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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06667024
Enrollment
64
Registered
2024-10-31
Start date
2023-09-01
Completion date
2024-04-30
Last updated
2024-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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.

Interventions

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

DRUGDexmedetomidine and Hyperbaric bupivacaine

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total morphine consumption24 hours postoperativelyThe 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

MeasureTime frameDescription
Time to first rescue analgesia request24 hours postoperativelyTime to the first rescue analgesia (time from end of surgery to first dose of morphine administrated) was recorded
Degree of pain24 hours postoperativelyDegree 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.
Duration of motor blockIntraoperativelyDuration 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.
Patient satisfaction24 hours postoperativelyPatients' 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
Incidence of side effects24 hours postoperativelyIncidence of side effects such as Hypotension, Bradycardia, Shivering, nausea, and vomiting) were recorded.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026