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

T

Tanta University

Status

Completed

Conditions

Hyperbaric Bupivacaine
Intrathecal
Dexmedetomidine
Adjuvant
Arthroscopic Anterior Cruciate Ligament Reconstruction
Analgesia

Treatments

Drug: Dexmedetomidine and Hyperbaric bupivacaine
Drug: Hyperbaric bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT06667024
36264MS288/8/23

Details and patient eligibility

About

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

Full description

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.

Enrollment

64 patients

Sex

All

Ages

21 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

64 participants in 2 patient groups

Control group
Active Comparator group
Description:
Patients received the standard spinal anesthesia with 0.5% 3 ml according to the patient hyperbaric bupivacaine only.
Treatment:
Drug: Hyperbaric bupivacaine
Dexmedetomidine (study) group
Experimental group
Description:
Patients received dexmedetomidine 4 μg and 0.5% (3-4 ml according to the patient's height) hyperbaric bupivacaine.
Treatment:
Drug: Dexmedetomidine and Hyperbaric bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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