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

Primary Purpose

Chest Pain, Surgery

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Intercostal block Bupivacaine based
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Pain focused on measuring Post surgical pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous thoracic operation in the same side.

Sites / Locations

  • CarmelMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

study

control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Visual Analog Pain Scale
subjective patient's pain evaluation according to Visual Analog pain Scale (VAS). Visual Analog pain Scale a 1-10 score of pain. 1 being a lowest level of pain and 10 the worst pain felt by the patient.

Full Information

First Posted
June 9, 2015
Last Updated
April 14, 2019
Sponsor
Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02469610
Brief Title
Assessment of Intercostal Block Scheduling in Preventing Acute Surgical and Post-surgical Pain in Thoracoscopic Surgery
Official Title
Assessment of Intercostal Block Scheduling in Preventing Acute Surgical and Post-surgical Pain in Thoracoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 30, 2017 (Actual)
Study Completion Date
June 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carmel Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Intercostal Bupivacaine block Intercostal block is a procedure during which a local anesthetic is injected to the intercostal space. This space includes the rote of the intercostal nerve. The purpose of the procedure is to block the neuropathic pain that developed due to inflammation and irritation of the nerve and other close structures. Some add steroids to the injection because of their anti-inflammatory effect. Bupivacaine is a local anesthetic. It belongs to a group of medicines called amide- type local anesthetics. It is a well-known medication with many years of documented use in local and regional anesthesia. Bupivacaine binds to the intracellular portion of voltage-gated sodium channels and blocks sodium influx into nerve cells. This block prevents depolarization. The lack of depolarization precludes initiation or conduction of a pain signal can occur. Study Aims This study will try to evaluate the difference in pain control during and post thoracoscopic surgery in patients who had bupivacaine intercostal block before versus after surgery. The study main end point is the amount of analgesic medication consumption by patients during and after thoracoscopic surgery. Secondary end points will include subjective patient's pain evaluation, length of hospital stay and post-operative complication. Inclusion Criteria Thoracoscopic surgery candidate. Over 18 years old. No known allergy to Bupivacaine. Patient is able to read understand and singe an inform consent. Exclusion Criteria Previous thoracic operation in the same side. Study plan The study cohort will be divided into two groups. Study group and control group. Each group will include 30 thoracoscopic surgery candidates. The participants will be randomly assigned to the research groups using a computer selection done by the study team. The participants will not know as to which group they are assigned. All participants will by recruited in the cardio-thoracic surgery department, CARMEL medical center, Haifa, ISRAEL. The basic thoracoscopic surgery approach uses three operation cuts the main Lateral surgical cut is less than 5 cm. Another lower cut of 1-2cmfor the video camera and a lateral subscapular cut of 1-2cm for lung retraction. No rib retractors are being used. During surgery the anesthesiology team is in charge of patient sedation and analgesia according to the local anesthesia department protocol. After surgery the thoracic team is in charge on patient analgesia treatment according to cardio-thoracic surgery department local protocol. Patients will randomized into either study or control group. 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. In the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. All other operation stapes and analgesic treatment will be the same for both groups. Follow up Patient follow up will include the perioperative hospitalization and will continue up to six months after discharge. Follow up will include analgesic medication usage, pain levels, demographic details, Hospital length of stay, post-operative complication and time to resume daily routine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Surgery
Keywords
Post surgical pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intercostal block Bupivacaine based
Intervention Description
Intercostal Bupivacaine block of 100ml over five intercostal spaces.
Primary Outcome Measure Information:
Title
Analgesic Use
Description
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)
Time Frame
post operative
Secondary Outcome Measure Information:
Title
Visual Analog Pain Scale
Description
subjective patient's pain evaluation according to Visual Analog pain Scale (VAS). Visual Analog pain Scale a 1-10 score of pain. 1 being a lowest level of pain and 10 the worst pain felt by the patient.
Time Frame
post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Thoracoscopic surgery candidate. Over 18 years old. No known allergy to Bupivacaine. Patient is able to read understand and singe an inform consent. Exclusion Criteria: Previous thoracic operation in the same side.
Facility Information:
Facility Name
CarmelMC
City
Haifa
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
general discricptive data only
Citations:
Citation
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.
Results Reference
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Assessment of Intercostal Block Scheduling in Preventing Acute Surgical and Post-surgical Pain in Thoracoscopic Surgery

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