Efficacy of Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy

Patients will be randomized into either a test group receiving an ultrasound-guided TAP block
with ropivacaine and peri-portal sterile saline or the control group that will receive
ultrasound-guided TAP block with sterile saline and peri-portal infiltration of ropivicaine.
All patients, who are scheduled to undergo laparoscopic cholecystectomy who meet the
inclusion/exclusion criteria, and their parent(s)/guardian(s) will be called by the study
staff the afternoon before surgery, who will follow a study script introducing the project
and providing them with an opportunity to enroll in this study or opt out. If the patient
cannot be reached the day before surgery, they will be offered the opportunity to enroll the
day of surgery in the pre-operative holding area. If the decision is made to participate in
the study, a physician study investigator will obtain appropriate consent and assent when
applicable. Recruitment materials will be provided, if desired. A copy of this consent form
will be placed in the Boston Children's Hospital medical record and a separate research
record.

Stratified randomization of patients will be conducted by the pharmacy to maintain the
double-blinded nature of the study. The pharmacy staff will deliver a study syringe labeled
"regional" and a study syringe labeled "local". Depending on randomization, the "regional"
syringe will be filled with either ropivacaine 0.2% or normal saline to the corresponding
volume based on the dosing outlined. Similarly, the local syringe will be filled with the
opposite solution. Thus, if the "regional" syringe is filled with ropivacaine, the local
syringe will be filled with normal saline, and vice versa.

Both surgical and anesthesia teams will be blind to the intervention received by the patient.

The patients will be divided into two groups: 1. Abdominal Wall Block with Ropivacaine and 2.
Surgical infiltration with Ropivacaine.

The abdominal wall block group will receive: bilateral transversus abdominis plane and rectus
sheath blocks via ultrasound guidance. A total of 1.0ml/kg distributed between the four
blocks (0.4+0.4+0.1+0.1) of 0.2% Ropivacaine (max 50ml) will be injected, as a one time
single shot injection, into the fours sites. Surgical infiltration of the four port sites
will receive 0.4ml/kg of sterile saline.

The surgical infiltration group will receive: surgical infiltration of local anesthetic into
the 4 laparoscopic port sites. A total of 0.4 ml/kg (0.1+0.1+0.1+0.1) of 0.5% Ropivacaine,
divided between the four port sites (max 20 ml), will be used. A total of 1ml/kg, divided
between the TAP (0.4ml/kg on each side) and RS (0.1ml/kg on each side), of sterile saline
will be used for the nerve blocks.

Intra-operative Methods: After induction of anesthesia, but before the first incision, each
patient will receive an ultrasound-guided block by the regional anesthesiologist as follows:

A. Block Placement:

a. Time out performed for procedure b. Site prepared using aseptic technique c. Localization
of the bilateral posterior TAP plane and bilateral rectus sheaths using a portable ultrasound
machine i. Aseptic preparation of probe with sterile sheath ii. 38mm linear probe (BK
Medical, USA) iii. 15 MegaHertz frequency d. Needle: 22g 80mm echogenic e. Drug
administration per protocol and group allocation

B. Periportal Infiltration:

a. Injection of drug and volume per protocol into the planned insertion sites for the 4
ports.

All patients will receive acetaminophen IV 15 mg/kg, dexamethasone 0.1 mg/kg, and morphine
0.05 mg/kg after induction of anesthesia but prior to the first incision. At the conclusion
of surgery, prior to emergence, each patient will receive ketorolac IV 0.5 mg/kg (max 30 mg).
All intraoperative details of care including vitals signs, medication administration,
complications, and timing of events are recorded in the electronic anesthesia record.

PACU Methods: Pain will be assessed post-operatively in the PACU (Post-Anesthesia Care Unit)
using the FLACC, FACES Pain Rating Scale or Numeric Rating Scale (NRS) as per PACU protocol
and as appropriate to patient age. Once the patient is awake and able to respond to
questions, a pain score will be obtained and documented by a study investigator until
discharge from the recovery room. Morphine 0.05 mg/kg IV will be administered for NRS, FLACC,
or FACES score greater than 4. This can be repeated every 10 minutes to a total of 4 doses.
Doses, times, and types of all medications administered in the PACU, in addition to the
duration of time a patient spends in the PACU, are documented in the electronic medical
record (per standard PACU protocol). Post-anesthetic complications are documented by the PACU
nurse in the electronic medical record. Trained research personnel will evaluate for the
presence or absence of periumbilical analgesia prior to discharge from PACU. The patient will
be discharged from the PACU to an in-patient bed when standard PACU discharge criteria are
met.

Inpatient Methods: All patients will receive standard postoperative orders to include
acetaminophen 15 mg/kg IV q 6 hours, ketorolac 0.5 mg/kg IV q6 hours, morphine 0.05 mg/kg IV
q 2 hours as needed, and oxycodone 0.15 mg/kg PO Q 4 hours as needed. Pain will be assessed
by the unit nurses using the appropriate scale for age. Morphine 0.5 mg/kg IV or oxycodone
0.15mg/kg will be administered for NRS, FLACC, or FACES score greater than 4.

Pain Scores will be recorded at 3,6,12 and 24 hours postoperatively with the patient at rest
and during coughing.

On the morning of POD #1, trained research personnel will administer the appropriate survey
of functional recovery. Validated questionnaires to assess postoperative recovery are
available for use in pediatric patients < 12 yrs age (Parents Postoperative Pain Management
(PPPM)) and adult patients (Post Discharge Surgical Recovery (PDSR) scale (10-13)). No
validated survey exists for patients between the ages of 12 -17 and it was decided to extend
the PPPM for use on patients up to and including patients 15 years of age and to use the PDSR
on any patient older than 15.

In addition, parents and patients will fill out a bedside diary in the form of a bingo card
(addendum 2).

Total intravenous and oral opioid (oral oxycodone or other oral opioid given will be
converted to IV morphine equivalents).

Doses, times, and types of all medications administered while in the OR, PACU and inpatient
units will be abstracted from the patient's electronic medical record soon after the patient
is discharged from the hospital to ensure that study protocols were followed. Fentanyl
administration will be analyzed separate from other opioids due to its comparatively
divergent half-life and potency. Other data related to hospital stay such as length of
procedure (surgery start time to surgery stop time), length of time in the OR, length of time
in the recovery room, and length of hospital stay, will be also be collected. Any
complication or opioid-related side effect will also be collected. Data will be kept in an
excel spreadsheet. The spreadsheet will have anonymous patient identifiers and will be kept
in a folder on a password protected hard-drive. Only persons involved in the research study
will have access to the folder.

Inclusion Criteria:

1. Patient age 5-17 years old at time of surgery

2. ASA status 1-2

3. Parent is able to provide informed consent and patient's > age 7 able to give assent

4. Patients scheduled for laparoscopic cholecystectomy

5. Surgery will involve and be limited to laparoscopic cholecystectomy

6. Admission status: 24-hour admission to hospital

Exclusion Criteria:

1. Non-English speaking parents/patient.

2. All emergency laparoscopic cholecystectomies or conversion to an open procedure

3. Patients who will remain intubated or require ICU care postoperatively

4. Significant liver or renal disease

5. Coagulopathy

6. Underlying neurocognitive disorder or developmental delay affecting ability to convey
feelings of pain to medical staff

7. Diagnosis of chronic pain syndrome

8. Active infection over nerve block sites

9. History of allergy to local anesthetic agents or non-steroidal anti-inflammatory drugs
(NSAIDS)

10. Known alcohol or substance abuse within the past 6 months

11. Daily Opioid use

12. ASA class 3 or higher