Two Different Blocks for Postoperative Analgesia in Patients Undergoing Unilateral Total Knee Arthroplasty

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04286035
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 6
• Patients Per Site Per Month: 11.7

Study Details

Study Description

Brief Summary

The frequency of femoral nerve block and adductor canal block for analgesia after TKA(total knee arthroplasty) increases with the use of ultrasonography in regional anesthesia. In this study, we aimed to compare the effects of femoral nerve block and adductor canal block on postoperative analgesia in patients undergoing unilateral knee arthroplasty.

Condition or Disease	Intervention/Treatment	Phase
Knee Replacement, Total; Pain, Postoperative; Anesthesia, Regional	Drug: Bupivacaine Injection; Drug: Bupivacaine Injection	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Comparison of the Effects of Femoral Nerve Block and Adductor Canal Block on Postoperative Analgesia in Patients Undergoing Unilateral Total Knee Arthroplasty
• Actual Study Start Date: Apr 2, 2019
• Actual Primary Completion Date: Sep 29, 2019
• Actual Study Completion Date: Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Femoral group	Drug: Bupivacaine Injection; Femoral nerve block with 20 ml %0.375 bupivacaine
Active Comparator: Adductor group	Drug: Bupivacaine Injection; Adductor canal block with 20 ml %0.375 bupivacaine

Outcome Measures

Primary Outcome Measures

1. Tramadol consumption [24 hours after operation]

   Postoperative tramadol consumption with patient controlled analgesia

2. VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain) [24 hours after operation]

   VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain) is less than four is adequate analgesia

3. Rescue analgesic requirement [24 hours after operation]

   If VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain) is is four or more, paracetamol 1000 mg is administered

Secondary Outcome Measures

1. Postoperative nausea and vomiting [24 hours after operation]

   Frequency of postoperative nausea and vomiting

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• ASA(American Society of Anesthesiologists) Classification I-II

• Age: <55 years

• Unilateral total knee arthroplasty

Exclusion Criteria:

• Does not approve the study

• Pregnant

• Emergency

• ASA III-IV

• History of local anesthetic allergy

• Infection in the block area

• Coagulation disorder

• Morbid obesity (body mass index> 40 kg / m²)

• Severe organ failure

• Previous neurological deficit

• Psychiatric disease

• History of chronic pain

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SBÜ Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi	Istanbul		Turkey

Sponsors and Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kerim Şahin, Research assistant, Sisli Hamidiye Etfal Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT04286035
• Other Study ID Numbers: SK01
• First Posted: Feb 26, 2020
• Last Update Posted: Mar 13, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kerim Şahin, Research assistant, Sisli Hamidiye Etfal Training and Research Hospital: femoral nerve block, adductor canal block, total knee arthroplasty
• Additional relevant MeSH terms: Pain, Postoperative; Bupivacaine

Study Results

No Results Posted as of Mar 13, 2020