Dexmedetomidine Added to Ropivacaine Single Shot vs Continuous Interscalene Nerve Block

NCT ID: NCT05775861

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-23
• Study Completion Date: 2025-06-30

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.

Detailed Description

A growing number of arthroscopic shoulder surgeries are performed in an ambulatory setting. For these patients, postoperative pain management is an important factor for analgesia and optimal rehabilitation. Peripheral nerve blocks, and more particularly the interscalene brachial plexus block (ISB), is the method of choice to provide adequate surgical conditions and satisfactory postoperative pain control for shoulder surgeries. Even before the advent of ultrasound guidance , interscalene blocks resulted in a high level of patient satisfaction, fewer post-operative complications and a reduction of hospital stay compared to general anesthesia.

Shoulder surgeries are well recognized to cause severe postoperative pain, mainly in the first 48h, and the use of a single shot interscalene block (SSISB) is limited by its duration of action, which often fails to cover the duration of postoperative analgesia beyond 24 hours.

On the other hand, ultrasound-guided continuous interscalene blocks (CISB) have shown a significant reduction of pain compared to single shot interscalene blocks. However, CISB are limited by many logistical problems which make their use difficult in most ambulatory centers. Indeed, catheter placement is often a technically challenging procedure and accidental catheter removal is a complication that limits their usefulness. However, when the necessary technical resources and medical expertise is available, CISB have been associated with a superior level of analgesia, reduction of opioid consumption, improvements in rest and dynamic pain, and lower instances of postoperative nausea and vomiting than SSISB in major shoulder surgery. A recent study has demonstrated that automated intermittent boluses did not provide better analgesia nor reduced rescue opioid consumption compared to continuous infusion of ropivacaine despite both groups describing insufficient pain relief.

The persistence of pain despite the use of SSISB or CISB has lead several anesthesia teams to use adjuvants to improve the effect and duration of analgesia. Over the years, several adjuvants have been administered to enhance the brachial plexus block onset and duration. Thus, intravenous dexamethasone administered at the time of performing ISB is widely used to improve the duration of analgesia following shoulder surgeries. In addition to the benefits already provided by the addition of intravenous dexamethasone, there is also an added value to perineural dexmedetomidine in order to accelerate the onset of motor and sensory block, extend the duration of the block and reduce the pain score 14 hours postoperatively in elective shoulder surgery.

The combination of intravenous or perineural dexmedetomidine, an α-2 adrenoceptor agonist, with ropivacaine prolongs the duration of SSISB analgesia and reduces opioid consumption postoperatively without prolonging the duration of motor blockade during outpatient shoulder surgeries. Patients undergoing elective shoulder surgery under general anesthesia with perineural dexmedetomidine added to ropivacaine for interscalene block had a faster sensory and motor block onset, an increased duration of nerve blockade and improved postoperative pain up to 14h after the block. Even when a peripheral nerve block is used as the primary anesthetic, SSISB with perineural dexmedetomidine added to ropivacaine in arthroscopic rotator cuff repair has shown lower pain and improved patient satisfaction within 48 h postoperatively. The perfect perineural dexmedetomidine dose should provide optimal analgesia with minimal side effects such as hypotension and bradycardia. Over the years, it has been used in wide-ranging doses and 2 mcg/kg seems to be the optimal dose in SSISB for arthroscopic shoulder surgery to obtain a suitable duration of analgesia. A recent meta-analysis demonstrates the safety of perineural dexmedetomidine as well as its effectiveness during brachial plexus block to accelerate the onset of action and prolong the duration of analgesia. Indeed, no neurological complications or neurotoxic symptoms were reported in patients who received perineural dexmedetomidine.

Rationale for this study:

The addition of dexmedetomidine to ropivacaine for SSIB could improve the duration of postoperative analgesia and patient satisfaction for arthroscopic shoulder surgeries without the limitations and potential complications of an CISB catheter and elastomeric pump. Moreover, the use of a catheter is a complex procedure compared to a single injection and thus limited in some centers due to logistical limitations. Therefore, SSISB with perineural dexmedetomidine could be an interesting alternative to perform shoulder surgeries in centers where the use of a continuous catheter is limited by technical, professional or financial resources. Ultimately, this improvement in postoperative analgesia could lead to early patient mobilization, better physical rehabilitation and improved patient satisfaction. This study will focus on recovery, to better understand patient outcomes and experiences as a whole, in this era of personalized medicine and patient oriented research.

Methods: A predetermined sample size of patients of more than18 years old, ASA status I-III scheduled to undergo elective minor ambulatory shoulder surgery are included. Patients with known allergy to local anesthetics, contraindication to interscalene brachial plexus nerve block or superficial cervical plexus block will be excluded. The premedication and peripheral nerve block technique will be standardized for both groups. Patients will be randomized to receive either a single shot interscalene block with 150 mg of isobaric ropivacaine 0.5% (125 mg at the interscalene brachial plexus level and 25 mg at the superficial cervical plexus) with 2 mcg/kg (IBW) of dexmedetomidine or a continuous interscalene 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 an infusion using an elastomeric pump of 300 mL at a rate of 5 mL/h of isobaric ropivacaine 0.2% for 60 hours. The primary endpoint will be the Quality of Recovery (QoR-15) questionnaire at 48h. The secondary endpoints will be: QoR-15 at 24h and 72h, time before the first analgesic request, time before the end of sensory block, time before the end of motor block, patient satisfaction, total post-operative opioid consumption, major and minor complications.

Study design: Prospective, randomized controlled trial.

Subject population: Adult patients scheduled to undergo elective arthroscopic ambulatory shoulder surgery

Sample size: 96

Study duration: 12 months

Study center: CIUSSS de l'Est de l'Ile de Montréal, Montreal, QC, Canada

Adverse Events: None expected

Subvention: applications to the Canadian Society of Anesthesia as well as to the Foundation of the Association of the Anesthesiologists of Quebec and to the department of anesthesiology of the UdeM will be proposed within the coming year 2021-2022.

Conditions

Anesthesia; Shoulder Pain; Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single shot interscalene brachial plexus with dexmedetomidine added to ropivacaine

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

continuous interscalene brachial plexus block with ropivacaine

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).

Group Type: ACTIVE_COMPARATOR

continuous interscalene brachial plexus block

Intervention Type: 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).

Interventions

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.

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ciusss de L'Est de l'Île de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Ariane Clairoux

MD, Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ariane Clairoux, MD

Role: PRINCIPAL_INVESTIGATOR

Ciusss de L'Est de l'Île de Montréal

Locations

CIUSSS de l'Est de l'Ile de Montreal

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ariane AC Clairoux, MD, FRCPC

Role: CONTACT

ariane.clairoux@umontreal.ca

5142226743

Nadia NG Godin, MD, PhD

Role: CONTACT

ngodin.hmr@ssss.gouv.qc.ca

5142523400 ext. 3193

Facility Contacts

Philippe PR Richebé, MD, PhD

Role: primary

philippe.richebe@umontreal.ca

5147436558

Nadia NG Godin, RN

Role: backup

ngodin.hmr@ssss.gouv.qc.ca

5142523400 ext. 3193

Other Identifiers

2022-2892

Identifier Type: -

Identifier Source: org_study_id