Adductor Canal Block in Total Knee Arthroplasty

NCT05715437 | Unknown Phase 4

• 1 other identifier: Adductor canal block
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate whether adding ketamine to bupivacaine is superior to bupivacaine alone in terms of providing better pain control for 48 hours postoperatively after TKA.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale (VAS)

  Maximum postoperative pain assessment by the visual analogue scale (VAS) pain scores in the first 48 hours.

  48 hours

Secondary Outcomes (4)

• analgesia

  48 hours

• Analysis include quadriceps strength

  48 hours

• Satisfaction of the patients

  48 hours

• Reporting side effects of drugs given

  48 hours

Study Arms (2)

Bupivacaine plus Normal Saline

EXPERIMENTAL

30 patients will receive bolus shot 20ml of 0.5% of Bupivacaine plus 1ml Normal saline postoperative TKA.

Drug: Bupivacaine plus Normal Saline

Bupivacaine and Ketamine

EXPERIMENTAL

30 patients will receive bolus shot 20ml of 0.5% of Bupivacaine plus 1ml ketamine (50mg) postoperative TKA.

Drug: Bupivacain and ketamine

Interventions

Bupivacaine plus Normal Saline DRUG

Effect of Bupivacain and ketamine and is superior to Bupivacaine and Normal Saline in terms of providing better pain control for 48 hours postoperatively after TKA.

Bupivacaine plus Normal Saline

Bupivacain and ketamine DRUG

Effect of Bupivacain and ketamine and is superior to Bupivacaine and Normal Saline in terms of providing better pain control for 48 hours postoperatively after TKA.

Bupivacaine and Ketamine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is scheduled for elective primary unilateral TKA.
• The subject is ≥ 18 years and ≤ 80 years.
• Both sexes.
• The subject's primary anesthesia care team has planned for a spinal anesthesia.
• The patient agrees to receive an adductor canal block.
• ASA class 1-3.

You may not qualify if:

• Subject is \< 18 years of age or \>80 years of age.
• Subject is known or believed to be pregnant.
• Significant pre-existing neuropathy on the operative limb.
• Significant renal, cardiac or hepatic disease.
• ASA class 4-5.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.

  PMID: 10422923 BACKGROUND

• Allen HW, Liu SS, Ware PD, Nairn CS, Owens BD. Peripheral nerve blocks improve analgesia after total knee replacement surgery. Anesth Analg. 1998 Jul;87(1):93-7. doi: 10.1097/00000539-199807000-00020.

  PMID: 9661553 BACKGROUND

• Hadzic A, Houle TT, Capdevila X, Ilfeld BM. Femoral nerve block for analgesia in patients having knee arthroplasty. Anesthesiology. 2010 Nov;113(5):1014-5. doi: 10.1097/ALN.0b013e3181f4b43d. No abstract available.

  PMID: 20881593 BACKGROUND

• Wang H, Boctor B, Verner J. The effect of single-injection femoral nerve block on rehabilitation and length of hospital stay after total knee replacement. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):139-44. doi: 10.1053/rapm.2002.29253.

  PMID: 11915059 BACKGROUND

• Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.

  PMID: 9661552 BACKGROUND

• YaDeau JT, Cahill JB, Zawadsky MW, Sharrock NE, Bottner F, Morelli CM, Kahn RL, Sculco TP. The effects of femoral nerve blockade in conjunction with epidural analgesia after total knee arthroplasty. Anesth Analg. 2005 Sep;101(3):891-895. doi: 10.1213/01.ANE.0000159150.79908.21.

  PMID: 16116010 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine; Saline Solution; Ketamine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Ehab Samir, MD

CONTACT

01003078676; hobasamir12@gmail.com

Mohamed Galal, Prof.

CONTACT

01062011126; galalm1967@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 8, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02