NCT05963139

Comparison of Local Anesthetic Dose in Ipack Block Performed in Knee Arthroplasty Operations

Completed NA Last updated 13 February 2024

What this trial tests

NA trial testing Bupivacaine in Analgesia in 112 participants. Completed in 10 February 2024.

Timeline

1 August 2023

Primary endpoint
1 February 2024

10 February 2024

Quick facts

Lead sponsor	Istanbul University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	112
Start date	1 August 2023
Primary completion	1 February 2024
Estimated completion	10 February 2024
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Bupivacaine (BUPIVACAINE) — full drug profile →
• Morphine Sulfate — full drug profile →

Conditions studied

• Analgesia — all drugs for Analgesia →
• Pain, Postoperative — all drugs for Pain, Postoperative →
• Anesthesia — all drugs for Anesthesia →

Sponsor

Istanbul University

Who can join

Adults 18 to 80, any sex, with Analgesia or Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators research was designed as a single-center, prospective, randomized study. The patients undergoing knee artrhroplasty surgery in Istanbul University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will not be included in the study.

Patients will be given US guided IPACK and adductor blocks using a 22 gauge 10 mm block needle after compliance with the rules of asepsia and antisepsis in the supine position according to the group of patients in which they were included.

IPACK and adductor block will be done for postoperative analgesia. After then, a single dose of spinal anesthesia will be applied as a regional anesthesia method, in a sitting position, using the appropriate spinal needle, as is routinely applied in the investigators clinic. After the block is completed, the pinprick test will be done and the operation will be started after the successful completion of the block is confirmed. Oxygen will be given to the patients with a face mask at 4 lt / min throughout the operation. ECG, saturation, invasive / noninvasive blood pressure monitoring of the patients will be done.

In the investigators clinic, the use of IPACK block, adductor block and PCA (patient controlled analgesia) device with intravenous morphine for postoperative analgesia is routinely performed. In this study, four randomized groups will be formed together with the control group.

IPACK block will be applied to the 1st group with 10 ml of 0.25% bupivacaine, to the 2nd group with 15 ml of 0.25% bupivacaine, and to the 3rd group with 20 ml of 0.25% bupivacaine.Adductor block will be applied to all the groups with 15 ml %0,25 bupivacaine and PCA (patient controlled analgesia) device with intravenous morphine for postoperative analgesia is performed.

Pain score and total morphine consumption will be determined by numeric rating scale (NRS) at the postoperative 1, 4, 8, 12, 24 and 48th hours by providing the use of a PCA device with intravenous morphine applied in routine practice to all four groups. As in routine practice, when NRS \> 4 after each interrogation, morphine 2 mg iv will be administered as additional analgesia and the maximum will be increased to 10 mg. Pain management will continue when NRS \< 4.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.