Skip to main content
OpenTrials
Completed

NCT Number: NCT06667024

Dexmedetomidine as an Intrathecal Adjuvant to Hyperbaric Bupivacaine for Postoperative Analgesia in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction Surgeries

This study aimed to evaluate the effect of adding low doses of dexmedetomidine to hyperbaric bupivacaine during spinal anesthesia on post operative analgesia characteristics in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgeries

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dexmedetomidine Adjuvant Agnosia Analgesia Arthroscopic Anterior Cruciate Ligament Reconstruction Hyperbaric Bupivacaine Intrathecal Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

The anterior cruciate ligament (ACL) is injured frequently during sports participation. Arthroscopic evaluation of patients with acute traumatic hemarthrosis of the knee has repeatedly demonstrated a 60% to 70% incidence of ACL injury.

Postoperative pain should be effectively treated because it represents an important component of postoperative recovery. Effective treatment serves to blunt autonomic, somatic, and endocrine reflexes with a resultant potential decrease in perioperative morbidity.

Dexmedetomidine is a highly selective α2-adrenergic agonist that has been used for premedication and as an adjunct to general anesthesia. It reduces opioid and inhalational anesthetics requirements.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged from 21 to 50 years.
  • Both genders.
  • American society of anesthesiologists (ASA) physical status I and II.
  • Patients scheduled for arthroscopic anterior cruciate ligament reconstruction surgeries under spinal anesthesia.

Exclusion criteria

  • Patient refusal.
  • Body Mass Index (BMI) more than 40 kg/m2.
  • Patients who were taking analgesics for chronic pain on opioid therapy or have a history of drug abuse.
  • Uncooperative patient.
  • Patients with coagulation disorders.
  • History of local anesthetics allergy.
  • Infection at the needle puncture site.
  • Patients with significant respiratory, cardiac, renal or hepatic disorders

Treatment and study plan

Hyperbaric bupivacaine

Drug

Patients received the standard spinal anesthesia with 0.5% 3 ml according to the patient hyperbaric bupivacaine only

Dexmedetomidine and Hyperbaric bupivacaine

Drug

Patients received dexmedetomidine 4 μg and 0.5% (3-4 ml according to the patient height) hyperbaric bupivacaine

Primary outcomes

  1. Total morphine consumption

    Time frame: 24 hours postoperatively

    The rescue analgesia was morphine IV bolus of 3 mg with when VAS > 30. Total morphine consumption in the first 24 hours postoperatively was documented.

Secondary outcomes

  1. Time to first rescue analgesia request

    Time frame: 24 hours postoperatively

    Time to the first rescue analgesia (time from end of surgery to first dose of morphine administrated) was recorded

  2. Degree of pain

    Time frame: 24 hours postoperatively

    Degree of pain was assessed using Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 100 represents "the worst pain imaginable"). VAS was assessed at PACU, 1, 2, 4, 8, 12, 18, 24 hours postoperatively.

  3. Duration of motor block

    Time frame: Intraoperatively

    Duration of motor block starting from the time when the Bromage score 3 after spinal anesthesia until the time when the Bromage score was 0 postoperative.

  4. Patient satisfaction

    Time frame: 24 hours postoperatively

    Patients' satisfaction was measured 24 hours postoperative using a five-point Likert scale consisting of:

    1: Very dissatisfied, 2: Dissatisfied, 3: Unsure, 4: Satisfied, 5: Very satisfied

  5. Incidence of side effects

    Time frame: 24 hours postoperatively

    Incidence of side effects such as Hypotension, Bradycardia, Shivering, nausea, and vomiting) were recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.