Dexmedetomidine Added to Ropivacaine Single Shot vs Continuous Interscalene Nerve Block

NCT05775861 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-02-20

No results posted yet for this study

Summary

Arthroscopic shoulder surgery is increasingly performed in an outpatient setting and post-operative pain management is often a real challenge as those surgeries are well recognized for their high level of pain which often affects physical rehabilitation. The interscalene block is a largely used anesthetic technique to perform these surgeries whilst avoiding general anesthesia (GA) and to provide postoperative analgesia. However, the painful period often exceeds the duration of a single shot block, thus affecting patient recovery. Some specialized centers use a continuous catheter and elastomeric pump in order to prolong the duration of analgesia. However, several logistical, professional and financial constraints limit the use of these catheters and pumps in a great number of outpatient centers. On the other hand, perineural dexmedetomidine is increasingly used as an adjuvant to improve block onset, analgesia duration and patient satisfaction.

The use of adjuvants such as perineural dexmedetomidine added to a single shot interscalene block appears to be an interesting option to prolong postoperative analgesia without the limitations imposed by a continuous catheter and elastomeric pumps in arthroscopic shoulder surgeries.

Conditions

  • Anesthesia
  • Shoulder Pain
  • Post Operative Pain

Interventions

DRUG

single shot interscalene brachial plexus block group with dexmedetomidine added to ropivacaine group

For the single shot group with dexmedetomidine added to ropivacaine group (Group D), after local analgesia with 3 mL of 1% lidocaine, the block will be performed under ultrasound guidance using an in-plane approach with a 22 G 80-mm ultrasound needle (Pajunk SonoTAP II, Germany). The perineural solution will be pre-mixed in a 30 mL syringe before the realization of the block. A total of 150 mg of ropivacaine 0.5% will be prepared, 125 mg (25mL) will be mixed with a dose of 2 mcg/kg IBW of dexmedetomidine (100 mcg/mL dexmedetomidine hydrochloride; Precedex, Hospira Inc, Lake Forest, IL). The total of 25 mL (125 mg or ropivacaine 0.5%) with dexmedetomidine will be injected perineurally at the level of the roots and a 5 mL (25 mg) will be injected between the sternocleidomastoid muscle and anterior scalene for the superficial cervical plexus block.

DRUG

continuous interscalene brachial plexus block

The block will be performed under ultrasound guidance using an in-plane approach with a 17G Tuohy needle (Arrow FlexBlock). A total of 100 mg (20 mL) of ropivacaine 0,5% will be injected perineurally at the level of the roots using the Tuohy needle. The 19 G arrow catheter will then be introduced through the Tuohy needle and we will leave 4 cm of the catheter perineurally. An additional 25 mg (5 mL) of ropivacaine 0,5% will be injected using the catheter to make sure the catheter is in a correct position. An additional 5 mL (25 mg) of ropivacaine 0.5 % will be injected between the sternocleidomastoid muscle and anterior scalene for the superficial cervical plexus block using an ultrasound in-plane approach with a 22 G 80-mm ultrasound needle (Pajunk SonoTAP II, Germany) or with a standard 25G 1 1/2 inches needle. After the surgery, an infusion of ropivacaine 0,2% at a standard rate of 5 mL/h will be started using an elastomeric pump of 300 mL (Baxter Corporation, Mississauga, Ontario).

Sponsors & Collaborators

  • Ciusss de L'Est de l'Île de Montréal

    lead OTHER

Principal Investigators

  • Ariane Clairoux, MD · Ciusss de L'Est de l'Île de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-23
Primary Completion
2025-01-31
Completion
2025-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05775861 on ClinicalTrials.gov