Dexmedetomidine Added to Ropivacaine Single Shot vs Continuous Interscalene Nerve Block

NCT05775861 | Recruiting

• 1 other identifier: 2022-2892
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dexmedetomidine; interscalene brachial plexus nerve blocks; Elective ambulatory minor shoulder surgery

Outcome Measures

Primary Outcomes (1)

• Primary endpoint will be the Quality of Recovery (QoR-15) questionnaire score from minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery) at 48 hours postoperative.

  To compare the QoR-15 questionnaire scores at 48 hours postoperative after an elective arthroscopic ambulatory shoulder surgery done solely under interscalene block and superficial cervical plexus block with a single shot of 150 mg isobaric ropivacaine 0.5% with 2 mcg/kg (IBW) of dexmedetomidine (125 mg at the level of the interscalene brachial plexus and 25 mg at the level of the superficial cervical plexus) versus a continuous interscalene brachial plexus block with an initial dose of 150 mg of isobaric ropivacaine 0.5% (125 mg at the interscalene brachial plexus level and 25 mg at the superficial cervical plexus) and a continuous infusion using an infusion pump of 300 mL at a rate of 5 mL/h of isobaric ropivacaine 0.2% for 60 hours. Assessment will be done preoperatively and on postoperative day 1, day 2 (for the primary outcome) and also on day 3.

  72 hours

Secondary Outcomes (14)

• QoR-15 at 24 hours and 72 hours

  24 hours and 72 hours

• Time before the first analgesic request

  From immediate postoperative period to 72 hours postoperative

• Time before the end of sensory block

  From immediate postoperative period to 72 hours postoperative

• Time before the end of motor block

  From immediate postoperative period to 72 hours postoperative

• Patient satisfaction

  72 hours

Study Arms (2)

single shot interscalene brachial plexus with dexmedetomidine added to ropivacaine

EXPERIMENTAL

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

continuous interscalene brachial plexus block with ropivacaine

ACTIVE COMPARATOR

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).

Drug: continuous interscalene brachial plexus block

Interventions

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

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.

single shot interscalene brachial plexus with dexmedetomidine added to ropivacaine

continuous interscalene brachial plexus block DRUG

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).

continuous interscalene brachial plexus block with ropivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old
• ASA status of I-III
• Patients undergoing elective arthroscopic ambulatory shoulder surgery
• Anticipated return home the same day (less than 12 hours in-hospital) in any operating theater of the CIUSSS.

You may not qualify if:

• less than 18 years old
• Patient refusal
• Pregnancy
• Patients with known allergy to local anesthetics
• Contraindication to interscalene brachial plexus nerve block or superficial cervical plexus block: coagulopathy, contralateral phrenic nerve dysfunction, infection at the puncture site, severe chronic obstructive pulmonary disease
• Technical inability to proceed with the interscalene brachial plexus nerve block
• Surgery requiring general anesthesia
• Body weight less than 50 kg
• Patient with no family member or caring adult at home during the first 72h postoperative (contraindication to elastomeric pump)
• Unable to communicate with the investigators, unable to read the questionnaire, unable to keep track and notes of the medication taken at home
• Significant psychiatric or cognitive condition interfering with the ability to provide consent or assessment
• Preexisting neurologic deficits or neuropathy affecting the brachial plexus
• Any contra-indication to same-day surgery identified by the pre-operative clinic such as, but not limited to, any cognitive disorder, any physical limitation other than the one leading to surgery that might impair the patient to take care of himself/herself at home, any severe pulmonary or cardiac disorder, bleeding disorder, etc,
• Any cardiac or pulmonary condition that precludes the risk of bradycardia or hypotension such as but not limited to symptomatic coronary disease, severe aortic stenosis, moderate to severe pulmonary hypertension, congestive heart failure, second or third degree block, pre-existing bradycardia (HR lower than 50), pre-existing hypotension (SBP lower than 100 mmHg), etc.
• History of chronic pain with daily opioid use during the 3 months before surgery

Sponsors & Collaborators

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

Study Sites (1)

CIUSSS de l'Est de l'Ile de Montreal

Montreal, Quebec, H1T2M4, Canada

RECRUITING

MeSH Terms

Conditions

Shoulder Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Ariane Clairoux, MD

  Ciusss de L'Est de l'Île de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariane AC Clairoux, MD, FRCPC

CONTACT

5142226743; ariane.clairoux@umontreal.ca

Nadia NG Godin, MD, PhD

CONTACT

5142523400; ngodin.hmr@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The patient, the anesthesiologist that will perform the block and the operating room staff cannot be blinded for treatment group allocation since the material differs in the 2 groups. We did not want to remain blind at all costs by installing catheters in all participants, with a continuous infusion of saline for the dexmedetomidine group, since the insertion of a catheter is not without risk for the patient and the initial bolus would have been diluted. The nurse staff, anesthesiologists and the research staff evaluating the patient by phone on postoperative days 1,2 and 3 will not be blinded to the patients' study care group allocation because they will also be looking for minor complications that involve the catheter or the infusion pump.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant professor

Model Details: All patients will be first met either at our preoperative investigation clinic or by phone in the days leading to surgery to present the project and obtain consent. Consent will be dynamic and participants will have the possibility to withdraw from the study at all times. A web-based inclusion and randomization form will be provided to the investigators. Randomization will be done in a 1:1 ratio. Envelopes will be made, one for each patient, and will contain the randomization information and in which group they are in: D in the single shot dexmedetomidine added to ropivacaine or R for the continuous interscalene brachial plexus block with ropivacaine.

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: March 20, 2023
• Study Start: August 23, 2022
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

CA (1)