The Effect of Pectoral Blocks on Perioperative Pain in Gender Affirmation Top Surgery
Condition: Gender Dysphoria; Opioid Use; Pain, Postoperative
MeSH terms: Pain, Postoperative; Gender Dysphoria
Study type: Interventional
Phase: Phase 4

Summary: 
      Despite recent advancements with regional and local anesthesia, postoperative pain continues
      to be a major concern for patients undergoing breast surgery. Opioids, often in combination
      with NSAIDS and/or gabapentioids, have been the main pharmacologic pain control strategy in
      the postoperative period. The pectoral nerve block is a regional anesthetic technique, which
      is effective at providing postoperative anesthesia in breast surgeries. However, this has
      only been studied in oncologic-related breast operations. It is our aim to study the effects
      of pectoral regional nerve blocks in patients undergoing breast reduction for gender
      affirmation. The overall goal is to establish an effective pain control regimen utilizing
      regional anesthetic techniques in this patient population. The specific objective of this
      proposal is to evaluate the effectiveness of these blocks on perioperative and postoperative
      analgesia. The hypothesis is that participants undergoing gender-affirmation breast surgery
      who receive a pectoral nerve block will have less perioperative and postoperative pain as
      well as reduced opioid consumption compared to those receiving a placebo. Participants who
      are undergoing gender affirmation breast reduction surgery will be randomized to either
      receive a preoperative nerve block or to receive a placebo. Intraoperative and postoperative
      opioid requirements will be compared in addition to post-operative pain scores. Participants
      will be asked to fill out a pain diary during their first week postoperatively. They will
      also be asked to document if, and when, narcotic pain medication was required for pain
      control. The two groups will be compared to determine if there was any difference in pain
      scores as well as narcotic medication requirements.
    

Detailed description: 
      All participants will be seen in clinic with the attending surgeon anywhere from two weeks to
      a few months prior to the date of surgery. Participants will also have a pre-op visit with
      anesthesia a few weeks before surgery. They will undergo a standard anesthesia preoperative
      evaluation, which will include a medical chart review, physical exam, and appropriate
      laboratory studies. The preoperative evaluation will be identical for those participating in
      the study and those who do not. If no contraindications to the Pectoralis Nerve Block (PECS I
      and II block) are identified by the surgeon and/or anesthesiologist, participants will be
      approved to participate. The participants will be introduced to the study either during their
      clinic visit prior to surgery or over the telephone a few days prior to surgery. All
      questions will be answered by one of the study investigators. A study consent will be
      obtained from the participants and they will then will be randomized into either control
      (sham block) or experimental (PECS I and II block) group.

      On the day of surgery, as per standard of care, each participant will undergo a general
      anesthetic in the same manner with conventional perioperative management. During induction of
      anesthesia, up to 2mg of midazolam and/or up to 100mcg of fentanyl will be given. The above
      protocol will be followed regardless of study participation and study group (if
      participating). After induction of anesthesia, the nerve blocks, or control blocks, will be
      performed. The regional anesthesia team will be involved in all patients, whether in the
      control or intervention group. All patients will be come and go regardless of group.

      Group 1 (control) will receive an injection of 20ml of saline between the pectoralis minor
      and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and
      pectoralis major muscles bilaterally.

      Group 2 (treatment) will receive an injection of 20ml of 0.2% Ropivacaine between the
      pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine
      between the pectoralis minor and pectoralis major muscles bilaterally. (Not to exceed 225mg
      or 3.5mg/kg).

      PECS I and II Block Technique: Performed in the supine position with the arms abducted 90
      degrees at the shoulder. Using an ultrasound transducer in the parasagittal plane, the
      axillary artery and vein are identified just inferior to clavicle and medial to coracoid
      process. Additionally, the 2nd rib is identified and the transducer is slid inferiorly until
      the 3rd and 4th rib are identified. At this point the pectoralis major, minor, and serratus
      anterior muscles are seen. Then the block needle is inserted through the skin and advanced
      into the fascial plane between pectoralis minor and serratus anterior muscles. After negative
      aspiration, the anesthetic is injected into the plane watching for hydrodissection of the
      muscles. A total volume of 20ml is injected. Then the needed is withdrawn until the tip is
      located in the fascial plane between the pectoralis major and minor muscles. 10ml of
      anesthetic is injected into this plane.

      General anesthesia is maintained in the standard fashion. The anesthesiologist will
      administer Fentanyl as he or she feels necessary during the operation. Post operatively, in
      the PACU, participants will be given IV hydromorphone as needed for pain. Pain scales will be
      documented at set time points post operatively and participants will be given pain diaries to
      document these pain scores as well as their opioid consumption. All patients will be sent
      home with a prescription for 20 tablets of Norco 5mg/325mg. Participants will be asked to
      document their pain scores at the following post op time points: 1 hour, 2 hours, 4 hours, 6
      hours, 12 hours, 24 hours, 48 hours, 72 hours, 1 week. Participants will return their pain
      diaries at the 1 week post operative visit. This visit is a standard of care follow up visit.
    

Intervention name(s): Ropivacaine 0.2% Injectable Solution; Saline (0.9%)
Intervention type(s): Drug; Other
Intervention description(s): Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block; Saline injection as sham block in identical fashion as Pectoralis Nerve Block
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention