Assessment of Intercostal Block Scheduling in Preventing Acute Surgical and Post-surgical Pain in Thoracoscopic Surgery

NCT02469610 | Completed Phase 4 Results

• 1 other identifier: CMC-14-0123-CTIL
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

It is well known that chest surgery patients suffer from high level pain in the perioperative period. The transition to thoracoscopic approaches reduced surgical pain. The proper pain control technique for thoracoscopic approaches is still under debate. One of the most popular methods for pain control is these procedures is the Intercostal block. The Intercostal block is usually based upon topical analgesic. In this study the investigators will try to examine the effect on pain control of the timing of Intercostal block of 100 mg BUPIVACAINE. The study is a prospective comparative study. The cohort will be divided into two groups. In the control group patients will have Intercostal block after surgery and in the study group the intercostal block will be given in the beginning of the surgical procedure. All other analgesic treatment during and post-surgery will be the same in both groups. The study will evaluate pain level in the days after the surgery, analgesic medication consumption and relevant morbidity.

Conditions

Chest Pain; Surgery

Keywords

Post surgical pain

Outcome Measures

Primary Outcomes (1)

• Analgesic Use

  The amount of analgesic medication consumption by patients during and after thoracoscopic surgery. the measurement include A. Analgesic usage during the hours of operation and recovery unit (4-8Hr) B. Analgesic usage during postoperative days (first, second, third and fourth for each 24 Hr)

  post operative

Secondary Outcomes (1)

• Visual Analog Pain Scale

  post operative

Study Arms (2)

study

EXPERIMENTAL

In the study group the surgeon will perform an intercostal Bupivacaine block of 100ml over five intercostal spaces which include the operation cuts. The block will be done in the beginning of the surgery right after the insertion of the video camera to the pleural space.

Other: Intercostal block Bupivacaine based

control

OTHER

In the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. this approach is used today in our department.

Other: Intercostal block Bupivacaine based

Interventions

Intercostal block Bupivacaine based OTHER

Intercostal Bupivacaine block of 100ml over five intercostal spaces.

control; study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thoracoscopic surgery candidate.
• Over 18 years old.
• No known allergy to Bupivacaine.
• Patient is able to read understand and singe an inform consent.

You may not qualify if:

• Previous thoracic operation in the same side.

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

CarmelMC

Haifa, Israel

Location

Related Publications (1)

• 1. Regional analgesia for video-assisted thoracic surgery: a systematic review.Steinthorsdottir KJ, Wildgaard L, Hansen HJ, Petersen RH, Wildgaard K. Eur J Cardiothorac Surg. 2013 Nov 27. 2. Postoperative analgesia in video-assisted thoracoscopy: the role of intercostal blockade. Taylor R, Massey S, Stuart-Smith K. J Cardiothorac Vasc Anesth. 2004 Jun;18(3):317-21. 3. The efficacy of intraoperative internal intercostal nerve block during video-assisted thoracic surgery on postoperative pain.Bolotin G, Lazarovici H, Uretzky G, Zlotnick AY, Tamir A, Saute M.Ann Thorac Surg. 2000 Dec;70(6):1872-5. 4. Preventing post-thoracotomy pain syndrome.Khelemsky Y, Noto CJ. Mt Sinai J Med. 2012 Jan-Feb;79(1):133-9. doi: 10.1002/msj.21286. Review. 5. Prevention of chronic pain after surgical nerve injury: amputation and thoracotomy.Buchheit T, Pyati S.Surg Clin North Am. 2012 Apr;92(2):393-407. Review. 6. Paravertebral blocks.Chelly JE. Anesthesiol Clin. 2012 Mar;30(1):75-90. Review. 7. Persistent postoperative pain: where are we now? Niraj G, Rowbotham DJ. Br J Anaesth. 2011 Jul;107(1):25-9. Review.

  BACKGROUND

MeSH Terms

Conditions

Chest Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr LEVY FABER Dan
• Organization: CarmelMC

DANLf@clalit.org.il

97248250289

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 11, 2015
• Study Start: June 1, 2015
• Primary Completion: January 30, 2017
• Study Completion: June 25, 2017
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-04

Locations

IL (1)