This clinical trial compares standard local anesthesia along with a nerve block with lidocaine and epinephrine to a placebo nerve block for the reduction of pain and anxiety in patients undergoing Mohs micrographic surgery on the face or scalp for skin cancer. Standard local anesthesia uses injections of lidocaine and epinephrine given in small amounts to the area around the surgical site to numb the area. A regional nerve block uses the same medications given to the nerve. This kind of numbing medicine works on a larger area of skin and might provide better pain control than the small, local shots that are usually used. This may reduce pain and anxiety in patients undergoing Mohs micrographic surgery on the face or scalp for skin cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07222241.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer CenterStatus: Active
Contact: Christopher Miller
Phone: 215-360-0909
PRIMARY OBJECTIVE:
I. To determine whether patients experience less pain and anxiety during stage 1 of Mohs micrographic surgery (MMS) of face and scalp skin cancers when they receive standard local infiltration at the tumor site with regional nerve block versus placebo nerve block.
SECONDARY OBJECTIVE:
I. To compare the following outcomes between cohorts that receive standard local infiltration at the tumor site with regional nerve block versus placebo nerve block during stage 1 of MMS on the face and scalp:
Ia. Patient anxiety;
Ib. Total number of local needle sticks;
Ic. Total anesthetic volume stratified by application (nerve block, local infiltration, preventative, and rescue);
Id. Presence/absence and frequency of rescue anesthesia required during stage 1;
Ie. Patient satisfaction at the end of stage 1.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive standard of care local anesthetic infiltration of the tumor site with lidocaine and epinephrine and placebo nerve block injection with normal saline. Patients then undergo standard of care Mohs micrographic surgery.
ARM 2: Patients receive standard of care local anesthetic infiltration of the tumor site with lidocaine and epinephrine and nerve block injection with lidocaine and epinephrine. Patients then undergo standard of care Mohs micrographic surgery.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorChristopher Miller
