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

Study Overview

• Status: Completed
• Conditions: Analgesia; Dexmedetomidine; Adjuvant; Intrathecal; Arthroscopic Anterior Cruciate Ligament Reconstruction; Hyperbaric Bupivacaine
• Intervention / Treatment: Drug: Hyperbaric bupivacaine; Drug: Dexmedetomidine and Hyperbaric bupivacaine

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption	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.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first rescue analgesia request	Time to the first rescue analgesia (time from end of surgery to first dose of morphine administrated) was recorded	24 hours postoperatively
Degree of pain	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.	24 hours postoperatively
Duration of motor block	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.	Intraoperatively
Patient satisfaction	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	24 hours postoperatively
Incidence of side effects	Incidence of side effects such as Hypotension, Bradycardia, Shivering, nausea, and vomiting) were recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Bupivacaine; Dexmedetomidine
• Other Study ID Numbers: 36264MS288/8/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No