A Comparison of Ultrasound Guided Transversus Abdominis Plane Nerve Block Techniques
Condition: Crohn's Disease; Inflammatory Bowel Disease; Postoperative Pain
MeSH terms: Crohn Disease; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Postoperative pain can pose significant challenges in the postoperative recovery of patients
      undergoing major colorectal surgery. Traditionally, opioids have played an important role in
      treating postoperative pain. It is well established that opioids are highly effective in
      relieving pain; however opioids are associated with numerous side effects that include
      nausea, vomiting, constipation, ileus, bladder dysfunction, respiratory depression, pruritus,
      drowsiness, sedation, and allergic reaction. These opioid side effects, which range in
      severity, can significantly interfere with discharge home following colorectal surgery.
      Significant interest exists in the use of local anesthetic based regional anesthesia
      techniques as a means to extend the analgesic window for patients undergoing colorectal
      surgery. Specifically, the use of the transversus abdominis plane (TAP) block as an adjunct
      in postoperative pain control has been widely reported in the anesthesia and colorectal
      surgery literature. Historically, the block was performed in a blind fashion with relative
      success and presently the block is typically performed either with ultrasound guidance or
      laparoscopic visualization. While TAP block has shown to be effective in post-operative pain
      control, the techniques used to place the block have not formally been compared.

      The investigators are purposing a prospective, patient-blinded, randomized study of patients
      undergoing major colorectal surgery to compare TAP block under ultrasound guidance versus
      laparoscopic visualization versus no TAP block. The investigators hypothesize that
      laparoscopic-guided TAP block is non-inferior to ultrasound-guided TAP block with respect to
      perioperative pain control and either technique is superior to no TAP. In addition the
      investigators will measure procedural time, any adverse events related to the block, overall
      postoperative analgesic requirement, analgesic duration, postoperative pain scores, length of
      postoperative hospital stay, incidence of postoperative ileus, and overall patient
      satisfaction between the three groups.
    

Detailed description: 
      The proposed study is a patient-blinded, prospective randomized study to compare
      ultrasound-guided block of the TAP versus laparoscopic-guided TAP block versus no TAP block
      in patients undergoing major colorectal surgery. The primary outcome measure is analgesic
      requirement in morphine equivalents in the first 24 hours after surgery. Secondary outcome
      measures include overall postoperative analgesic requirement, postoperative pain scores,
      length of postoperative hospital stay, any adverse events related to TAP block, overall
      perioperative complications in the 30-day postoperative period and overall patient
      satisfaction after major colorectal surgery.

      All groups will receive general anesthesia as the primary mode of anesthesia. Patients
      randomized to one of two treatment arms will also undergo either ultrasound-guided or
      laparoscopic-guided TAP block in the operating room at the conclusion of the procedure.
      Patients randomized to no TAP will not have a TAP block performed but will receive all
      routine intraoperative and postoperative analgesia as deemed appropriate by the anesthesia
      and primary surgical team. A standardized preoperative non-opioid pain regimen will be
      utilized. In the recovery room, short acting opioids for breakthrough pain will be available.
      Opioids will also be administered for rescue if need be. All patients will receive
      postoperative intravenous narcotics via patient controlled analgesia (PCA) device.

      STUDY METHODS

      I. Recruitment

        1. Patients of the investigators will be recruited for this study during their preoperative
           outpatient appointments approximately one week before surgery. The study material packet
           containing the HIPAA and the informed consent form will be emailed to the patient for
           review. Thus the patient will have adequate time to ask questions and consider the study
           prior to scheduled surgery.

        2. The patients will be contacted by one of the study investigators the morning of surgery
           at which time a signed consent will be obtained.

        3. Only patients who have provided their written consent and indicated that they have been
           introduced to the study prior to meeting with the anesthesiologists on the day of
           surgery will be able to participate.

        4. Screening procedures will make sure patients meet all inclusion criteria.

      II. In the preoperative holding area:

        1. An anesthesia investigator assigned to the specific case will assess patients and
           perform a pre-operative anesthesia assessment as per standard protocol at Cedars Sinai
           Medical Center (CSMC). None of this data will be recorded until written informed consent
           is obtained.

        2. Patients will provide a detailed medical history including demographic information
           (e.g., age, weight, height, ethnic origin, smoking history, history of motion sickness,
           history of postoperative nausea and vomiting, as well as chronic analgesic usage). None
           of this data will be recorded until written informed consent is obtained.

        3. Written informed consent will be obtained by one of the investigators.

        4. Patients will be randomized in a blinded fashion by study staff to one of the groups via
           online randomization site, sealedenvelope.com, in a 2:2:1 fashion.

      Group 1 n=100 Ultrasound guided TAP Block Group 2 n=100 Laparoscopic guided TAP Block Group 3
      n=40 No TAP

      III. During the intraoperative period

        1. Standard anesthesia monitors will be applied: automatic blood pressure cuff, three-lead
           electrocardiography, capnography, and pulse oximetry will be used continuously.

        2. Induction of general gnesthesia will be with propofol 2-3 mg/kg & a non-depolarizing
           muscle relaxant (choice will be operator dependent). Maintenance of anesthesia will be
           with an inhalational anesthetic.

        3. The study staff performing randomization will instruct the anesthesiologist or surgeon
           to either block the transversus abdominis plane with ultrasound, laparoscopy, or no
           block.

        4. For the block, a standard weight based dose (bupivacaine 0.25% with epinephrine
           1:200,000, at a 1ml/kg dose) will be used for both ultrasound-guided or
           laparoscopic-guided block.

        5. The block is administered between the costal margin and iliac crest in the anterior
           axillary line at 2 different sites on each side (4 injections total).

        6. For ultrasound-guided TAP block, after the surgeons have completed their portion of the
           procedure, a member of the anesthesia research team will use sterile technique to prep
           the abdomen. The block is then placed bilaterally (at 2 different sites on each side of
           the abdomen) in the anterior axillary line, between the costal margin and iliac crest in
           the intermuscular plane between the internal oblique and transversus abdominis muscles
           using ultrasound guidance.

        7. For laparoscopic-guided TAP block, the attending surgeon will perform the block at the
           conclusion of the procedure under laparoscopic guidance. Bilateral TAP block will be
           performed in the anterior axillary line between the costal margin and iliac crest. After
           the needle is passed through the skin, it is continued until 2 distinct "pops" are felt,
           indicating the needle pierced each of the 2 fascia layers (external oblique and internal
           oblique fascia). After injection of the correct plane, a smooth raised area of fluid
           covered by transversus abdominis muscle is seen with the laparoscope. The laparoscopic
           vision also assures that the preperitoneal plane is not injected and that the injection
           does not go intraperitoneal.

        8. Dose of anesthetics, analgesics, local anesthetics, and IV fluid therapy during the
           operation will be recorded in the anesthesia record as per standard procedure. A copy of
           the sonographic image will be collected for each patient at the conclusion of the block.

        9. Duration of surgery (from skin incision until closure) and anesthesia (from induction of
           spinal until discontinuation of the anesthetic drug) will be recorded in the anesthesia
           record as per standard procedure.

      IV. PACU

        1. Verbal rating scale (VRS) for pain will be assessed by the postanesthesia care unit
           (PACU) nurse upon arrival to recovery room, then every 30min interval until discharge.

           o Requirements for "rescue" analgesic medication will be recorded before discharge.

        2. Any adverse events during the perioperative period will also be noted by PACU RN.

      V. Following completion of surgery (post-operative):

        1. Anesthesia will be discontinued at skin closure.

        2. Patients will be transferred to the recovery room after emergence from sedation

        3. Treatment of surgical pain prior to discharge from the recovery room: moderate-to-severe
           pain (VRS > 7): hydromorphone, 1-1.5 mg IV, moderate pain (VRS of 4-6): hydromorphone
           0.5 - 1 mg IV., mild pain (VRS 2-3), hydromorphone 0.1-0.2 mg IV. Patient pain control
           medication will continue with the initial treatment medication for all subsequent rescue
           doses as needed until recovery room discharge.

        4. Patient nausea, vomiting, or retching will be initially treated with ondansetron 4mg IV.
           Patients unresponsive to ondansetron will receive metoclopramide 10mg IV.

        5. Patient discharge criteria from PACU will include: awake and alert, and has stable vital
           signs.

      VI. Patient evaluation during hospital admission:

        -  VRS for pain assessment will be utilized to assess pain within the first 72 hours
           postoperatively and pain scores will be recorded in the patient chart by the nursing
           staff as per routine CSMC protocol. The average pain scores will be calculated for study
           analysis.

        -  VRS scores along with dose for all opioids will be recorded.

        -  Physical signs and symptoms related to the peripheral nerve block (residual sensory
           blockade) will be noted.

        -  Patient satisfaction with the overall technique will also be queried.

      Pain evaluation recorded by nursing staff as per standard CSMC guidelines:

        -  At PACU every 30 minutes

        -  During admission: 12, 24, 48, and 72 hours postoperatively

      Patient satisfaction with analgesia will be assessed at the time of hospital discharge or
      within 30 days postoperatively by telephone using a patient satisfaction survey.
    

Intervention name(s): Placebo; US TAP Bupivacaine/Epinephrine; Lap TAP Bupivacaine/Epinephrine
Intervention type(s): Other; Drug; Drug
Intervention description(s): The usual intraoperative and postoperative pain control; NO TAP block performed; Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.; Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.
Intervention MeSH terms: Epinephrine; Racepinephrine; Bupivacaine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: transversus abdominis plane block; tap block; regional anesthesia; colorectal surgery