Intra-articular Versus Intravenous Dexmedetomidine in Arthroscopic Knee Surgeries Under Local Anesthesia

NCT02730845 | Completed DMC

• 1 other identifier: R∕ 15.10.40
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will be carried to evaluate the efficacy of intra-articular 0.5 bupivacaine with intra-articular or intravenous alpha-2agonist; Dexmedetomidine; for intraoperative anesthesia and postoperative analgesia after arthroscopic knee surgery. Arthroscopic knee surgery is one of the most common minimally invasive orthopedic procedures in recent practice which is frequently performed as a day surgery procedures. It can be done under general, regional or local anesthesia (LA) with or without sedation. It is associated with varying amount of postoperative pain. Postoperative pain negatively influences patient's early ambulation, rehabilitation and psychology which consecutively prolonged the hospital stay. Intra-articular administration of local anesthetic for knee arthroscopy is a well-documented procedure that offers many advantages over other anesthesia types. Many anesthesiologists are still trying to improve the technique of local anesthetic administration through using many combinations with LA solutions in order to administer safe anesthesia to those patients and to obtain a pain-free knee with good operating conditions. Dexmedetomidine is a highly selective α2 adrenergic agonist. It has analgesic, sedative, anxiolytic, hypnotic, sympatholytic, antihypertensive properties with anesthetic sparing effects. It becomes an attractive alternative to the current opioids because it does not have a respiratory depressant or addictive effect.

Conditions

Knee Arthroscopy

Keywords

Elective; local anesthesia; knee arthroscopy; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Pain scores

  Pain will be assessed using 10 cm visual analogue scale (VAS)

  for 24 hours starting immediately before performing the procedure

Secondary Outcomes (10)

• Heart rate

  starting immediately before performing the procedure

• Blood pressure

  starting immediately before performing the procedure

• Oxygen saturation

  starting immediately before performing the procedure

• Respiratory rate

  starting immediately before performing the procedure

• Level of sedation

  For 24 hours after performing the injection

Study Arms (2)

Intra-articular dexmedetomidine

ACTIVE COMPARATOR

Patients will be subjected for elective knee arthroscopy under local anesthesia (Intra-articular dexmedetomidine + Intra-articular bupivacaine).

Drug: Intra-articular dexmedetomidine

Intravenous dexmedetomidine

PLACEBO COMPARATOR

patients will be subjected for elective knee arthroscopy under local anesthesia (i.v. dexmedetomidine + Intra-articular bupivacaine).

Drug: Intravenous dexmedetomidine

Interventions

Intra-articular dexmedetomidine DRUG

Patients will receive an intra-articular mixture of 19 ml bupivacaine 0.5% with epinephrine 1:200.000 added to 1ml (1 µg/kg) of dexmedetomidine (total volume 20 ml), and i.v. saline 20 ml infused over 10 min starting with local anesthesia

Intra-articular dexmedetomidine

Intravenous dexmedetomidine DRUG

Patients will be injected intra-articularly with mixture of 19 ml 0.5% bupivacaine with epinephrine 1:200.000 and 1 ml of isotonic saline (total volume 20 ml), in addition to i.v. 20 ml saline containing 1 µg/kg dexmedetomidine over 10 min infusion starting with local anesthesia.

Intravenous dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical status I or II
• Patients scheduled for elective unilateral knee arthroscopy

You may not qualify if:

• Refusal of local anesthesia
• History of cardiovascular disease
• History of cerebrovascular disease
• History of respiratory diseases
• History of impaired renal functions
• History of impaired hepatic functions
• Pregnancy
• Allergy to the study drugs
• Uncontrolled diabetes
• Coagulopathies
• Hypertension treated with α methyldopa, clonidine or β adrenergic blockers
• Patients receiving chronic pain treatment
• Patients receiving psychoactive drugs
• Patients receiving anticoagulant drugs
• Prior ipsilateral knee surgery

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tarek H Ramadan, MD

  Lecturer of Anesthesia and Surgical Intensive Care

  PRINCIPAL INVESTIGATOR

• Reem A AbdelRaouf, MD

  Lecturer of Anesthesia and Surgical Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: April 7, 2016
• Study Start: December 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: May 30, 2016
• Last Updated: September 22, 2020

Record last verified: 2020-09

Locations

EG (1)