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

NCT ID: NCT06667024

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

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

Group Type: ACTIVE_COMPARATOR

Hyperbaric bupivacaine

Intervention Type: DRUG

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

Dexmedetomidine (study) group

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

Group Type: EXPERIMENTAL

Dexmedetomidine and Hyperbaric bupivacaine

Intervention Type: DRUG

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

Interventions

Hyperbaric bupivacaine

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

Intervention Type: DRUG

Dexmedetomidine and Hyperbaric bupivacaine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Abdallah Elsayed Elkasrawy

Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Countries

Egypt

Other Identifiers

36264MS288/8/23

Identifier Type: -

Identifier Source: org_study_id