Comparison of Bilateral Thoracic Paravertebral Block to Thoracic Epidural Analgesia for Post Operative Analgesia in Patients Undergoing Abdominal Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Pain following abdominal surgery is managed with the use of thoracic epidural analgesia (TEA)
      where the epidural is inserted in the spine at the level of scapula The risks due to TEA
      include difficulty with insertion, failure in up to 40% of patient in the perioperative
      period, fall in blood pressure and a rare devastating complication of paralysis either due to
      bleeding or infection. Injury to spinal cord is also a feared complication. Therefore
      alternative techniques need to be evaluated. Paravertebral block (PVB) has been documented to
      provide pain relief following abdominal surgery using an earlier technique which posed the
      risk of puncture of the covering to the lung (pleura) resulting in pneumothorax. The current
      technique involves the use of curled catheters inserted using ultrasonography to lie outside
      the pleura where the nerves travel thus reducing the chances of pneumothorax and catheter
      migration. Objective of the current study is to compare the efficacy and safety of bilateral
      PVB with TEA. Patients undergoing bowel surgery will be randomized to receive thoracic
      epidural analgesia or bilateral thoracic paravertebral blocks. Pain scores during rest and
      coughing, failure and complication rates will be compared between the two groups.

      Objective:

      The objective of the investigators is to determine whether ultrasound (US)-guided bilateral
      thoracic paravertebral blocks (PVB) using curled catheter provides effective post-operative
      analgesia as compared to thoracic epidural analgesia in patients undergoing open abdominal
      bowel surgeries.

      The primary outcome of this study will be the pain scores over the first 24 hours following
      open bowel surgeries.

      Secondary outcomes include

        1. Analgesic consumption in the perioperative period,

        2. Block related data (block performance time, success rate, extent of sensory block,
           complications)

        3. Hemodynamic parameter every 6 hourly

        4. Incidence of side effects like nausea and pruritus scores, time to return of bowel
           activity

      Hypothesis

      Null Hypothesis: Primary.

      Paravertebral blocks provide equal analgesia in the early postoperative period (first 24
      hours of surgery) as compared to thoracic epidural analgesia in patients undergoing bowel
      surgeries by laparotomy.

      Secondary

        1. The analgesic consumption between PVB and TEA is not different during the first 24 hours
           following surgery

        2. The block performance time, success rate and extent of sensory block with PVB are not
           different from that of TEA.

        3. Side effects and complications following bilateral PVB are not different from those
           occurring after TEA
    

Detailed description: 
      A total of 70 patients with ASA physical status 1 to 3, scheduled for elective bowel surgery
      by laparotomy and deemed suitable to receive either thoracic paravertebral or epidural
      analgesia will be included in the study. Recruitment will take place in the preoperative
      clinic. Written informed consent for the participation in the study will be obtained at the
      visit to the preadmission clinic or in the preparation area at least 2 hours prior to the
      surgery. They will be randomized to one of two groups prior to the block procedure using a
      closed envelope system. All patients will be educated regarding the VRS scores on a scale of
      0 to 10 where 0 is no pain and 10 is the worst pain ever experienced. All patients will
      receive perioperative multimodal analgesia using naproxen, gabapentin and acetaminophen.

      All blocks will be performed in the block room using standard monitoring, sterile precautions
      and titrated intravenous sedation with fentanyl and midazolam. During block performance one
      anesthetist and one assistant will be present. Due to the necessity of handling the equipment
      these staff will not be blinded. All patients will receive supplemental oxygen.

      Group 1: Group 1 will receive a catheter congruent TEA. The catheters will be inserted using
      ultrasound to assess level as well as the best space to insert the epidural catheter between
      T7 and T9. The epidural space will be identified using the loss of resistance technique.
      After a test dose to rule out intravascular and intrathecal placement of the catheter using
      3mL of 2% lidocaine with 5mcg/mL of epinephrine, the initial block will be made with 0.25%
      bupivacaine 5 mL followed by 3 mL aliquots administered every 5 minutes to establish a block
      between T8 and T12. An infusion will be started at 8 mL/hour with 0.1 % bupivacaine with 10
      microgram/mL of dilaudid and continued for 72 hours. Additional nurse administered boluses of
      5-10mL of the standard solution will be allowed via the epidural catheter every 6hourly if
      needed for pain control followed by an increase in the basal infusion rate up to a maximum of
      14mL/hr. Patients will be allowed to self-administer additional boluses of 3mL of the
      standard infusate every 20minutes (PCEA) as per the standard practice at this hospital. Time
      to initiate the block and the failures will be documented. If the block fails, patients will
      receive intravenous PCA with dilaudid and the patient will be dropped out of the study for
      efficacy data.

      Group 2 will have bilateral PVB catheters inserted using the ultrasound. Patients will be in
      prone position and will receive intravenous sedation similar to Group 1. The T8 spine will be
      identified and marked counting from the lumbar area. A high-frequency linear ultrasound probe
      will be positioned in the T8/9 intercostal space with the transverse process and pleura in
      the field as well as the internal intercostal membrane. (about 2.5 cm lateral to the spinous
      process) Using ultrasound guidance and an in-plane approach, a 17 gauge Tuohy needle
      connected to 15 mL of 0.5% ropivacaine via an extension tubing will be inserted to puncture
      the internal intercostal membrane. Injection of local anesthetic will push the pleura away,
      which will be the end point of needle position (the current standard technique in the the
      investigators institution). A curved pigtail catheter will be inserted while observing its
      delivery extrapleurally and further 5mL of local anesthetic will be injected while observing
      further movement of pleura. A similar procedure will be done on the contralateral side at the
      same level. The catheter will be secured to the skin and covered with dermabond and tegaderm.
      Following this, 0.2% ropivacaine will be infused at a rate of 7 mlLhr via each catheter for
      the next 72 hours post-operatively. They will also receive intravenous patient controlled
      analgesia with dilaudid at a dose of 0.2mg with a lock out of 6 mins. Additional nurse
      administered boluses of 5-10mL of ropivacaine 0.2% via the paravetebral catheters will be
      permitted every 6 hourly to the side of maximal pain. The position of the catheter will be
      confirmed on the routine post-operative chest x ray following the injection of contrast
      (Isovue: 2 mL). The sensory block extent will be documented at 15 minutes after the initial
      injection and prior to moving the patient to the OR. Time to initiate the block and the
      failure rate will be documented.

      US image of paravertebral space before and after LA injection (IIM: internal intercostal
      membrane; TP: transverse process; LA: local anesthetic)

      As soon as the arterial line is inserted in the operating room for monitoring purposes, 10mL
      of blood will be collected for measuring plasma ropivacaine levels. This measurement will be
      repeated on arrival in the PACU along with routine postoperative arterial blood gas analysis.
      Plasma ropivacaine level will be measured on postoperative day 1 at 6AM with the blood drawn
      along with routine postoperative blood work (venous sample)

      Cases with a failure to establish a block 30 minutes after local anesthetic injection will be
      considered as block failure and the patient will be excluded from the efficacy part of the
      study. These patients will receive intravenous patient controlled analgesia. Once the
      effectiveness and level of the block is confirmed the patient will be moved to the operating
      room for the surgery under standardized general anesthesia using fentanyl 2-3µg/Kg, propofol
      2 mg/kg and rocuronium 0.8-1.0 mg/kg for intubation followed by maintenance with desflurane
      in air-oxygen mixture. Vasopressors (Ephedrine and phenylephrine) will be administered as
      needed to control hemodynamics and the total dose used will be recorded.

      The patients will be assessed for pain during rest and coughing/activity immediately after
      the surgery, every 15 minutes for first 2 hrs and 6 hourly thereafter until 24 hours after
      the removal of epidural or block catheters. Patients whose VRS scores are higher than 5/10 in
      PACU, apart from getting a bolus in the epidural or PVB may also receive IV Hydromorphone 0.2
      mg every 5 minutes till pain subsides to a score of 3/10. Nausea will be documented using a
      categorical scale (none, mild, moderate and severe), pruritus scores will be recorded every
      12 hours (categorical scale, none, mild, moderate and severe). Time to onset of bowel sounds,
      time to first flatus and time to first bowel movement would also be recorded with time 0
      being the arrival time in PACU. Post-operative hemodynamic changes, blood pressure and urine
      output will be documented every 6 hours. Duration of significant hypotension will be computed
      from the nursing chart, significant hypotension being systolic BP less than 90 mm Hg. Patient
      satisfaction will be documented on a visual analogue scale where 0 is totally dissatisfied
      and 100 is totally satisfied. Adverse events such as local anesthetic toxicity, wound
      infection, dehiscence, urinary retention, cognitive dysfunction and neurological deficits
      will be prospectively collected. The failure rate of both the techniques and the number of
      attempts will also be recorded.

      This is an open label study to document the effectiveness of bilateral PVB in bowel
      surgeries. The investigators plan to do a double blind study following the present study if
      the results are encouraging. The second concern is that 2 different local anesthetics are
      used for the 2 limbs but at equianalgesic concentrations for the infusion.
    

Intervention name(s): Thoracic epidural analgesia; Bilateral Paravertebral block
Intervention type(s): Drug; Procedure
Other intervention name(s): Thoracic Epidural Anesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thoracic epidural analgesia; Paravertebral block; pain; postoperative