Clinical trial NCT06406647: Rectroclavicular Block in Orthopedic Surgey
Official title: Adding Ketamine as Adjuvant in Retroclavicular Block in Upper Limb Orthopedic Surgey
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain Management
Lead sponsor: New Valley University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The ultrasound-guided retroclavicular approach to the infraclavicular region (RAPTIR) brachial plexus block has gained popularity as a relatively easy-to-perform nerve block that provides reliable and dense anesthesia to the upper extremity with a single injection. The block has been well described in the anesthesia community since it was first introduced by Hebbard and Royse in 2007 . In 2017, Luftig first described the block's use in the ED setting for a variety of indications . This nerve block has classically been described to provide extensive anesthesia for procedures distal to the shoulder, such as elbow dislocations, distal radius fractures, and surgical procedures.

Detailed description: Ultrasound-guided regional anesthesia of the infraclavicular brachial plexus offers dense anesthesia of the distal upper extremity. The Retro clavicular Approach to The Infraclavicular Region (RAPTIR) is an ultrasound-guided brachial plexus block that has only recently been described in both anesthesia and emergency literature.

Ketamine is a dissociative anesthetic used medically for induction and maintenance of anesthesia. It is also used as a treatment for depression, a pain management tool, and as a recreational drug . Ketamine is a novel compound that was derived from phencyclidine in 1962 in pursuit of a safer anesthetic with fewer hallucinogenic effects .

At anesthetic doses, ketamine induces a state of dissociative anesthesia, a trance-like state providing pain relief, sedation, and amnesia . The distinguishing features of ketamine as anesthesia are preserved breathing and airway reflexes, stimulated heart function with increased blood pressure, and moderate bronchodilation At lower, sub-anesthetic doses, ketamine is a promising agent for pain and treatment-resistant depression. As with many antidepressants, the results of a single administration of ketamine wane with time. The long-term effects of repeated use are largely unknown, and are an area of active investigation.

Liver and urinary toxicity have been reported among regular users of high doses of ketamine for recreational purposes. Ketamine is an NMDA receptor pore blocker, accounting for most of its actions, but not the antidepressant effect, the mechanism of which is a matter of research and debate.

Ketamine was first synthesized in 1962 and approved for use in the United States in 1970. It has been regularly used in veterinary medicine and was extensively used for surgical anesthesia in the Vietnam War. Along with other psychotropic drugs, it is on the World Health Organization's List of Essential Medicines. It is available as a generic medication. When used as a recreational drug, it is found both in powder and liquid form, and is often referred to as "Special K" for its hallucinogenic and dissociative effects.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing upper limb orthopedic surgery,

Exclusion Criteria:

* - Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis).
* Altered conscious level.
* Pregnancy.
* Body mass index (BMI \> 35).
* Patients who have difficulty understanding the study protocol.
* Patients who have any known contraindication to study medications.
* Patient refusal.

Primary outcomes:
measure: numerical rating pain scale .
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Asyūţ
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: New Valley University
name: ahmed ismail, lecture
role: PRINCIPAL_INVESTIGATOR
References: