Low Dose Ketamine Infusion for Postoperative Analgesia After Total Knee Arthroplasty

Postoperative Pain Clinical Trial

Official title:

Low Dose Ketamine Infusion for Postoperative Analgesia After Total Knee Arthroplasty: Optimum Dose to Reduce Morphine Consumption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085588
• Other study ID #: 15.04.2019-07
• Status: Completed
• Start date: April 15, 2019
• Est. completion date: September 2, 2021

Study information

• Verified date: September 2021
• Source: Mustafa Kemal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates continous infusion of low-dose ketamine during intraoperative and postoperative periods at three different doses to provide postoperative analgesia in total knee arthroplasty cases. Patients enrolled randomly into one of 2, 4, 6 μg / kg / min perioperative ketamine groups. All groups were given spinal anesthesia and intravenous patient controlled anesthesia. Ketamine was started when sensorial block reached T10 dermatome level before the skin incision. By the end of the operation, in all groups, ketamine infusions were reduced by half doses. Intravenous patient-controlled analgesia device was set to 2 mg bolus morphine with no basal infusion for 48 hours during the postoperative period.

Description:

Multimodal analgesia, which involves the administration of two or more analgesic agents targeting different levels of pain pathways, is used to improve pain control while also to reduce opioid use and related side effects. Pain can be treated at various neurophysiological levels, including peripheral, spinal and cortical targets. One of the agents used in the multimodal analgesia technique is ketamine.

Ketamine acts on the central nervous system (CNS) and has local anesthetic effect. Ketamine is an N-methyl D-Aspartate (NMDA) receptor antagonist, which appears to be the main mechanism of anesthetic and analgesic action at CNS and spinal cord receptors. Other mechanisms of action of ketamine include the interaction with opioid receptors, particularly mu and kappa receptors. Another effect is that it has local anesthetic effect in high doses. Studies have shown that ketamine is an effective agent in the treatment of postoperative pain. Continuous infusion of low-dose ketamine after total knee arthroplasty significantly reduced morphine consumption, and provided early rehabilitation without increasing side effects. However, when these studies are considered, there is no information about the optimal dose of ketamine that reduces opioid consumption at the highest level.

In our study, continuous infusion of low-dose ketamine at different doses was planned to provide postoperative analgesia. Therefore, our first aim in this study was to find out the optimal dose that reduced morphine consumption for postoperative analgesia after TKA with continuous ketamine infusion at different doses. The secondary objectives are to evaluate early and late period pain, side effects, length of hospital stay, patient satisfaction, and recovery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2, 2021
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA I-? female patients scheduled for unilateral total knee arthroplasty

Exclusion Criteria:

• Patients younger than 18 years of age

• ASA ? and above patients

• Having previous knee surgery on the same side

• Patients with allergies to drugs to be used in the study

• Contraindication for spinal anesthesia

• Body mass index 40 kg / m2 and above patients

• Opioid tolerance

• Patients with neurological or psychiatric disorders

• Patients who do not have the ability to use patient controlled analgesia device

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Locations

Country	Name	City	State
Turkey	Mustafa Kemal University Medical School	Hatay

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Adam F, Chauvin M, Du Manoir B, Langlois M, Sessler DI, Fletcher D. Small-dose ketamine infusion improves postoperative analgesia and rehabilitation after total knee arthroplasty. Anesth Analg. 2005 Feb;100(2):475-480. doi: 10.1213/01.ANE.0000142117.82241 — View Citation

Aveline C, Gautier JF, Vautier P, Cognet F, Hetet HL, Attali JY, Leconte V, Leborgne P, Bonnet F. Postoperative analgesia and early rehabilitation after total knee replacement: a comparison of continuous low-dose intravenous ketamine versus nefopam. Eur J — View Citation

Memtsoudis SG, Poeran J, Zubizarreta N, Cozowicz C, Mörwald EE, Mariano ER, Mazumdar M. Association of Multimodal Pain Management Strategies with Perioperative Outcomes and Resource Utilization: A Population-based Study. Anesthesiology. 2018 May;128(5):89 — View Citation

Pai A, Heining M. Ketamine. Continuing Education in Anaesthesia, Critical Care and Pain 2007; Volume 7,Number 2.

Schmid RL, Sandler AN, Katz J. Use and efficacy of low-dose ketamine in the management of acute postoperative pain: a review of current techniques and outcomes. Pain. 1999 Aug;82(2):111-125. doi: 10.1016/S0304-3959(99)00044-5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal dose of Ketamine to reduce morphine consumption	Ketamine infusions 2µg 4µg and 6µg / kg / min will be started preoperatively in group 1, 2 and 3 respectively when sensory block level reaches T10 after spinal anesthesia, and they will be reduced by half by the end of the operation. Ketamine infusion will be continued for 48 hours postoperatively.	48 hours from the operation
Secondary	Early and late period pain	The pain status of the patients at rest and in motion with 100 mm visual pain scale (VAS) (0= no pain and 100 = intolerable pain) will be evaluated and recorded preoperative and postoperative at 2nd, 6th, 12th, 24th and 48th hours.and after 3 months	3 months from the operation
Secondary	side effects,	Nausea, vomiting, itching, respiratory depression, hallucination and diplopia	3 months
Secondary	length of hospital stay	Hospital stay (as day) required for active knee flexion to 90 degrees (measured with goniometer) will be recorded.	3 months
Secondary	patient satisfaction	5 point likert scale	3 months