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

NCT05439564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2023-11-24

No results posted yet for this study

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

Interventions

DRUG

Dexmedetomidine

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

Morphine

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

DRUG

Dexmedetomidine

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

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2022-12-30
Completion
2023-01-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05439564 on ClinicalTrials.gov