Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02712151
Recruitment Status : Not yet recruiting
First Posted : March 18, 2016
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Karen Boretsky, Boston Children’s Hospital

Brief Summary:

Laparoscopic cholecystectomy is associated with considerable postoperative pain and surgeon-administered local anesthetic infiltration is the standard practice for achieving post-operative analgesia. However, recent studies have shown that pediatric patients continue to experience significant pain during the first 24 hours.

The investigators plan to conduct a prospective, double-blinded, randomized study where patients will be designated into either a test group receiving an ultrasound-guided transversus abdominis plane (TAP) and rectus sheath (RS) blocks 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 ropivacaine. The anesthesia team and surgical team will both be blinded as well as the research personal in the postoperative period. Patients age 5-17 and American Society of Anesthesiology status I and II undergoing laparoscopic cholecystectomy will be included.

The study hypothesis is that ultrasound-guided peripheral nerve blocks, specifically single shot transversus abdominis plane and rectus sheath blocks, are superior to local wound infiltration during laparoscopic cholecystectomy for decreasing postoperative pain and pain related behavior and facilitating functional recovery.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Abdominal Wall Block Procedure: Surgical infiltration Drug: Sterile saline Drug: Ropivacaine 0.2% Device: Ultrasound Drug: Ropivacaine 0.5% Phase 3

  Hide Detailed Description

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy of Ultrasound-Guided Transversus Abdominis Plane Block for Postoperative Pain Control in Laparoscopic Cholecystectomy: Prospective Randomized Controlled Trial in Pediatric Patients
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Abdominal Wall Block with Ropivacaine 0.2%
Patients 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.
Procedure: Abdominal Wall Block
bilateral TAP and RS blocks.

Procedure: Surgical infiltration
distributed between the 4 laparoscopic port sites.

Drug: Sterile saline
Placebo injection

Drug: Ropivacaine 0.2%
Ropivacaine 0.2% 1.0 ml/kg total in divided doses for bilateral TAP and RS blocks.

Device: Ultrasound
For nerve localization

Active Comparator: Surgical Infiltration with Ropivacaine 0.5%
Patients 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.
Procedure: Abdominal Wall Block
bilateral TAP and RS blocks.

Procedure: Surgical infiltration
distributed between the 4 laparoscopic port sites.

Drug: Sterile saline
Placebo injection

Device: Ultrasound
For nerve localization

Drug: Ropivacaine 0.5%
Ropivacaine 0.5% 0.4 ml/kg total in divided doses distributed between the 4 laparoscopic port sites




Primary Outcome Measures :
  1. cumulative opioid consumption (both intravenous and enteral) during the perioperative period [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. post-operative patient-reported pain scores upon arrival to the post-operative care unit and inpatient unit [ Time Frame: every eight hours thereafter on the hospital floor for total of 24 hours postoperatively ]
  2. post-operative episodes of opioid-related side effects, such as nausea, vomiting, constipation, urinary retention, and pruritis [ Time Frame: 24 hours ]
  3. time to first liquid and/or solid PO intake [ Time Frame: 24 hours ]
  4. time to mobilization out of bed [ Time Frame: 24 hours ]
  5. overall patient functional recovery evidenced by validated patient surveys [ Time Frame: 24 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712151


Contacts
Layout table for location contacts
Contact: Karen Boretsky, MD 617-355-7737 karen.boretsky@childrens.harvard.edu
Contact: Tricia Vecchione, MD 617-355-7040 tricia.vecchione@childrens.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Boston Children's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Karen Boretsky, MD    617-355-7737    karen.boretsky@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
Layout table for investigator information
Principal Investigator: Karen Boretsky, MD Boston Children’s Hospital

Publications of Results:

Layout table for additonal information
Responsible Party: Karen Boretsky, Dr. Karen Boretsky, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02712151     History of Changes
Other Study ID Numbers: IRB-P00022058
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Karen Boretsky, Boston Children’s Hospital:
transversus abdominal plane block

Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents