Bilateral Paravertebral Blockade (T7-10) vs. Incisional Local Anesthetic Administration for Pediatric Patients
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The objective of this study is to assess the efficacy of paravertebral nerve blocks, single
      shot, with ropivacaine 0.5% for postoperative pain control after elective laparoscopic
      cholecystectomy as compared with incisional administration of same local anesthetic at
      laparoscopic insufflation ports by the surgeon.
    

Detailed description: 
      Pain after laparoscopic cholecystectomy is a result of many mechanisms such as tissue injury,
      local trauma to gallbladder removal, chemical irritation of the peritoneum, pneumoperitoneum.
      Effective analgesia in the immediate post-operative period following laparoscopic
      cholecystectomy is necessary for optimal recovery. Many methods for pain control after
      laparoscopic cholecystectomy have been evaluated, but none of them provided optimal
      postoperative analgesia. When used as a complement to general anesthesia, bilateral
      paravertebral blockade T5-T6 for adult laparoscopic cholecystectomy has been found to improve
      postoperative pain control. Whether this is also the case with pediatric patients is not
      certain. Analgesia from administration of local anesthetic by surgeon at insufflations ports
      is of short duration and may not provide sufficient pain relief. cholecystectomy.

      84 pediatric patients (8-17 yrs old) will be randomly assigned to two groups: Group 1
      (treatment group): 42 patients will have six paravertebral nerve blocks with ropivacaine
      0.5%, and incisional administration of placebo / normal saline at all four laparoscopic
      ports.

      Group 2 (control group): 42 patients will have placebo/normal saline in paravertebral space,
      same amount, and injection at incision sites for all for insufflation ports with ropivacaine
      0.5%.

      Both the anesthesiologist and the surgeon will be blinded to patient randomization.

      Additional postoperative pain control will be provided via patient administered dilaudid PCA,
      for 12 hours after paravertebral block. After PCA is discontinued, the patient will receive
      oxycodone po and dilaudid iv for breakthrough pain.

      Pain assessment will continue until 24 hours after paravertebral block or patient discharge
      if earlier than 24 hours.

      The primary end-point of this research is the amount of dilaudid (ng/kg/min) administered via
      Patient Controlled Analgesia (PCA), 12 hours after administration of ropivacaine 0.5% /normal
      saline in paravertebral space and administration of normal saline/ropivacaine 0.5% at all
      four laparoscopic ports.

      The secondary end points will be also for total amount of fentanyl (mcg/kg), dilaudid
      (mcg/kg), oxycodone (mg/kg) and morphine (mg/kg) (after conversion of above opioids to
      morphine based on opioids potency) used intraoperatively and 24 hours postoperatively (or
      until the patient is discharged, if sooner).

      Postoperative pain scores will be assessed and compared at 4, 8, 12, 18 and 24 hr after
      paravertebral block using Visual Analog Scale (VAS).

      Other secondary end-points will be possible side effects from opioids administration (nausea,
      emesis, itching, and episodes of respiratory depression) and possible complications
      associated with nerve blocks: pleural and vascular punctures, pneumothorax, back pain,
      bruises, and intravascular administration of local anesthetic.
    

Intervention name(s): control group; treatment group
Intervention type(s): Drug; Drug
Intervention description(s): Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.; Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
Other intervention name(s): = Group 2(control group); Group 1 ( treatment group)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: paravertebral nerve blocks; laparoscopic cholecystectomy