Low Dose Ketamine Infusion for Postoperative Analgesia After Total Knee Arthroplasty

NCT04085588 | Completed

• 1 other identifier: 15.04.2019-07
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Keywords

Pain; analgesia; Postoperative; Ketamine; Morphine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Early and late period pain

  3 months from the operation

• side effects,

  3 months

• length of hospital stay

  3 months

• patient satisfaction

  3 months

Study Arms (3)

Group 1

All patients were revived spinal anesthesia with 3 mL marcaine 0.5% and after surgery a 2 mg bolus morphine PCA pump was connected to them. Before the skin incision, when sensorial block reached T10 dermatome level 2 μg / kg / min ketamine was started in Group 1. By the end of the operation ketamine infusion was reduced to 1 μg / kg / min.

Group 2

All patients were revived spinal anesthesia with 3 mL marcaine 0.5% and after surgery a 2 mg bolus morphine PCA pump was connected to them. Before the skin incision, when sensorial block reached T10 dermatome level 4 μg / kg / min ketamine was started . By the end of the operation ketamine infusion was reduced to 2 μg / kg /min and continued.

Group 3

All patients were revived spinal anesthesia with 3 mL marcaine 0.5% and after surgery a 2 mg bolus morphine PCA pump was connected to them. Before the skin incision, when sensorial block reached T10 dermatome level 6 μg / kg / min ketamine was started . By the end of the operation ketamine infusion was reduced to 3 μg / kg /min and continued.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Being female or male can make difference in pain sensitivity and analgesic response. To facilitate of interpretation the results, only one gender (females) was included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

unilateral total knee arthroplasty cases

You may qualify if:

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

You may not qualify if:

• Patients younger than 18 years of age
• ASA Ⅳ 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

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Mustafa Kemal University Medical School

Hatay, 31100, Turkey (Türkiye)

Location

Related Publications (5)

• Memtsoudis SG, Poeran J, Zubizarreta N, Cozowicz C, Morwald 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):891-902. doi: 10.1097/ALN.0000000000002132.

  PMID: 29498951 RESULT

• 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.

  PMID: 10467917 RESULT

• 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.DC.

  PMID: 15673878 RESULT

• 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 Pain. 2009 Jul;13(6):613-9. doi: 10.1016/j.ejpain.2008.08.003. Epub 2008 Sep 14.

  PMID: 18793861 RESULT

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

  RESULT

MeSH Terms

Conditions

Pain, Postoperative; Pain; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Selim Turhanoglu, M.D.

  Mustafa Kemal University, Medical School, 31100 Hatay, Turkey

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 11, 2019
• Study Start: April 15, 2019
• Primary Completion: September 2, 2021
• Study Completion: September 2, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

TU (1)