Intrathecal Morphine Versus Morphine-dexmedetomidine Combination for Postoperative Pain Control After Total Knee Replacement
Primary Purpose
Intrathecal Morphine, Intrathecal Morphine-dexmedetomidine Combination, Postoperative Pain Control
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
Morphine
Dexmedetomidine
Sponsored by
About this trial
This is an interventional prevention trial for Intrathecal Morphine
Eligibility Criteria
Inclusion Criteria:
- 105 patients, aged >50 years, with ASA Physical Status Class II and III, scheduled for TKR under spinal anesthesia
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Group morphine
Group morphine-Dex
Group Dex
Arm Description
Group morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine.
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.
Group Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine.
Outcomes
Primary Outcome Measures
The onset of pain
The onset of pain is defined as VAS ≥ 4 within 24 hours
Secondary Outcome Measures
Postoperative pain severity
VAS ≥ 4 within 24 hours
The amount of additional analgesic required
Patients with VAS ≥ 4 will be received 3 mg morphine IV. Patients who complained of pain (VAS < 3) and needed analgesics will be treated with intravenous infusion every six to eight hours with Diclofenac Na(75mg).
Postoperative complications
the incidence of PONV, respiratory depression, and itching.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05439564
Brief Title
Intrathecal Morphine Versus Morphine-dexmedetomidine Combination for Postoperative Pain Control After Total Knee Replacement
Official Title
Intrathecal Morphine Versus Morphine-dexmedetomidine Combination for Postoperative Pain Control After Total Knee Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
105 patients, aged >50 years, with ASA Physical Status Class II and III, scheduled for TKR under spinal anesthesia will be included in this study.
105 Patients will be randomly allocated into three equal groups (35 patients each):
Group morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine.
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.
Group Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine
Measurements:
Demographic data as age, BMI, ASA status, duration of surgery
During surgery, systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) will be recorded at the 1st, 5th, 15th, 30th, and 60th minutes.
Postoperative pain severity assessed by the visual analog score for pain at rest (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively at 30 min and 2, 4, 6, 12, and 24 h postoperative. Accordingly, the patient is requested to verbally express his degree of pain using this scale. Patients with the visual analog score≥ 4 will be received 3 mg morphine IV and will be recorded. Patients who complained of pain (the visual analog score< 3) and needed analgesics will be treated intravenous infusion every six to eight hours with Diclofenac Na(75mg).
The total dose of morphine used postoperatively will be observed and recorded for the 1st, 2nd, 6th, 12th, and 24th postoperative hours.
The period from the moment the intrathecal injection will be made postoperatively until the first analgesic became necessary will be recorded
Any recorded postoperative complication as sedation, nausea and vomiting, respiratory depression.
The patient's level of sedation will be assessed at the same time points using Ramsay Sedation Scale (score 3-4 mean adequate sedation). (17)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrathecal Morphine, Intrathecal Morphine-dexmedetomidine Combination, Postoperative Pain Control, Total Knee Replacement
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group morphine
Arm Type
Placebo Comparator
Arm Description
Group morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine.
Arm Title
Group morphine-Dex
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group Dex
Arm Type
Active Comparator
Arm Description
Group Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
morphine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Group morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Group Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine.
Primary Outcome Measure Information:
Title
The onset of pain
Description
The onset of pain is defined as VAS ≥ 4 within 24 hours
Time Frame
upto 24 hours postoperative
Secondary Outcome Measure Information:
Title
Postoperative pain severity
Description
VAS ≥ 4 within 24 hours
Time Frame
upto 24 hours postoperative
Title
The amount of additional analgesic required
Description
Patients with VAS ≥ 4 will be received 3 mg morphine IV. Patients who complained of pain (VAS < 3) and needed analgesics will be treated with intravenous infusion every six to eight hours with Diclofenac Na(75mg).
Time Frame
upto 24 hours postoperative
Title
Postoperative complications
Description
the incidence of PONV, respiratory depression, and itching.
Time Frame
upto 24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
105 patients, aged >50 years, with ASA Physical Status Class II and III, scheduled for TKR under spinal anesthesia
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
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Intrathecal Morphine Versus Morphine-dexmedetomidine Combination for Postoperative Pain Control After Total Knee Replacement
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