This trial studies how well serratus anterior plane block works in relieving pain in patients who are undergoing lung surgery. Serratus anterior plane block involves injection of a local anesthetic called bupivacaine under the serratus anterior muscle (located on the first 8 ribs on the side of the chest). Two other medications, clonidine and dexamethasone, are added to the local anesthetic to make the numbing effect of bupivacaine last longer. Giving serratus anterior plane block during lung surgery may help to minimize the use of opioids after surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04238455.
PRIMARY OBJECTIVE:
I. To determine if the addition of an intraoperative serratus anterior plane block to usual care decreases the postoperative opioid requirement in the first 24 postoperative hours in adult patients undergoing elective minimally invasive lung resection compared to patients receiving a sham serratus anterior plane block plus usual care.
SECONDARY OBJECTIVES:
I. To determine if the addition of an intraoperative serratus anterior plane block to usual care decreases the postoperative opioid requirement in the first 48 postoperative hours in adult patients undergoing elective minimally invasive lung resection compared to patients receiving a sham block plus usual care.
II. To determine if the addition of an intraoperative serratus anterior plane block to usual care reduces postoperative pain scores at rest on the 11-point numeric rating scale (NRS) in the first 48 postoperative hours in adult patients undergoing elective minimally invasive lung resection compared to sham block plus usual care.
III. To determine if the addition of an intraoperative serratus anterior plane block to usual care improves peak flow on incentive spirometry for patients at 24 and 48 postoperative hours versus preoperative baseline values when compared to patients receiving sham block plus usual care for elective minimally invasive lung resection.
EXPLORATORY OBJECTIVES:
I. To determine if the addition of an intraoperative serratus anterior plane block plus usual care reduces the incidence of postoperative nausea and vomiting (PONV) in the first 48 postoperative hours in adult patients undergoing elective minimally invasive lung resection compared to patients having a sham block plus usual care.
II. To determine if the addition of an intraoperative serratus anterior plane block to usual care improves patient score on the Quality of Recovery – 15 (QoR-15) assessment at one week postoperatively when compared to patients receiving a sham block plus usual care for elective minimally invasive lung resection.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive sham serratus anterior plane block with saline during lung surgery.
GROUP II: Patients receive serratus anterior plane block with bupivacaine hydrochloride and dexamethasone and clonidine adjuvants during lung surgery.
After completion of study, patients are followed up for 48 postoperative hours or until hospital discharge and then at 1 week.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJacob Jackson
