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

NCT06667024 | Completed

• 1 other identifier: 36264MS288/8/23
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dexmedetomidine; Intrathecal; Adjuvant; Hyperbaric Bupivacaine; Analgesia; Arthroscopic Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to first rescue analgesia request

  24 hours postoperatively

• Degree of pain

  24 hours postoperatively

• Duration of motor block

  Intraoperatively

• Patient satisfaction

  24 hours postoperatively

• Incidence of side effects

  24 hours postoperatively

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Drug: Hyperbaric bupivacaine

Dexmedetomidine (study) group

EXPERIMENTAL

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

Drug: Dexmedetomidine and Hyperbaric bupivacaine

Interventions

Hyperbaric bupivacaine DRUG

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

Control group

Dexmedetomidine and Hyperbaric bupivacaine DRUG

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

Dexmedetomidine (study) group

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 31, 2024
• Study Start: September 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)