Intrathecal Morphine Versus Morphine-dexmedetomidine Combination for Postoperative Pain Control After Total Knee Replacement

NCT05439564 | Completed

• 1 other identifier: Intrathecal morphine-precedex
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee replacement is one of the most painful orthopedic surgical procedures. Patients who undergo total knee replacement are usually older and have limited cardiac and pulmonary reserves. The increased sensitivity of elderly patients to drugs makes it necessary to choose postoperative analgesia agents and methods that have minimal side effects. Intrathecal injection of morphine to provide postoperative analgesia during the initial 24-h after the operation is a widely used technique, however, opioid therapy is limited because of the side effects (hypotension, pruritus, nausea, urinary retention, respiratory depression) and intolerance. Alpha-2 adrenergic agonists (clonidine and dexmedetomidine) have pharmacologic characteristics (sedation, hypnosis, anxiolysis, sympatholytic, and analgesia) that make them suitable as adjuvants to multimodal analgesia. Their anti-nociceptive effect is attributed to the stimulation of a2- adrenoceptors located in the central nervous system. The rationale for combining analgesics that produce similar therapeutic effects or synergistic interactions is to accentuate the analgesic efficacy and decrease the side effects by permitting dose reduction of each agent. Human studies on the antinociceptive effects of co-administrated intrathecal morphine (ITM) and dexmedetomidine in postoperative pain are still few. On the other hand, Abdel-Ghaffar et al., results do not support improved analgesia with the combination of intrathecal morphine and dexmedetomidine, despite the absence of significant adverse effects. We hypothesized that the addition of dexmedetomidine to ITM would improve the quality of perioperative pain control and decrease the side effects of postoperative systemic opioid use.

Conditions

Intrathecal Morphine; Intrathecal Morphine-dexmedetomidine Combination; Postoperative Pain Control; Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• The onset of pain

  The onset of pain is defined as VAS ≥ 4 within 24 hours

  upto 24 hours postoperative

Secondary Outcomes (3)

• Postoperative pain severity

  upto 24 hours postoperative

• The amount of additional analgesic required

  upto 24 hours postoperative

• Postoperative complications

  upto 24 hours postoperative

Study Arms (3)

Group morphine

PLACEBO COMPARATOR

Group morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine.

Drug: Morphine

Group morphine-Dex

ACTIVE COMPARATOR

Group morphine-Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine plus 5 mcg of dexmedetomidine.

Drug: Dexmedetomidine; Drug: Morphine

Group Dex

ACTIVE COMPARATOR

Group Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Group morphine-Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine plus 5 mcg of dexmedetomidine.

Also known as: morphine

Group morphine-Dex

Morphine DRUG

Group morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine.

Group morphine; Group morphine-Dex

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients, aged \>50 years, with ASA Physical Status Class II and III, scheduled for TKR under spinal anesthesia

You may not qualify if:

• Patients who had bleeding disorders
• Patients who had heart, liver, or renal failure
• Patients who had systemic infections or infections of their injection sites
• Patients with a known allergy to study
• Patients who had 2nd or 3rd-degree heart block
• Those with low back pain or other back problems
• History of drug or alcohol abuse
• Body mass index (BMI) \> 30 kg\\m2
• Patients with psychiatric illnesses that would interfere with perception and assessment of pain.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine, Tantan University Hospital

Tanta, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Morphine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of anesthesiology, intensive care, and pain medicine

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: June 30, 2022
• Study Start: July 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 30, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)