Nerve BlockEarly Phase 1ICBNNCT03797924
Intercostobrachial Nerve Block (ICBN) for Tourniquet Pain: Is it Necessary?
A Early Phase 1 study testing Receive ICBN with ropivacaine and No ICBN block in people with Nerve Block and Pain, run by University of Florida at 1 site in United States.
Trial summary
In this study the investigators would like to show that when patients undergo upper limb surgery under supraclavicular brachial plexus block, additional blocking of the Intercostobrachial Nerve Block (ICBN) does not affect the incidence or course of tourniquet pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nerve Block, Pain
- What is being tested?
- Receive ICBN with ropivacaine and No ICBN block
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2019to 13 Dec 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) 1-3
- Distal upper extremity surgery with anticipated use of tourniquet
- Outpatient surgery
- Patients who desire regional anesthesia as primary anesthetic
Who cannot join
- ASA 4 or greater
- Allergies to local anesthetic
- Refusal of regional anesthesia
- History of chronic pain syndromes
- Patients who do not desire regional anesthesia as primary anesthetic
Trial locations and contacts
1 site in 1 country.
About this study
In this study the investigators would like to show that when patients undergo upper limb surgery under supraclavicular brachial plexus block, additional blocking of the Intercostobrachial Nerve Block (ICBN) does not affect the incidence or course of tourniquet pain.
Read the detailed description
The ICBN is a cutaneous sensory nerve that supplies the medial aspect of the upper arm. Traditionally this nerve is blocked to alleviate tourniquet pain. The etiology of tourniquet pain is complex and the study team hypothesize that blocking the ICBN has no impact on tourniquet pain. Patients will receive a supraclavicular block and be divided into two groups; ICBN with local anesthetic or ICBN with saline. All patients in this study will receive a supraclavicular block as their primary anesthetic and then be divided into two groups; those who receive ICBN and those who do not. Amount of intraoperative analgesics, conversion to deep sedation or general anesthesia, and onset of time to tourniquet pain will be the primary measures of this study.
- Conditions
- Nerve Block, Pain
- Being tested
- Receive ICBN with ropivacaine, No ICBN block
- Keywords
- Intercostobrachial Nerve Block, Tourniquet Pain, Upper Limb Surgeries
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receive ICBN with ropivacaineDrug
Also called Naropin
ICBN block will be performed using US guidance depositing 10 ml of 0.5% ropivacaine in the plane between pectoralis minor and serratus anterior over the 2nd and 3rd intercostal space.
No ICBN blockBehavioural
The site of injection will be prepped with tinted chlorhexidine
| Study group | Role | What they receive |
|---|---|---|
| ICBN with ropivacaine | Active comparator | Participants will receive ICBN with ropivacaine. In order to blind anesthesia providers in the room and nurses in PACU, the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients. Receives: Drug: Receive ICBN with ropivacaine |
| No ICBN block | Placebo comparator | Participants will have the site prepped, but no ICBN block given. In order to blind anesthesia providers in the room and nurses in PACU, the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients. Receives: Behavioral: No ICBN block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between the 2 groups assessed by the incidence of tourniquet pain reported by the patient on a Descriptor Differential Scale of Pain Intensity (DDSI)
Tourniquet pain defined by the presence of dull or aching pain underneath the tourniquet
Measured: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
Secondary outcomes (4)
Change between the 2 groups depth of anesthesia during surgery to alleviate tourniquet pain as assessed by the American Society of Anesthesiologist (ASA) Continuum of Depth of Sedation definition of general anesthesia and levels of sedation/analgesia.
Determine required depth of anesthesia during surgery to alleviate tourniquet pain
Measured: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
Change between the 2 groups assessed by intraoperative opioid consumption
Determine amount of intraoperative opioid consumption due to tourniquet pain
Measured: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
Change between the 2 groups assessed by time to onset of tourniquet pain
Determine the time to onset of tourniquet pain
Measured: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
Change between the 2 groups in reported severity of tourniquet pain
Determine if ICBN has an affect on the severity of tourniquet pain as assessed by Descriptor Differential Scale of Pain Intensity (DDSI) There are 10 points along which patients can rate their pain intensity to the right and left of each descriptor, so the pain is rated on a 21 point scale for each descriptor. Pain intensity is defined as a mean of the ratings and can range from 0 to 20.
Measured: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start25 Apr 2019
- Primary completion20 Dec 2020
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to receive ICBN with ropivacaine or no ICBN or ropivacaine.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Le-Wendling, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797924
- Sponsor's protocol ID
- IRB201802525
- Other IDs
- OCR19802
- Acronym
- ICBN
- Status last verified
- May 2022
- First submitted
- 1 Jan 2019
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Satsumae T, Yamaguchi H, Inomata S, Tanaka M. Magnesium sulfate attenuates tourniquet pain in healthy volunteers. J Anesth. 2013 Apr;27(2):231-5. doi: 10.1007/s00540-012-1493-4. Epub 2012 Oct 7.
PubMed 23053464Hagenouw RR, Bridenbaugh PO, van Egmond J, Stuebing R. Tourniquet pain: a volunteer study. Anesth Analg. 1986 Nov;65(11):1175-80.
PubMed 3767015Valli H, Rosenberg PH, Kytta J, Nurminen M. Arterial hypertension associated with the use of a tourniquet with either general or regional anaesthesia. Acta Anaesthesiol Scand. 1987 May;31(4):279-83. doi: 10.1111/j.1399-6576.1987.tb02566.x.
PubMed 3591250Crews JC, Cahall M, Behbehani MM. The neurophysiologic mechanisms of tourniquet pain. The activity of neurons in the rostroventral medulla in the rat. Anesthesiology. 1994 Sep;81(3):730-6. doi: 10.1097/00000542-199409000-00027.
PubMed 8092519MacIver MB, Tanelian DL. Activation of C fibers by metabolic perturbations associated with tourniquet ischemia. Anesthesiology. 1992 Apr;76(4):617-23. doi: 10.1097/00000542-199204000-00020.
PubMed 1550287Tschaikowsky K, Hemmerling T. Comparison of the effect of EMLA and semicircular subcutaneous anaesthesia in the prevention of tourniquet pain during plexus block anaesthesia of the arm. Anaesthesia. 1998 Apr;53(4):390-3. doi: 10.1046/j.1365-2044.1998.00301.x.
PubMed 9613307
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intercostobrachial Nerve Block (ICBN) for Tourniquet Pain: Is it Necessary?
- ClinicalTrials.gov ID
- NCT03797924
- Acronym / sponsor ID
- ICBN / IRB201802525
- Conditions
- Nerve Block, Pain
- Keywords
- Intercostobrachial Nerve Block, Tourniquet Pain, Upper Limb Surgeries
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 9 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators would like to show that when patients undergo upper limb surgery under supraclavicular brachial plexus block, additional blocking of the Intercostobrachial Nerve Block (ICBN) does not affect the incidence or course of tourniquet pain.
Detailed description
The ICBN is a cutaneous sensory nerve that supplies the medial aspect of the upper arm. Traditionally this nerve is blocked to alleviate tourniquet pain. The etiology of tourniquet pain is complex and the study team hypothesize that blocking the ICBN has no impact on tourniquet pain. Patients will receive a supraclavicular block and be divided into two groups; ICBN with local anesthetic or ICBN with saline. All patients in this study will receive a supraclavicular block as their primary anesthetic and then be divided into two groups; those who receive ICBN and those who do not. Amount of intraoperative analgesics, conversion to deep sedation or general anesthesia, and onset of time to tourniquet pain will be the primary measures of this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients will be randomized to receive ICBN with ropivacaine or no ICBN or ropivacaine.
| Arm | Type | Receives |
|---|---|---|
| ICBN with ropivacaine | Active comparator | Drug: Receive ICBN with ropivacaineParticipants will receive ICBN with ropivacaine. In order to blind anesthesia providers in the room and nurses in PACU, the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients. |
| No ICBN block | Placebo comparator | Behavioral: No ICBN blockParticipants will have the site prepped, but no ICBN block given. In order to blind anesthesia providers in the room and nurses in PACU, the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) 1-3
- Distal upper extremity surgery with anticipated use of tourniquet
- Outpatient surgery
- Patients who desire regional anesthesia as primary anesthetic
Key exclusion criteria (5 listed)
- ASA 4 or greater
- Allergies to local anesthetic
- Refusal of regional anesthesia
- History of chronic pain syndromes
- Patients who do not desire regional anesthesia as primary anesthetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receive ICBN with ropivacaineAlso: NaropinICBN block will be performed using US guidance depositing 10 ml of 0.5% ropivacaine in the plane between pectoralis minor and serratus anterior over the 2nd and 3rd intercostal space. | Drug | ICBN with ropivacaine |
| No ICBN blockThe site of injection will be prepped with tinted chlorhexidine | Behavioural | No ICBN block |
Primary outcome
Change between the 2 groups assessed by the incidence of tourniquet pain reported by the patient on a Descriptor Differential Scale of Pain Intensity (DDSI)
Time frame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
Tourniquet pain defined by the presence of dull or aching pain underneath the tourniquet
4 secondary outcomes
Change between the 2 groups depth of anesthesia during surgery to alleviate tourniquet pain as assessed by the American Society of Anesthesiologist (ASA) Continuum of Depth of Sedation definition of general anesthesia and levels of sedation/analgesia.
Time frame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
Change between the 2 groups assessed by intraoperative opioid consumption
Time frame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
Change between the 2 groups assessed by time to onset of tourniquet pain
Time frame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
Change between the 2 groups in reported severity of tourniquet pain
Time frame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Results publication: PubMed 23053464Satsumae T, Yamaguchi H, Inomata S, Tanaka M. Magnesium sulfate attenuates tourniquet pain in healthy volunteers. J Anesth. 2013 Apr;27(2):231-5. doi: 10.1007/s00540-012-1493-4. Epub 2012 Oct 7.
- Results publication: PubMed 3767015Hagenouw RR, Bridenbaugh PO, van Egmond J, Stuebing R. Tourniquet pain: a volunteer study. Anesth Analg. 1986 Nov;65(11):1175-80.
- Results publication: PubMed 3591250Valli H, Rosenberg PH, Kytta J, Nurminen M. Arterial hypertension associated with the use of a tourniquet with either general or regional anaesthesia. Acta Anaesthesiol Scand. 1987 May;31(4):279-83. doi: 10.1111/j.1399-6576.1987.tb02566.x.
- Results publication: PubMed 8092519Crews JC, Cahall M, Behbehani MM. The neurophysiologic mechanisms of tourniquet pain. The activity of neurons in the rostroventral medulla in the rat. Anesthesiology. 1994 Sep;81(3):730-6. doi: 10.1097/00000542-199409000-00027.
- Results publication: PubMed 1550287MacIver MB, Tanelian DL. Activation of C fibers by metabolic perturbations associated with tourniquet ischemia. Anesthesiology. 1992 Apr;76(4):617-23. doi: 10.1097/00000542-199204000-00020.
- Results publication: PubMed 9613307Tschaikowsky K, Hemmerling T. Comparison of the effect of EMLA and semicircular subcutaneous anaesthesia in the prevention of tourniquet pain during plexus block anaesthesia of the arm. Anaesthesia. 1998 Apr;53(4):390-3. doi: 10.1046/j.1365-2044.1998.00301.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Le-Wendling, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Receive ICBN with ropivacaine and No ICBN block in people with Nerve Block and Pain, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change between the 2 groups assessed by the incidence of tourniquet pain reported by the patient on a Descriptor Differential Scale of Pain Intensity (DDSI) (time frame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03797924, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.