Continuous Subpleural Infusion of Bupivacaine

Postoperative Pain Clinical Trial

Official title:

A Randomized Controlled Trial of Continuous Subpleural Infusion of Bupivacaine After Thoracoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566838
• Other study ID #: 120104onq
• Status: Completed
• Phase: N/A
• First received: February 21, 2012
• Last updated: December 18, 2017
• Start date: October 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2017
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rationale: For the past 3 years the investigators have routinely used an axial subpleural tunneling technique that del

Study Design: All patients over the age of 18 having an isolated thoracoscopic procedure performed at Inova Fairfax Hospital for therapeutic or diagnostics purposes will be screened. Patients will be excluded if they have: previous ipsilateral thoracic surgery, need for operative pleurectomy or pleurodesis, chronic use of pain medication, sedatives or hypnotics, drug allergies, liver dysfunction, renal dysfunction, history of peptic ulcerative disease, sleep apnea in need of Bipap, severe chronic obstructive pulmonary disease (COPD), inability to consent, or are pregnant. All patients included will be screened, consented, and operated on by the one year anniversary of institutional review board (IRB) approval.

Study Methodology: Eighty-six consented patients will be randomized into the study arm (use of a pain catheter with 0.125% bupivacaine) or the standard of care group (no pain catheter). The primary outcome is the use of narcotic pain medication post-operatively, compared between study groups. Secondary outcomes will include postoperative pain scores, hospital and length of stay.

The On-Q pump delivers local anesthetic to the intercostal space, without leakage elsewhere, creating a functional multi level rib block. Despite positive subjective results, objective data is lacking. The investigators have also noted that some patients develop an annoying short term paresthesia that has been minimized by using lower anesthetic concentrations than described in other publications.

Objectives: To evaluate visual analog pain scores post-operatively up to 30 days post-operative, and to determine any association between pain management and length of stay.

Study Type: A prospective randomized 2-arm study will be performed. Statistical Methodology:

Total amount of narcotic pain medication administered through postoperative day 7, will be compared between the study groups using student's t-tests and Wilcoxon rank-sum tests. Secondary outcomes, overall sum of pain scores through postoperative day 7, then at day 30 post-operatively, hospital length of stay, and overall hospital cost, will also be compared among study groups using student's t-tests and Wilcoxon rank-sum tests.

Description:

Video-Assisted Thoracic Surgery (VATS) has been shown to hasten patient recovery by attenuating the physiologic stress of surgery and decreasing post-operative pain. Despite this approach, incisions in the chest are proportionally more painful than in other parts of the body, and most patients require some form of narcotic pain medication.

Multiple strategies for post-operative pain control have been attempted in thoracic surgery with no obvious superiority of one versus another. Pain catheters have been increasingly used over the past decade in different surgical procedures in order to minimize incisional pain for the first 3 to 7 days after an operation. The published literature is equivocal as to the efficacy of such approach following thoracic surgery with most recent series reporting no benefit in the use of these catheters. Of utmost importance is the placement techniques described thus far, which in our opinion, have been suboptimal.

In order for a pain catheter to work, the infused local anesthetic has to constantly bathe the nerve in question thus preventing painful stimuli from being transmitted. It is hard to dispute the ability of local anesthetic to block pain conduction. Consequently, the success of the intervention is directly dependent on the placement technique to achieve such goal, hence the rationale for our study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients over 18 years of age

• Isolated thoracoscopic procedure for therapeutic or diagnostic purposes

Exclusion Criteria:

• Previous ipsilateral thoracic surgery

• Need for operative pleurectomy or pleurodesis

• Chronic use of pain medication (narcotics or NSAIDS), sedatives or hypnotics

• Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen

• Liver dysfunction (INR > 1.5, albumin < 2.8g/dl, bilirubin > 2mg/dl)

• Renal dysfunction (eGFR < 60ml/min/1.73m2)

• History of peptic ulcerative disease

• Sleep apnea in need of Bipap

• Severe COPD requiring continuous oxygen supplementation

• Inability to consent

• Pregnancy

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Subpleural pain catheter with infusion of 0.125% bupivacaine
Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
• Standard acute pain management
A standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV, neuromuscular reversal agents, and ondansetron 4mg. Fentanyl will be given, as needed, to facilitate patient comfort and extubation. The ASA guidelines for acute pain management in the perioperative period will be followed. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of = 3.

Locations

Country	Name	City	State
United States	Inova Fairfax Hospital	Falls Church	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

References & Publications (6)

Allen MS, Halgren L, Nichols FC 3rd, Cassivi SD, Harmsen WS, Wigle DA, Shen KR, Deschamps C. A randomized controlled trial of bupivacaine through intracostal catheters for pain management after thoracotomy. Ann Thorac Surg. 2009 Sep;88(3):903-10. doi: 10.1016/j.athoracsur.2009.04.139. — View Citation

American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2004 Jun;100(6):1573-81. — View Citation

Chan VW, Chung F, Cheng DC, Seyone C, Chung A, Kirby TJ. Analgesic and pulmonary effects of continuous intercostal nerve block following thoracotomy. Can J Anaesth. 1991 Sep;38(6):733-9. — View Citation

Gurvich EB, Gladkova EV. [The results and outlook of a clinico-epidemiological study of the problem of the carcinogenic hazard in industry]. Gig Tr Prof Zabol. 1992;(7):17-20. Russian. — View Citation

Kaiser AM, Zollinger A, De Lorenzi D, Largiadèr F, Weder W. Prospective, randomized comparison of extrapleural versus epidural analgesia for postthoracotomy pain. Ann Thorac Surg. 1998 Aug;66(2):367-72. — View Citation

Whitson BA, Groth SS, Duval SJ, Swanson SJ, Maddaus MA. Surgery for early-stage non-small cell lung cancer: a systematic review of the video-assisted thoracoscopic surgery versus thoracotomy approaches to lobectomy. Ann Thorac Surg. 2008 Dec;86(6):2008-16; discussion 2016-8. doi: 10.1016/j.athoracsur.2008.07.009. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With and Without 30-Day Pain Medication Usage	The primary outcome will measure narcotics usage from post-operative day 1 through post-operative day 30.	Postoperative day 1 through postoperative day 30
Secondary	7-day Paresthesia	Participants experiencing parasthesia (a tingling or pricking sensation usually caused by pressure or damage to nerves) through postoperative day 7	Postoperative day 1 through day 7
Secondary	Length of Stay	Hospital length of stay for this operation will be recorded and analyzed for each arm of the study.	Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary	30-day Incidence of Parasthesia	30-day incidence of paresthesia (tingling or pricking sensation, usually caused by pressure or nerve damage)	30 days
Secondary	Return to Work	Returned to work in 30 days?	30 days
Secondary	Resumed Physical Activity	Did the patient resume physical activity.	30 days