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Multimodal Analgesia Methods in Patients Undergoing IPACK Block in Knee Arthroplasty

NCT ID: NCT04213287

Last Updated: 2019-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-23

Study Completion Date

2020-03-15

Brief Summary

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A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)/ Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) - in patients undergoing total knee arthroplasty. dexketoprofen and paracetamol will be added to both groups and multimodal analgesia will be applied. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).

Detailed Description

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Postoperative pain after total knee arthroplasty is serious and difficult to management. Multimodal analgesia recommended for the pain management. For these reasons, we planned a study involving two multimodal analgesia regimens. Patients who will undergo total knee arthroplasty will receive preemptive oral analgesic (dexketofrofen) 1 hour before the operation. Surgery will be initiated after spinal anesthesia is applied to the patients. Two pain control methods - the combination of Adductor Canal Block (ACB)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)/ IPACK- will be applied at the end of the surgery. dexketoprofenand paracetamol will be added to both groups and multimodal analgesia will be applied. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).

Conditions

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IPACK Block Multimodal Analgesia Postoperative NRS Scores

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Power analysis will be done after a pilot study. Number of patient may vary.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peri-Articular Injections and IPACK

Spinal anesthetic with 2,5 ml 0,5% heavy bupivacaine

At the end of surgery;

PAI: 30 ml 0,025% bupivacaine and

IPACK: 20 ml 0,025% bupivacaine

Group Type EXPERIMENTAL

Dexketoprofen Trometamol

Intervention Type DRUG

Drug: Dexketoprofen Trometamol oral tablet

spinal anesthesia

Intervention Type OTHER

Drug: heavy bupivacaine 2,5 ml 0,5%

IPACK

Intervention Type OTHER

Drug: bupivacaine 20 ml 0,025%

PAI

Intervention Type OTHER

Drug: bupivacaine 30 ml 0,025%

Adductor Canal Block, and IPACK

Spinal anesthetic with 2,5 ml 0,5% heavy bupivacaine

At the end of surgery;

ADD: 20 ml 0,025% bupivacaine and

IPACK: 20 ml 0,025% bupivacaine

Group Type ACTIVE_COMPARATOR

Dexketoprofen Trometamol

Intervention Type DRUG

Drug: Dexketoprofen Trometamol oral tablet

spinal anesthesia

Intervention Type OTHER

Drug: heavy bupivacaine 2,5 ml 0,5%

IPACK

Intervention Type OTHER

Drug: bupivacaine 20 ml 0,025%

Adductor canal block

Intervention Type OTHER

Drug: bupivacaine 20 ml 0,025%

Interventions

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Dexketoprofen Trometamol

Drug: Dexketoprofen Trometamol oral tablet

Intervention Type DRUG

spinal anesthesia

Drug: heavy bupivacaine 2,5 ml 0,5%

Intervention Type OTHER

IPACK

Drug: bupivacaine 20 ml 0,025%

Intervention Type OTHER

PAI

Drug: bupivacaine 30 ml 0,025%

Intervention Type OTHER

Adductor canal block

Drug: bupivacaine 20 ml 0,025%

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty with a participating surgeon
* Age 18 to 80 years
* Planned use of regional anesthesia
* Ability to follow study protocol
* Patients of participating surgeons

Exclusion Criteria

* Hepatic or renal insufficiency
* Younger than 18 years old and older than 80
* Patients undergoing general anesthesia
* Allergy or intolerance to one of the study medications
* BMI \> 40
* Diabetes
* ASA of IV
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of \>5mg/day for one month)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara Diskapi Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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ilkay baran akkuş

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ilkay MD Baran Akkuş, MD

Role: PRINCIPAL_INVESTIGATOR

Diskapi Yildirim Beyazit Training Education Hospital

Locations

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Diskapi Yildirim Beyazit Training Research Hospital

Ankara, Altındag, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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ilkay MD Baran akkus, MD

Role: CONTACT

Phone: 0905323852642

Email: [email protected]

Facility Contacts

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ilkay baran, md

Role: primary

Other Identifiers

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70/13

Identifier Type: -

Identifier Source: org_study_id