Bilateral Paravertebral Blockade (T7-10) vs. Incisional Local Anesthetic Administration for Pediatric Patients

NCT01380834 | Completed Results DMC

• 1 other identifier: PRO10060554
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative

Keywords

paravertebral nerve blocks; laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Opioids Consumption Via PCA

  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.

  12 hrs after the blocks were done

Secondary Outcomes (2)

• Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS).

  24 hrs after blocks were done or until the patient is discharged

• Opioid Consumption

  24 hrs after blocks were done or until the patient is discharged

Study Arms (2)

treatment group

ACTIVE COMPARATOR

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.

Drug: treatment group

Placebo group

PLACEBO COMPARATOR

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%.

Drug: control group

Interventions

control group DRUG

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%.

Also known as: = Group 2(control group)

Placebo group

treatment group DRUG

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.

Also known as: Group 1 ( treatment group)

treatment group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• pediatric patients scheduled for elective laparoscopic cholecystectomy under general anesthesia
• yrs, female and male
• ASA 1, 2, 3
• more than 30 Kg
• BMI less than 36 (to calculate will use http://www.globalrph.com/bmi.htm )
• the patient must be able to self administer opioids via patient control analgesia (PCA)
• the patient must be able to complete postoperative questionnaires for pain score, pain type, location, patient satisfaction
• the patient will to be admitted for 24 hrs after surgery

You may not qualify if:

• patient refusal
• parental/guardian refusal
• history of coagulopathy, INR more than 1.5, platelets less than 100 000, PT , PTT more than normal value, patient on Coumadin, heparin or low molecular weight heparin ( LMWH)
• local infection at the planned block site
• vertebral anomalies, (e.g. scoliosis)
• BMI more or equal 36
• patient unable to self administer medications via PCA
• allergy to dilaudid, oxycodone, acetaminophen, ropivacaine
• chronic opioid use
• current weight less than 30 kg
• acute pain (pain on day of surgery that requires pain medication)
• pregnancy test positive

Sponsors & Collaborators

• Mihaela Visoiu: lead

Study Sites (1)

Children's Hospital of Pittsburgh, UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (1)

• Visoiu M, Cassara A, Yang CI. Bilateral Paravertebral Blockade (T7-10) Versus Incisional Local Anesthetic Administration for Pediatric Laparoscopic Cholecystectomy: A Prospective, Randomized Clinical Study. Anesth Analg. 2015 May;120(5):1106-1113. doi: 10.1213/ANE.0000000000000545.

  PMID: 25427288 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Dr. Mihaela Visoiu
• Organization: Children's Hospital of UPMC

visoium@upmc.edu

412-692-5260

Study Officials

• Mihaela Visoiu, MD

  CHP of UPMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 27, 2011
• Study Start: November 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 20, 2017
• Results First Posted: May 21, 2015

Record last verified: 2015-05

Locations

US (1)