Regional Anesthesia with Clonidine for Surgery

Overseen By Julie Rice-Weimer

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Nationwide Children's Hospital

Disqualifiers: Systemic infection, Spine abnormalities, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of anesthesia work during surgery for young children. Specifically, it examines the effects of adding clonidine, a medication often used with anesthesia, on spinal and caudal (lower back) nerve blocks. Several groups receive different combinations of anesthesia to determine the most effective approach. Children aged 5 and under undergoing surgeries such as circumcision, hernia repair, or dental procedures may be suitable participants. As an unphased trial, this study provides a unique opportunity to enhance understanding and improve anesthesia techniques for young children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that clonidine is safe to use with anesthesia types that numb specific areas, such as spinal or caudal blocks. Studies have found that it extends pain relief after surgery without causing major side effects. For instance, adding clonidine can increase pain relief by about four hours in children post-surgery.

Another study indicated that clonidine is safe for use in spinal anesthesia for infants undergoing minor surgeries. The FDA has already approved its use in children in this manner, supporting its safety. Overall, clonidine appears well-tolerated when used with regional anesthesia in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of adding clonidine to regional anesthesia techniques used during surgeries. Unlike standard practices that often rely solely on general anesthesia, this trial investigates how clonidine, an FDA-approved medication, might enhance pain management and reduce the need for stronger anesthetics. Clonidine is unique because it can be used as an adjunct to spinal and caudal anesthesia, potentially improving patient outcomes by providing more effective pain relief and possibly shortening recovery times. By comparing various combinations of anesthesia with and without clonidine, researchers hope to find more effective and safer methods to manage surgical pain.

What evidence suggests that this trial's treatments could be effective?

Research shows that adding clonidine to regional anesthesia can extend pain relief for children after surgery. In this trial, some participants will receive general anesthesia with caudal anesthesia, with or without clonidine, to evaluate its effectiveness. Studies have found that clonidine, when used with caudal anesthesia (administered near the lower spine), prolongs pain relief compared to local anesthetics alone. Other participants will receive spinal anesthesia with or without clonidine, as clonidine also enhances spinal anesthesia, providing effective results with fewer side effects. It is commonly used and approved to enhance these types of anesthesia in children. Overall, clonidine improves the effectiveness and duration of anesthesia without increasing complications. ^{1 6 7 8 9}

Who Is on the Research Team?

Grant Heydinger, MD

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

This trial is for pediatric patients needing surgery where spinal or caudal blockade anesthesia will be used. It's designed to test a non-invasive EMG monitoring device during the operation. Patients with conditions that might interfere with EMG readings or those who can't receive the study drugs may not qualify.

Inclusion Criteria

I am 5 years old or younger and need a circumcision or its revision.

I am 5 years old or younger and need surgery for dental, urological, or ENT issues.

My child is 5 or younger and needs specific surgery.

Exclusion Criteria

Medication allergy

I have a body-wide infection.

My parents have refused participation in the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Intraoperative EMG monitoring to assess neuraxial anesthesia and the effect of adjunctive intrathecal clonidine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Clonidine
• Regional Anesthesia EMG Study

Trial Overview The study tests how well an EMG device can track anesthesia effects in real-time during surgery. It also looks at whether adding clonidine to the anesthesia affects these readings, and it examines sevoflurane's impact on muscle tone through EMG data.

How Is the Trial Designed?

Group I: General Anesthesia with Penile Block Active Control 1 Intervention

Penile block: prior to the start of surgery 0.5mg/kg of 0.25% bupivacaine w/o epinephrine will be administered GA : Inhalation induction with sevoflurane followed by peripheral IV access, and placement of an endotracheal tube or laryngeal mask airway. No intravenous neuromuscular blockade will be given. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.

Group II: General Anesthesia only Active Control 2 Interventions

GA alone: Inhalation induction with sevoflurane followed by peripheral IV access, and placement of an endotracheal tube or laryngeal mask airway. No intravenous neuromuscular blockade will be given. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.

Group III: General Anesthesia with Caudal Anesthesia with Clonidine Active Control 3 Interventions

Caudal block: single-shot caudal injection following induction of GA with 1mL/kg of 0.25% bupivacaine with 1:200,000 epinephrine, with or without clonidine 1mcg/kg Clonidine is an FDA approved medication that is commonly administered as an adjunct to SA and CA in this population.

Group IV: Spinal Anesthesia without Clonidine Active Control 1 Intervention

Spinal block: 0.5% isobaric bupivacaine with 1:200,000 epinephrine (0.2mL/kg up to 1mL), with or without 1mcg/kg clonidine

Group V: General Anesthesia with Caudal Anesthesia without Clonidine Active Control 2 Interventions

Caudal block: single-shot caudal injection following induction of GA with 1mL/kg of 0.25% bupivacaine with 1:200,000 epinephrine, with or without clonidine 1mcg/kg

Group VI: Spinal Anesthesia with Clonidine Active Control 2 Interventions

Spinal block: 0.5% isobaric bupivacaine with 1:200,000 epinephrine (0.2mL/kg up to 1mL), with or without 1mcg/kg clonidine Clonidine is an FDA approved medication that is commonly administered as an adjunct to SA and CA in this population.

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

Published Research Related to This Trial

In a study of 50 patients undergoing upper limb surgery, adding 100 μg of clonidine to bupivacaine significantly accelerated the onset of sensory and motor blockade compared to bupivacaine alone.

The combination of clonidine and bupivacaine not only prolonged the duration of sensory and motor block but also provided effective postoperative analgesia with mild sedation, without adversely affecting hemodynamic parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Clonidine as an Additive on the Duration of Action of Brachial Plexus Block Performed Under Ultrasound and Nerve Locator Guidance: A Prospective Randomized Study. Hrishi, AP., Rao, G., Lionel, KR.[2022]

In a study of 60 patients undergoing major vascular surgery, adding clonidine to morphine for epidural analgesia resulted in significantly lower pain scores at rest and during movement at 2, 6, and 24 hours after infusion, compared to other combinations.

Clonidine combined with morphine also provided a longer duration of analgesic effect after the epidural infusion ended, although it was associated with longer mechanical ventilation times for patients, highlighting the need for careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does epidural clonidine improve postoperative analgesia in major vascular surgery? Vuković, J., Ramakrishnan, P., Milan, Z.[2022]

In a study involving 30 patients undergoing upper extremity orthopedic procedures, adding 1 microg/kg clonidine to 20 ml of 0.75% ropivacaine for axillary brachial plexus anesthesia resulted in a significant delay of about 3 hours in the first request for postoperative analgesics compared to ropivacaine alone.

The addition of clonidine did not adversely affect sedation levels or cardiovascular stability, indicating that it can enhance pain management without compromising patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving postoperative analgesia after axillary brachial plexus anesthesia with 0.75% ropivacaine. A double-blind evaluation of adding clonidine. Casati, A., Magistris, L., Beccaria, P., et al.[2022]

In a study of 124 children undergoing cleft lip and palate surgery, adding clonidine to bupivacaine for nerve blocks significantly reduced the incidence of emergence agitation from 30.2% to 15.2%.

Clonidine also decreased the need for intraoperative Fentanyl, with only 10.6% of patients in the clonidine group requiring it compared to 26.4% in the control group, all without causing hemodynamic or sedative side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clonidine as an Adjuvant to Bupivacaine for Suprazygomatic Maxillary Nerve Blocks in Cleft lip and Palate Repair: A Randomized, Prospective, Double-Blind Study. Barbero, GE., de Miguel, M., Sierra, P., et al.[2021]

Adding 150 micrograms of clonidine to mepivacaine significantly prolongs the duration of anesthesia and analgesia after an axillary brachial plexus block, with increases of 37% and 103% respectively compared to mepivacaine alone.

The study involved 30 patients and found no adverse effects, indicating that the addition of clonidine is safe and suggests a local mechanism of action rather than a systemic one.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding clonidine to mepivacaine prolongs the duration of anesthesia and analgesia after axillary brachial plexus block. Singelyn, FJ., Dangoisse, M., Bartholomée, S., et al.[2013]

Clonidine, when used as a co-analgesic during scoliosis surgery, significantly reduces the amplitude of transcranially evoked motor potentials (TcEMEPs) within five minutes of administration, compromising neuromonitoring of spinal motor pathways in children.

This study highlights the need for caution when using clonidine and other α-2 adrenergic agonists in surgical settings where monitoring of motor pathways is critical, as it can severely interfere with the assessment of spinal cord function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clonidine administration during intraoperative monitoring for pediatric scoliosis surgery: Effects on central and peripheral motor responses. Calderón, P., Deltenre, P., Stany, I., et al.[2018]

In a study involving 42 children aged 3-12 undergoing upper limb surgeries, a dose of 1 μg.kg-1 of clonidine significantly prolonged the duration of analgesia and motor block compared to a lower dose of 0.5 μg.kg-1, with mean analgesia lasting 11.35 hours versus 9.94 hours.

While the higher dose of clonidine was effective, it also resulted in increased sedation, suggesting that a lower dose may be preferable to minimize side effects while still providing effective pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Two Different Doses of Clonidine as an Adjuvant to Bupivacaine in Ultrasound-Guided Supraclavicular Brachial Plexus Block for Pediatric Upper Limb Surgeries - A Randomized Trial. Sharma, R., Kamal, G., Agarwal, S., et al.[2022]

In a double-blind randomized trial involving 100 patients, adding 50 mcg of intrathecal clonidine to bupivacaine significantly increased the duration of both sensory block (295.2 minutes) and motor block (280.8 minutes) compared to bupivacaine alone.

The combination of clonidine and bupivacaine also provided longer postoperative analgesia (551.1 minutes) than bupivacaine with placebo (254.8 minutes), although the study group experienced less hemodynamic stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Clonidine as adjuvant to intrathecal bupivacaine in patients undergoing lower abdominal surgery: A randomized control study. Singh, RB., Chopra, N., Choubey, S., et al.[2022]

A meta-analysis of 14 studies involving 1,120 patients found no significant differences in adverse events between dexmedetomidine and clonidine when used as adjuvants in local anesthesia.

Common adverse events such as bradycardia, hypotension, nausea, vomiting, dizziness, headache, shivering, and dry mouth occurred at similar rates for both medications, indicating comparable safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Study of the Adverse Events Associated With Adjuvant Use of Dexmedetomidine and Clonidine in Local Anesthesia. Jiang, J., Shen, H., Zhang, J., et al.[2021]

Oral clonidine premedication at a dose of 2.5 mcg/kg provided effective sedation and anxiolysis without prolonging the duration of sensory and motor block after subarachnoid anesthesia, making it a safe option for patients.

The study found that clonidine did not cause significant hypotension or adverse hemodynamic effects, while the higher dose of 5 mcg/kg was associated with some side effects like bradycardia and bradypnea, suggesting that the lower dose is preferable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral clonidine premedication does not prolong analgesia after herniorrhaphy under subarachnoid anesthesia. Ezri, T., Szmuk, P., Shklar, B., et al.[2019]

Oral clonidine premedication (2.5 and 5 micrograms/kg) significantly reduces heart rate and mean arterial pressure responses during ketamine anesthesia, indicating its efficacy in managing hemodynamic changes in patients undergoing surgery.

The higher dose of clonidine (5 micrograms/kg) not only lessens cardiovascular responses but also decreases the incidence of nightmares and excessive salivation associated with ketamine, suggesting improved overall patient comfort during and after anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of oral clonidine premedication on side effects of intravenous ketamine anesthesia: a randomized, double-blind, placebo-controlled study. Handa, F., Tanaka, M., Nishikawa, T., et al.[2019]

Citations

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Efficacy and safety of clonidine as additive for caudal regional ... The review concluded that, compared to caudal local anaesthetics alone, caudally administered clonidine in addition to local anaesthetics provided extended ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22023418/

Efficacy and Safety of Clonidine as Additive for Caudal ... Conclusions: There is considerable evidence that caudally administered clonidine in addition to local anesthetics provides extended duration of analgesia with a ...

3. cureus.com cureus.com/articles/300592-effect-of-clonidine-on-duration-of-high-volume-low-concentration-caudal-epidurals

Effect of Clonidine on Duration of High-Volume, Low ... Our results suggest that adding clonidine to an HVLC solution of ropivacaine does not extend the time to the first postoperative administration ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/am-pdf/10.1111/pan.15091

Safety of Intrathecal Clonidine in Infants & Children Introduction: Preliminary clinical studies have demonstrated that clonidine is an effective adjuvant to spinal anesthesia in neonates and ...

5. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.723191/full

Clonidine as an Additive to Local Anesthetics in Caudal ... Conclusion: Clonidine has the same efficacy as the other adjuvants for caudal epidural block for pediatric surgery but fewer complications.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11975205/

Safety of Intrathecal Clonidine as an Adjuvant to Spinal ... Our data indicate that clonidine is a safe adjuvant in spinal anesthesia for infants presenting for outpatient ambulatory surgical procedures.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/j.1460-9592.2011.03715.x

Efficacy and safety of clonidine as additive for caudal ... There was a longer duration of postoperative analgesia in children receiving clonidine in addition to local anesthetic (MD: 3.98 h; 95% CI: 2.84 ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1098733908000047

Clonidine as an Adjuvant to Intrathecal Local Anesthetics ... Clonidine is added to intrathecal local anesthetics to improve intraoperative analgesia and to increase the duration of sensory and motor block.

9. healthcare-bulletin.co.uk healthcare-bulletin.co.uk/article/a-study-of-the-efficacy-of-clonidine-as-an-adjuvant-to-bupivacaine-heavy-0-5-in-spinal-anesthesia-for-patients-undergoing-infra-umbilical-surgeries--3213/

A Study of The Efficacy of Clonidine as An Adjuvant to ... This study was done to determine efficacy of adding intrathecal clonidine to bupivacaine hyperbaric(0.5%) in spinal anaesthesia in patients undergoing infra- ...