Does Saline Injection Around Phrenic Nerve Reduce Incidence of Diaphragmatic Paresis Following Interscalene Block?

Phrenic Nerve Palsy Clinical Trial

Official title:

Does Saline Injection Around Phrenic Nerve Reduce Incidence of Diaphragmatic Paresis Following Interscalene Block?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02893228
• Other study ID #: AMNCH-A-SIPPIB
• Status: Completed
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: November 2019

Study information

• Verified date: July 2021
• Source: The Adelaide and Meath Hospital, incorporating The National Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hemi-diaphragmatic palsy is a common undesirable effect of interscalene block, with an incidence of up to 100%. Mechanism of palsy is thought to be related to spread of local anaesthetic anterior to the anterior scalene muscle. We hypothesize that by injecting saline in this anatomical location prior to performing an interscalene block the incidence of phrenic palsy will be reduced.

Description:

Patients will be randomised to either group S (saline group) or group C (conventional group) by computer generated random numbers and allocation will be enclosed in sealed envelope. Anaesthetist performing and/or supervising the block will be the only personnel who will be aware of the randomisation. Patients will be blinded to the study group. Intraoperative management of the case will be done by an anaesthetist blinded to the study group. Outcome measurements will be recorded by study observers blinded to the group allocation.

ISB protocol Following written informed consent, the patient will have routine monitors attached (ECG, Pulse oximeter and non-invasive blood pressure). Intravenous access will be secured and patients will be placed in 45 degree head-up position for the block with head turned to the non-operative side. Intravenous sedation with Midazolam (2 mg) and fentanyl (50 to 100 microgram) will be administered to all patients prior to the block. The ultrasound machine will be positioned on the side opposite to the block. Skin will be prepped with 2% Chlorhexidine (Chloraprep) following which the block will be performed under strict aseptic precautions with the anesthetist wearing a mask and sterile gloves. The high frequency linear probe (sonosite) will be aligned transversely across the neck at the interscalene level to identify C5 and C6 nerve roots. 2% lidocaine will be used for skin infiltration and "stop before block" performed prior to insertion of block needle. In plane posterior approach will be used with a 50 mm short bevel block needle (Braun) advanced through middle scalene muscle. Following this, the technique differs between the two groups.

In group C, the needle tip will then be positioned between C5 and C6 nerve roots. At this location, 15 ml of 0.25% levobupivacaine will be injected in 5 ml increments with intermittent aspiration. The needle tip will not be repositioned unless the patient complaints of paraesthesia.

In group S, at the same level chosen for interscalene block, needle tip will be positioned anterior to anterior scalene muscle. At this location 10 ml 0.9% saline will be injected. This will then be followed by repositioning of needle between roots of C5 and C6 where 15 ml of 0.25% levobupivacaine will be injected in 5 ml increments with intermittent aspiration. The needle tip will not be repositioned unless the patient complaints of paraesthesia.

Intra-operative procedure

Following performance of the block, all patients will receive protocolised general anaesthetic. Anaesthesia will be induced with 2-3 mg per kg of propofol, followed by rocuronium 0.6mg/kg for muscle relaxation. Anaesthesia will be maintained with inhaled sevoflurane (MAC 1 end tidal concentration) along with air and oxygen mixture to deliver an inspired oxygen concentration of 40%. Antibiotics will be given as per hospital protocol prior to incision. In the absence of contraindications, all patients will receive intravenous paracetamol 1g and parecoxib 40 mg as a part of multimodal analgesia regimen. All patients will also receive intravenous dexamethasone 8 mg and ondansetron 4mg for post-operative nausea and vomiting prophylaxis. Further doses of fentanyl in 25 microgram increments will be administered by the anaesthetist if the heart rate increases by more than 15% of baseline values obtained prior to induction. Patients will be reversed by suggamadex. If at least two twitches are present during TOF measurement 2 mg/kg dose will be administered. If less than 2 twitches are present, 4 mg/kg dose will be administered.

Post-operative procedure:

Following transfer to recovery unit, if patient reported pain score by numerical rating score was >3, morphine 2 mg increments will be given intravenously by the recovery staff. This will be repeated every 5 minutes till the pain score is <4. In patients needing more than 10 mg of morphine in the recovery, anaesthetist will be requested to review the patient. Post-operatively, in the absence of contraindications, all patients will be prescribed regular paracetamol 1g, 6 hourly and celecoxib 200 mg, 12 hourly. For breakthrough pain, oxynorm 10 mg as needed once every 4 hours will be prescribed. Anti-emetics (ondansetron 4 mg, 8 hourly and Cyclizine 50 mg, 8 hourly) will be prescribed for all patients to be administered as required. Patient will also be asked about presence or absence of subjective feeling of dypnoea and report satisfaction of overall anaesthetic management (numerical rating scale 0-10) prior to discharge from recovery.

Diaphragm palsy and PFT assessment Diaphragm assessment and bed side spirometry will be done at two time points. First measurement (time point 1) will be done at the baseline as soon as the patient arrives in the induction room. This will be done prior to administration of any sedative agents or regional block. Second assessment (time point 2) will be done post-operatively once the patients are deemed to be ready for discharge from recovery back to the ward.

For diaphragmatic paresis assessment, patients will be placed in supine position and curvilinear ultrasound probe (2-5 MHz) will be used. Diaphragm will be identified as hyperechoic line by subcostal approach using liver and spleen as acoustic windows. Patients will be requested to take deep breaths and M mode will be used to measure the excursion of diaphragm. Diaphragmatic paresis will be documented when there is more than 75% reduction in the excursion compared to baseline or if there was paradoxical movement of the diapragm. Bedside assessment will be done by radiologist blinded to the study group.

Bedside spirometry assessments will be done with patients sitting up. They will be requested to make maximum inspiratory effort and blow as hard and fast in to the device. Best reading from three repeated measurements will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing surgery on shoulder, humerus, or clavicle

Exclusion Criteria:

• Patient refusal

• Allergy to local anaesthesia

• Severe coagulopathy

• Contralateral phrenic nerve palsy

• Local infection

• Moderate to severe pulmonary dysfunction (GOLD II, II, IV)

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Phrenic Nerve Palsy

Intervention

Procedure:
• Saline
At the location chosen for interscalene block the needle tip will be positioned anterior to the anterior scalene muscle. At this point 10ml of 0.9% saline will be injected.

Drug:
• Levobupivacaine
the needle tip will then be positioned between C5 and C6 nerve roots. At this location, 20 ml of 0.25% levobupivacaine will be injected in 5 ml increments with intermittent aspiration. The needle tip will not be repositioned unless the patient complaints of paraesthesia

Locations

Country	Name	City	State
Ireland	Adelaide and Meath Hospital, Incorporating National Children Hospital	Tallagh	Dublin 24

Sponsors (1)

Lead Sponsor	Collaborator
The Adelaide and Meath Hospital, incorporating The National Children's Hospital

Country where clinical trial is conducted

Ireland, 

References & Publications (10)

Cangiani LH, Rezende LA, Giancoli Neto A. Phrenic nerve block after interscalene brachial plexus block. Case report. Rev Bras Anestesiol. 2008 Mar-Apr;58(2):152-9. English, Portuguese. — View Citation

Lee JH, Cho SH, Kim SH, Chae WS, Jin HC, Lee JS, Kim YI. Ropivacaine for ultrasound-guided interscalene block: 5 mL provides similar analgesia but less phrenic nerve paralysis than 10 mL. Can J Anaesth. 2011 Nov;58(11):1001-6. doi: 10.1007/s12630-011-9568-5. Epub 2011 Aug 20. — View Citation

Palhais N, Brull R, Kern C, Jacot-Guillarmod A, Charmoy A, Farron A, Albrecht E. Extrafascial injection for interscalene brachial plexus block reduces respiratory complications compared with a conventional intrafascial injection: a randomized, controlled, double-blind trial. Br J Anaesth. 2016 Apr;116(4):531-7. doi: 10.1093/bja/aew028. — View Citation

Rau RH, Chan YL, Chuang HI, Cheng CR, Wong KL, Wu KH, Wei TT. Dyspnea resulting from phrenic nerve paralysis after interscalene brachial plexus block in an obese male--a case report. Acta Anaesthesiol Sin. 1997 Jun;35(2):113-8. — View Citation

Sinha SK, Abrams JH, Barnett JT, Muller JG, Lahiri B, Bernstein BA, Weller RS. Decreasing the local anesthetic volume from 20 to 10 mL for ultrasound-guided interscalene block at the cricoid level does not reduce the incidence of hemidiaphragmatic paresis. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):17-20. — View Citation

Stundner O, Meissnitzer M, Brummett CM, Moser S, Forstner R, Koköfer A, Danninger T, Gerner P, Kirchmair L, Fritsch G. Comparison of tissue distribution, phrenic nerve involvement, and epidural spread in standard- vs low-volume ultrasound-guided interscalene plexus block using contrast magnetic resonance imaging: a randomized, controlled trial. Br J Anaesth. 2016 Mar;116(3):405-12. doi: 10.1093/bja/aev550. — View Citation

Urmey WF, Grossi P, Sharrock NE, Stanton J, Gloeggler PJ. Digital pressure during interscalene block is clinically ineffective in preventing anesthetic spread to the cervical plexus. Anesth Analg. 1996 Aug;83(2):366-70. — View Citation

Urmey WF, McDonald M. Hemidiaphragmatic paresis during interscalene brachial plexus block: effects on pulmonary function and chest wall mechanics. Anesth Analg. 1992 Mar;74(3):352-7. — View Citation

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. — View Citation

Wennike N, Thompson A. Interscalene block as a precipitant of respiratory dysfunction. Br J Hosp Med (Lond). 2012 Apr;73(4):227. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction	Patient satisfaction scores obtained prior to discharge from recovery will be obtained by numerical rating score 0-10	4 hours
Primary	Rate of diaphragmatic paresis recorded in the post-operative period identified by ultrasound assessment	Diaphragmatic paresis will be documented with greater than 75% reduction in excursion compared to baseline	4 hours
Secondary	FEV1	Forced expiratory volume in 1 second (FEV1)	4 hours
Secondary	FVC	Forced vital capacity (FVC)	4 hours
Secondary	PEFR	Peak expiratory flow rate (PEFR) will be assessed and compared to baseline	4 hours
Secondary	Pain control	Intra-operative fentanyl consumption, post-operative morphine consumption in 24 hours, pain scores (numerical 1-10) on arrival in recovery and at 24 hours post operatively	24 hours post-opertive