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Postoperative PainNCT03628950

Interscalene Versus Combined Infraclavicular-suprascapular Nerve Blocks

A study testing ICSSB group and ISB group in people with Postoperative Pain, run by Fayoum University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this trial is to compare the analgesic efficiency and hemi-diaphragmatic paralysis of the standard ultrasound-guided interscalene (ISB) brachial plexus block with the combined use of costoclavicular approach of infraclavicular brachial plexus block and suprascapular nerve block (ICB-SSB) for patients… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Pain
What is being tested?
ICSSB group and ISB group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteEgypt
Study dates
1 Sep 2018to 30 Sep 2020
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society association (ASA) physical status I to III patients who will be scheduled for an elective arthroscopic rotator cuff repair.

Who cannot join

  • Patient refusal
  • preexisting (obstructive or restrictive) pulmonary disease or low baseline oxygen saturation
  • contraindication to regional anesthesia (coagulopathy, allergy to local anesthetic, sever thrombocytopenia, pre-existing neuropathy in operative limb, infection at puncture site).
  • sepsis
  • hepatic or renal dysfunction.
  • Advanced cardiovascular diseases
  • chronic pain condition requiring the intake of opioids at home.
  • prior surgery in the neck or infraclavicular/suprascapular fossa.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Fayoum University hospital

    El Fayoum Qesm, Faiyum Governorate, 63514

Other trials in Egypt

About this study

Official title: The Analgesic Efficacy and Hemi-diaphragmatic Paralysis Assessment of Combined Infraclavicular-suprascapular Nerve Blocks Versus Standard Interscalene Brachial Plexus Block for Arthroscopic Rotator Cuff Repair

The aim of this trial is to compare the analgesic efficiency and hemi-diaphragmatic paralysis of the standard ultrasound-guided interscalene (ISB) brachial plexus block with the combined use of costoclavicular approach of infraclavicular brachial plexus block and suprascapular nerve block (ICB-SSB) for patients undergoing arthroscopic rotator cuff repair.

Authors hypothesize that the combined use of ICB-SSB could lead to equivalent postoperative analgesic effect to the standard ISB with less hemi-diaphragmatic paralysis.

Read the detailed description

The interscalene block main hindrance is the high risk of ipsilateral phrenic nerve block with sequential hemi-diaphragmatic paralysis.The combined use of conventional paracoracoid infraclavicular block (ICB) and suprascapular block (SSB) was not equivalent to the standard ISB regarding the analgesic efficacy , but has no hemi-diaphragmatic affection for patients undergone shoulder arthroscopic procedures.ICB can be achieved by another approach (costoclavicular) which blocks the brachial plexus at the mid infraclavicular fossa The patients scheduled for an elective arthroscopic rotator cuff repair will be randomly allocated by a computer-gener¬ated table into one of two study groups. The randomization sequence will be concealed in opaque sealed envelopes. The envelopes will be opened by the study investigators just after recruitments and admission to the operation room. Only assessors and data collectors will be blinded to the groups allocations.

Preoperative preparation:

Preoperative investigations will be done according to the local protocol designed to evaluate the patients. It includes complete blood count, blood sugar level, serum urea and creatinine, liver function tests, coagulation profile and electrocardiogram (ECG).

Intraoperative Management of Patients:

After arrival to the induction room, a 20G intravenous catheter will be placed in the upper limb opposite to the surgical site, and intravenous premedication (midazolam 2 mg and fentanyl 50 µg) will be administered to all patients. Supplemental oxygen (nasal cannulae at 2 Lmin-1), standard ASA monitoring (5-lead ECG, noninvasive blood pressure (NIBP), and pulse oximetry) will be applied throughout the procedure. All blocks will be performed under real-time ultrasound guidance (Philips clear vue350, Philips healthcare, Andover MA01810, USA).

The patients in both groups will initially receive superficial cervical plexus block. The block will be performed in supine position with the patients' head turned to the other side. Once the skin is appropriately cleaned and prepared with anti-septic, the high frequency linear array transducer (8-15 megahertz) will be placed over the lateral side of the neck at the midpoint of the posterior border of the sternocleidomastoid muscle(SCM). The transducer is positioned such that the tapering end (posterior border on the ultrasound image) of the SCM is in the center of the screen. The block needle (22-gauge, 50 mm, Stimuplex D®; B Braun, Germany) is then introduced from the posterior aspect through the skin and platysma and 10 ml of local anesthetic(LA) deposited just behind this landmark. Afterthat the patients will receive either ISB or ICB-SSB.

Following completion of the assessments of sensorimotor blocks at 30 min (see below), induction of general anesthesia will be achieved by intravenous propofol 1.5-2 mgkg-1, fentanyl 1 ugkg-1, and atracurium 0.5 mgkg-1. General anesthesia will be maintained by isoflurane 1.5 volume % in 2 lmin-1 oxygen-air mixture 50:50 and atracurium 0.1 mgkg-1 every 30 minutes. All subjects will be placed in the beach chair position slowly, and the surgical procedures will be completed by the same surgical team.

Intraoperatively, if the patient's heart rate or blood pressure exceeded 20% of the preoperative value, a 50-µg bolus dose of fentanyl will be administered. Deliberate hypotension technique will be used to keep systolic blood pressure at 90-100 mmHg range, mean blood pressure at 65-75 mmHg range, and heart rate at 60-70 bpm range by nitroglycerine intravenous infusion at a rate of 1-2 µgkg-1min-1. If excessive unwanted hypotension (systolic blood pressure less than 90 mmHg or mean blood pressure less than 65 mmHg) will be noted, 200 ml ringer acetate fluid bolus will be administered to regain the blood pressure to the desired range with reducing the infusion rate of nitroglycerine or stop it temporarily. Otherwise, 5 mg ephedrine increments will be used to secure save blood pressure readings range. Bradycardia (HR less than 50 bpm) will be corrected by atropine sulphate administration at a dose of 30 µg increments.

Assessment of Sensory and Motor Blockade:

  • The extent of motor and sensory blockade will be evaluated by an anesthesiologist who will not be involved in the brachial plexus block 30 min after local anesthetics administration. Using an alcohol swab, the sensory blockade will be tested on the skin overlying the clavicle (supraclavicular nerves) and the lateral surface of the deltoid (axillary nerve). Each territory will be graded according to a three-point scale using a cold test: 0 = no block; 1 = analgesia (patient can feel touch, not cold); 2 = anesthesia (patient cannot feel touch).
  • Motor function will be tested using shoulder abduction (axillary and suprascapular nerves) and external shoulder rotation (suprascapular nerve) according a three-point scale: 0 = no block; 1 = paresis; 2 = paralysis. blocks will be considered complete if, at 30 min, a global composite score six points (out of a maximum of eight points) will be achieved,5 incidence of complete block 30 minutes after injection will be recoded.

Assessment of hemi-diaphragmatic paralysis (HDP) using Ultrasound:

Ultrasound evaluation of the hemi-diaphragm will be assessed by a blinded trained radiologist. A low-frequency (2 to 5 MHz) curvilinear array transducer will be placed in the coronal plane at the midaxillary line to obtain an intercostal view. At the level of ribs eight to nine on the left and seven to eight on the right, the spleen or liver are centered with the rib shadows on either side. On deep inspiration, caudal descent of the liver or spleen precedes descent of the bright pleural line. The transducer will then be moved in both caudal and cephalad directions to visualize the end-inspiratory and end-expiratory levels of the pleural line, respectively, which will be then marked on the patient's skin. This process will be repeated before, after the chosen regional anesthetic technique and after recovery from general anesthesia in post-anesthetic care unit (PACU) with the patient in the same position. Minimal change signifies no block, but a reduction in this distance represents phrenic nerve block.

Postoperative Evaluation:

After completion of the surgical procedure, the patients extubated after fulfilment of the extubation criteria and then will be transferred to PACU for 2 h assessment. At PACU all patients will receive ketoprofen 100 mg and acetaminophen 1 gram by intravenous infusion over 30 min. Postoperative pain will be rated on a numerical scale ranging (NRS) from 0 (no pain) to 10 (worst imaginable pain) at 1-hr at PACU then at 4, 8, 12, and 24 hours postoperatively. The patients discharged to ward after fulfilment of discharge criteria and modified Aldrete score ≥9. ketoprofen 100 mg/12 h and acetaminophen 1 gram/8 h by intravenous infusion over 30 min will be continued for 48 h as parts of the postoperative pain control policy of the institution. Assessment of postoperative analgesia duration by recording the time of first request of analgesia. The duration of anesthesia time (defined as the time between the end of the local anesthetic injection for brachial plexus block and the postoperative administration of analgesic agents) will be recorded. Patients with NRS>5 will receive morphine sulphate IV at a bolus dose of 2-5 mg increments with maximum dose of 20 mg at 4 hours or 40 mg at 24 hours. Cumulative and interval amount of morphine consumption in 24 h will be recorded.

Being tested
ICSSB group, ISB group
Keywords
Interscalene block, Postoperative analgesia, Suprascapular nerve block, Infraclavicular nerve block, Arthroscopic rotator cuff repair, Hemi-diaphragmatic paralysis
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICSSB groupProcedure or surgery

    Also called Infraclavicular suprascapular block group

    At supine position with abducted limb, the probe of ultrasound will be translocated in costoclavicular space; the subclavian artery will be identified. The three cords of the brachial plexus will be visualized lateral to the artery. By using an in-plane technique and a cephalad-to-caudate direction, the block needle will be advanced until its tip will be in the middle of three cords and 10 mL of 0.25 % bupivacaine Hydrochloride will be injected. Then at lateral decubitus position, by using in-plane technique the probe will be translocated in suprascapular fossa, lateral-to-medial direction, the block needle will be advanced until its tip in the floor of the suprascapular fossa ventral to the fascia of the supraspinatus muscle and 10 mL of 0.25 % bupivacaine Hydrochloride will be injected .

  • ISB groupProcedure or surgery

    Also called Interscalene group

    The probe of ultrasound will be applied in lateral side of the neck at the level of the cricoid cartilage to obtain a view of the three hypoechoic structures which represent the roots of the brachial plexus. Using an in-plane technique and a lateral to-medial direction, the block needle will be advanced until its tip will be positioned under the prevertebral fascia between the two most superficial hypoechoic structures and 10 mL of 0.25 % bupivacaine Hydrochloride will be injected at level of C5-6 and another 10 ml of 0.25 % bupivacaine Hydrochloride will be injected at level of C7-8.

Study groups in NCT03628950
Study groupRoleWhat they receive
ICSSB groupActive comparatorinfraclavicular suprascapular nerve block administered group
Receives: Procedure: ICSSB group
ISB groupActive comparatorinterscalene nerve block administered group
Receives: Procedure: ISB group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The cumulative morphine consumption at first 24 hours postoperatively.

    in milligram

    Measured: 24 hours after recovery from general anesthesia

Secondary outcomes (38)
  1. Assessment of hemidiaphragmatic paralysis

    By using abdominal ultrasonography examination

    Measured: 5 minutes before intervention

  2. Assessment of hemidiaphragmatic paralysis

    By using abdominal ultrasonography examination

    Measured: 5 minutes after intervention

  3. Assessment of hemidiaphragmatic paralysis by abdominal ultrasound examination

    By using abdominal ultrasonography examination

    Measured: 10 minutes after recovery from general anesthesia

  4. Assessment of postoperative pain

    using numerical rate scale (NRS)(where 0=no headache and 10 = worst imaginable headache )

    Measured: 1 hour after recovery from general anesthesia

  5. Assessment of postoperative pain

    using numerical rate scale (NRS)(where 0=no headache and 10 = worst imaginable headache )

    Measured: 4 hours after recovery from general anesthesia

  6. Assessment of postoperative pain

    using numerical rate scale (NRS)(where 0=no headache and 10 = worst imaginable headache )

    Measured: 8 hours after recovery from general anesthesia

  7. Assessment of postoperative pain

    using numerical rate scale (NRS)(where 0=no headache and 10 = worst imaginable headache )

    Measured: 12 hours after recovery from general anesthesia

  8. Assessment of postoperative pain

    using numerical rate scale (NRS)(where 0=no headache and 10 = worst imaginable headache )

    Measured: 24 hours after recovery from general anesthesia

  9. Assessment of postoperative pain

    using numerical rate scale (NRS)(where 0=no headache and 10 = worst imaginable headache )

    Measured: 48 hours after recovery from general anesthesia

  10. Interval morphine consumption dose

    in milligram

    Measured: at 2 hours after recovery from general anesthesia

  11. Interval morphine consumption dose

    in milligram

    Measured: at 4 hours after recovery from general anesthesia

  12. Interval morphine consumption dose

    in milligram

    Measured: at 8 hours after recovery from general anesthesia

  13. Interval morphine consumption dose

    in milligram

    Measured: at 12 hours after recovery from general anesthesia

  14. Interval morphine consumption dose

    in milligram

    Measured: at 24 hours after recovery from general anesthesia

  15. Interval morphine consumption dose

    in milligram

    Measured: at 48 hours after recovery from general anesthesia

  16. Incidence of complete sensory block

    using alcohol swab according to three point scale where 0= no block 1=analgesia (patient can feel touch not cold) 2=anesthesia (patient cannot feel touch)

    Measured: 30 minutes after end of local anesthetic injection

  17. Incidence of complete motor block

    using shoulder abduction and external rotation according to three point scale where 0= no block 1=paresis 2=paralysis

    Measured: 30 minutes after end of local anesthetic injection

  18. Intraoperative fentanyl dose consumption

    In microgram

    Measured: At the end of surgical procedure

  19. Incidence of nausea

    Opioid-related side effect

    Measured: 24 hours postoperative

  20. Incidence of vomiting

    Opioid-related side effect

    Measured: 24 hours postoperative

  21. Incidence of pruritus

    Opioid-related side effect

    Measured: 24 hours postoperative

  22. Incidence of excessive sedation

    Opioid-related side effect

    Measured: 24 hours postoperative

  23. Incidence of respiratory depression

    Opioid-related side effect

    Measured: 24 hours postoperative

  24. Incidence of urine retention

    Opioid-related side effect

    Measured: 24 hours postoperative

  25. time to first rescue analgesia

    in minutes

    Measured: from recovery of general anesthesia up to 24 hours postoperativly

  26. duration of the surgical procedure

    in minutes

    Measured: At the end of surgical procedure

  27. performance time of the intervention

    time from skin disinfection until the end of local anesthetic injection

    Measured: 1 minute immediately after end of local anesthetic injection

  28. Incidence of vascular puncture

    potential adverse events from intervention

    Measured: within 3 seconds during performance of the blocks

  29. Incidence of local anesthetic toxicity

    potential adverse events from intervention

    Measured: 30 minutes after performance of the blocks.

  30. Incidence of paresthesia

    potential adverse events from intervention

    Measured: within 1 second during performance of the blocks

  31. Incidence of Horner syndrome

    potential adverse events from intervention

    Measured: 30 minutes after performance of the blocks.

  32. Incidence of hoarseness of voice

    potential adverse events from intervention

    Measured: 30 minutes after performance of the blocks.

  33. Age

    in years

    Measured: 6 hours before intervention

  34. weight

    in kilogram(kg)

    Measured: 6 hours before intervention

  35. height

    in meters(m)

    Measured: 6 hours before intervention

  36. body mass index

    in kg/m square

    Measured: 6 hours before intervention

  37. Assessment of patients' satisfaction score for postoperative analgesia

    poor=0; fair=1; good=2; excellent=3

    Measured: after 72 hours postoperative

  38. Assessment of surgeon's' satisfaction score

    poor=0; fair=1; good=2; excellent=3

    Measured: At the end of surgical procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2018
  2. Study start1 Sep 2018
  3. Primary completion31 Aug 2020
  4. Study completion30 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03628950
Sponsor's protocol ID
D165
Status last verified
Mar 2022
First submitted
21 Jul 2018
Last updated
16 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ullah H, Samad K, Khan FA. Continuous interscalene brachial plexus block versus parenteral analgesia for postoperative pain relief after major shoulder surgery. Cochrane Database Syst Rev. 2014 Feb 4;2014(2):CD007080. doi: 10.1002/14651858.CD007080.pub2.

    PubMed 24492959
  • Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.

    PubMed 2006740
  • Aliste J, Bravo D, Finlayson RJ, Tran DQ. A randomized comparison between interscalene and combined infraclavicular-suprascapular blocks for arthroscopic shoulder surgery. Can J Anaesth. 2018 Mar;65(3):280-287. doi: 10.1007/s12630-017-1048-0. Epub 2017 Dec 19.

    PubMed 29270914
  • Tran DQ, Elgueta MF, Aliste J, Finlayson RJ. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):32-38. doi: 10.1097/AAP.0000000000000529.

    PubMed 27941477
  • Karmakar MK, Sala-Blanch X, Songthamwat B, Tsui BC. Benefits of the costoclavicular space for ultrasound-guided infraclavicular brachial plexus block: description of a costoclavicular approach. Reg Anesth Pain Med. 2015 May-Jun;40(3):287-8. doi: 10.1097/AAP.0000000000000232. No abstract available.

    PubMed 25899958

Questions about this trial

What is this clinical trial studying?

A study testing ICSSB group and ISB group in people with Postoperative Pain, run by Fayoum University Hospital at 1 site in Egypt.

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 1 inclusion and 8 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 16 Mar 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

The cumulative morphine consumption at first 24 hours postoperatively. (time frame: 24 hours after recovery from general anesthesia). 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 NCT03628950, which also lists 5 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 16 Mar 2022.

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