Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02469610
Enrollment
65
Registered
2015-06-11
Start date
2015-06-30
Completion date
2017-06-25
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pain, Surgery

Keywords

Post surgical pain

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.

Interventions

OTHERIntercostal block Bupivacaine based

Intercostal Bupivacaine block of 100ml over five intercostal spaces.

Sponsors

Carmel Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Analgesic Usepost operativeThe 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

MeasureTime frameDescription
Visual Analog Pain Scalepost operativesubjective 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.

Countries

Israel

Participant flow

Participants by arm

ArmCount
Study
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. Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces.
30
Control
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. Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces.
30
Total60

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath10
Overall Studyexclusion criteria21
Overall StudyLost to Follow-up10

Baseline characteristics

CharacteristicControlTotalStudy
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
23 Participants40 Participants17 Participants
Age, Categorical
Between 18 and 65 years
7 Participants20 Participants13 Participants
Age, Continuous67.4 years66 years64.6 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
30 Participants60 Participants30 Participants
Region of Enrollment
Israel
30 participants60 participants30 participants
Sex: Female, Male
Female
12 Participants28 Participants16 Participants
Sex: Female, Male
Male
18 Participants32 Participants14 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 340 / 31
other
Total, other adverse events
0 / 340 / 31
serious
Total, serious adverse events
1 / 340 / 31

Outcome results

Primary

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)

Time frame: post operative

Population: the use of opioids in the operative day (post operative day 0)

ArmMeasureValue (MEAN)Dispersion
StudyAnalgesic Use33.35 MGStandard Deviation 10.31
ControlAnalgesic Use35.32 MGStandard Deviation 13.44
Secondary

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.

Time frame: post operative

Population: Visual Analog pain Scale on the first post-operative day. For each patient we calculate the average score of his answers to the question How do you rate your pain on the Visual Analog pain Scale ? during the first post-operative day.

ArmMeasureValue (MEAN)Dispersion
StudyVisual Analog Pain Scale3.53 units on a scaleStandard Deviation 2.64
ControlVisual Analog Pain Scale3.63 units on a scaleStandard Deviation 2.64

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026