Analgesia Clinical Trial
Official title:
A Randomized Comparison Between Perineural Dexamethasone and Perineural Mixture of Dexamethasone-Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Block
Verified date | March 2022 |
Source | University of Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will compare perineural dexamethasone 2mg and perineural mixture of dexamethasone 2mg plus dexmedetomidine 50mcg DX plus DXD as adjuvants to local anesthetics for ultrasound-guided infraclavicular brachial plexus blocks (ICBs). The protocol is designed as a superiority trial and hypothesizes that the mixture of both drugs results in longer block duration. Furthermore, since analgesic and sensory duration can be influenced by the intake of pain medications and surgical trauma to small cutaneous nerves, respectively, motor block duration was selected as the main outcome to better target the action of both adjuvants on the brachial plexus.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 1, 2022 |
Est. primary completion date | March 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - American Society of Anesthesiologists classification 1-3 - Body mass index between 20 and 35 Exclusion Criteria: - Adults who are unable to give their own consent - Pre-existing neuropathy (assessed by history and physical examination) - Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets = 100, International Normalized Ratio = 1.4 or prothrombin time = 50) - Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine = 100) - Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases = 100) - Allergy to local anesthetics (LAs) - Pregnancy - Prior surgery in the infraclavicular region - Chronic pain syndromes requiring opioid intake at home |
Country | Name | City | State |
---|---|---|---|
Chile | Hospital Clínico Universidad de Chile | Santiago | Metropolitan |
Lead Sponsor | Collaborator |
---|---|
University of Chile |
Chile,
Aliste J, Layera S, Bravo D, Fernández D, Jara Á, García A, Finlayson RJ, Tran DQ. Randomized comparison between perineural dexamethasone and dexmedetomidine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2019 Jul 11. pii: rapm-2019-100680. doi: 10.1136/rapm-2019-100680. [Epub ahead of print] — View Citation
Bravo D, Aliste J, Layera S, Fernández D, Leurcharusmee P, Samerchua A, Tangjitbampenbun A, Watanitanon A, Arnuntasupakul V, Tunprasit C, Gordon A, Finlayson RJ, Tran DQ. A multicenter, randomized comparison between 2, 5, and 8 mg of perineural dexamethasone for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2019 Jan;44(1):46-51. doi: 10.1136/rapm-2018-000032. — View Citation
Chong MA, Berbenetz NM, Lin C, Singh S. Perineural Versus Intravenous Dexamethasone as an Adjuvant for Peripheral Nerve Blocks: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2017 May/Jun;42(3):319-326. doi: 10.1097/AAP.0000000000000571. Review. — View Citation
Leurcharusmee P, Aliste J, Van Zundert TC, Engsusophon P, Arnuntasupakul V, Tiyaprasertkul W, Tangjitbampenbun A, Ah-Kye S, Finlayson RJ, Tran DQ. A Multicenter Randomized Comparison Between Intravenous and Perineural Dexamethasone for Ultrasound-Guided Infraclavicular Block. Reg Anesth Pain Med. 2016 May-Jun;41(3):328-33. doi: 10.1097/AAP.0000000000000386. — View Citation
Tran DQ, Bertini P, Zaouter C, Muñoz L, Finlayson RJ. A prospective, randomized comparison between single- and double-injection ultrasound-guided infraclavicular brachial plexus block. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):16-21. doi: 10.1097/AAP.0b013e3181c7717c. — View Citation
Tran DQ, Dugani S, Dyachenko A, Correa JA, Finlayson RJ. Minimum effective volume of lidocaine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):190-4. doi: 10.1097/AAP.0b013e31820d4266. — View Citation
Vorobeichik L, Brull R, Abdallah FW. Evidence basis for using perineural dexmedetomidine to enhance the quality of brachial plexus nerve blocks: a systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2017 Feb;118(2):167-181. doi: 10.1093/bja/aew411. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Motor block duration | The elapsed period in minutes between the ending time of the local anesthetic injection and the time of return of hand and fingers movement | 24-48 hours after block | |
Secondary | Sensory block duration | The elapsed period in minutes between the ending time of the local anesthetic injection and the time of the return of hand and fingers sensation | Time Frame: 24-48 hours after nerve block | |
Secondary | Analgesic block duration | The elapsed period in minutes between the ending time of the local anesthetic injection and the time of the first sensation of pain in the surgical area | 24-48 hours after nerve block | |
Secondary | Block performance time | Sum of: 1- the acquisition time of the ultrasonographic image. and 2- the time to perform the block itself (from the skin anesthesia to the end of local anesthetic injection) | 1 hour before surgery | |
Secondary | Intensity of pain during block procedure | Evaluated with the Numeric Rating Scale for Pain. This scale is graduated from 0 to 10 points. A 0-point score represents the absence of pain, and a 10-points score represents the worst imaginable pain. Patients will be asked to rate their pain verbally with this scale. The blinded assessor will register the score reported. | 1 hour before surgery | |
Secondary | Block onset time | Time required to reach a minimal sensorimotor composite score of 14 points out of a maximum of 16 points. The sensorimotor score is described in outcome 7. | 1 hour before surgery | |
Secondary | Sensory and motor block score | The sensorimotor block will be assessed every 5 minutes until 30 minutes after the end of local anesthetic injection using a 16-point composite score evaluating sensory and motor block of musculocutaneous, medium, radial, and ulnar nerves.
Sensation will be assessed with ice in each nerve territory with a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, the patient can feel touch but not cold; 2= anesthetic block, the patient cannot feel cold or touch. The motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis. Successful blocks at 30 minutes correlate with a final score ( sum of all individual sensory and motor scores) of at least 14 points out of 16. |
30 minutes after the ending time of local anesthetic injection | |
Secondary | Incidence of complete block | Percentage of blocks with a minimal sensorimotor composite score of 14 points out of a maximum of 16 points at 30 minutes after the injection | 30 minutes after the ending time of local anesthetic injection | |
Secondary | Incidence of surgical anesthesia | Ability to proceed with surgery without the need for intravenous narcotics, general anesthesia, rescue blocks or local anesthesia infiltration by the surgeon | 30-60 minutes after the ending time of local anesthetic injection | |
Secondary | Incidence of nerve block side effects | Determined by the presence of paresthesia, local anesthetic systemic toxicity, vascular puncture, Horner syndrome or hoarseness after the block. | 0 minutes after skin disinfection to 30 minutes after the nerve block | |
Secondary | Respiratory depression | Presence of low respiratory rates (lower than 8 breaths per minute) or persistent oxygen requirements (pulse oximetry lower than 90% without supplementary oxygen).
The respiratory rate and pulse oximetry are continuously measured intra- and post-operatively (in the post-anesthetic care unit) as a standard of care with a multiparameter monitor. Alarms are set to alert when predetermined levels are reached |
30 minutes after the nerve block to 2 hours after surgery | |
Secondary | Bradycardia | Defined as a heart rate lower than 50 beats per minute. The heart rate is continuously measured intra- and post-operatively (in the post-anesthetic care unit) as a standard of care with a multiparameter monitor. Alarms are set to alert when predetermined levels are reached | 30 minutes after the nerve block to 2 hours after surgery | |
Secondary | Hypotension | Mean arterial pressure lower than 60 mmHg. The blood pressure is measured intra- and post-operatively (in the post-anesthetic care unit) as a standard of care with a multiparameter monitor. Alarms are set to alert when predetermined levels are reached | 30 minutes after the nerve block to 2 hours after surgery | |
Secondary | Postoperative persistent sedation | Persistent sedation after surgery using Ramsay sedation scale. The scale has 6 points from 1 to 6. A higher score represents a more sedated patient.
1= anxious, agitated or restless; 2= co-operative, oriented and tranquil; 3= responds to command only; 4= brisk response to light pain or loud auditory stimulus; 5= sluggish response to light pain or loud auditory stimulus; 6= no response. |
2 hours after surgery | |
Secondary | Persistent neurologic deficit | Presence of persistent sensory or motor postoperative deficit. The patients will be contacted by telephone and inquired about any sensory or motor deficit in the operated extremity. | 7 days after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05534230 -
Dexmedetomidine for Pain Reduction in CABG
|
N/A | |
Recruiting |
NCT06275698 -
HONEY for the Treatment of POst-Tonsillectomy Pain
|
N/A | |
Recruiting |
NCT04436224 -
Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation
|
Phase 4 | |
Not yet recruiting |
NCT04548323 -
Hypoalgesic Effects of Walking and Running Imagined
|
||
Completed |
NCT06054945 -
Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
|
||
Completed |
NCT04394481 -
Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery
|
Phase 4 | |
Completed |
NCT04690647 -
The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement.
|
N/A | |
Completed |
NCT05034601 -
ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure
|
N/A | |
Completed |
NCT03740815 -
Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection
|
N/A | |
Recruiting |
NCT05454202 -
Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
|
||
Recruiting |
NCT04554186 -
Serratus Anterior Plane Block Versus Thoracic Paravertebral Block.
|
N/A | |
Not yet recruiting |
NCT06393777 -
Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion
|
N/A | |
Suspended |
NCT04860635 -
Safety of F14 Following Total Knee Replacement
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT04519463 -
The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing
|
Early Phase 1 | |
Completed |
NCT02916342 -
Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks
|
Phase 4 | |
Not yet recruiting |
NCT02549118 -
Tenoxicam for Intrapartum Analgesia
|
Phase 2 | |
Completed |
NCT03206554 -
Local Infiltration Analgesia in Total Knee Arthroplasty
|
Phase 2 | |
Not yet recruiting |
NCT02190760 -
Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block.
|
N/A | |
Completed |
NCT01789606 -
Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet
|
Phase 3 | |
Completed |
NCT01299584 -
ULTIVA Post Marketing Surveillance
|
N/A |