of multimodal analgesia for thoracic surgeries. Numerous modalities have been studied: thoracic paravertebral nerve blocks, thoracic epidural analgesia, intercostal nerve blocks, patient controlled analgesia (PCA), cryo-analgesia, transcutaneous electrical nerve stimulation (TENS), inter-pleural blocks, stellate ganglion blocks, long thoracic nerve blocks, and infiltration under direct vision by the surgeon.

Serratus plane block is an emerging regional technique that has proven to be effective in comparison to paravertebral blocks in patients undergoing breast surgery and mastectomy with reduced perioperative opioid consumption and improved pain scores.

The lateral pectoral nerve, medial pectoral nerve, intercostal nerves and long thoracic nerve are all targets for the serratus plane block. It can be safely performed under ultrasound guidance.

The purpose of the study is to evaluate the difference in quality of analgesia between efficacy of serratus plane block and local surgical infiltration by surgeon as measured by patient opioid consumption and pain scores.

Description:

Participants will be assigned randomly using a computer-generated table of numbers to either serratus group or infiltration group. Block team will perform all blocks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• ASA (American Society of Anesthesiology) class I-IV

• age 81-75

Exclusion Criteria:

• ASA class V

• morbid obesity

• patient refusal

• patients with chronic pain or on pain medications

• allergy to LA

• patients receiving any additional regional techniques

• coagulopathy

• patients receiving systemic anticoagulation

• local infection

• procedures anticipated to last more than 5 hours.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Drug:
• Bupivacaine
20 cc 0.5%
• Bupivacaine liposome
133mg liposomal bupivacaine

Locations

Country	Name	City	State
United States	Mount Sinai St. Luke's Hospital	New York	New York
United States	Mount Sinai West Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (3)

Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. — View Citation

Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223. — View Citation

Thoracic paravertebral block versus pectoral nerve block for analgesia after breast surgery. Egypt J Anaesth. 2013; 30: 129-135. Wahba, SS and Kamal, SM.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Opioid Consumption	The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure.	up to 24 hours post procedure
Secondary	Time to First Dose of Narcotic Administration	Time to first dose of narcotic administration post procedure	up to 24 hours post procedure
Secondary	PACU Length of Stay	The length of stay post procedure in the PACU	average 3-4 hours post procedure
Secondary	ICU Length of Stay	The length of stay post procedure in the or ICU	up to 40 hours post procedure
Secondary	Visual Analogue Score (VAS)	Visual Analogue Score (VAS) pain score from 0 (no pain) to 10 (most pain)	up to 24 hours post procedure
Secondary	Patient Satisfaction Score	Patient satisfaction score from 0 (not satisfied) to 10 (extremely satisfied)	up to 24 hours post procedure