Comparison of the Effects of Epidural Analgesia and Local Infiltrative Analgesia Methods on Pain Control

NCT05344079 | Completed

• 1 other identifier: KAEK-16/03-LIA
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee arthroplasty (TKA) is one of the major orthopedic surgeries that cause severe postoperative pain. 60% of the patients undergoing TKA have severe pain and 30% have moderate pain postoperatively. Many methods are used in the effective treatment of pain after TKA. The administration of analgesic drugs to the wound site in the form of local infiltration is included in the pain treatment both as an independent technique and in addition to multimodal analgesia in the treatment of postoperative pain. Epidural analgesia (EA) is known for its place in the treatment of pain after TKA and its suppressive effect on the stress response. Similar to the study, no publication was found in the literature that evaluated the suppression of surgical stress response and the effectiveness of local infiltrative analgesia (LIA) in lower extremity surgery. Therefore, it was aimed in the study to compare the effects of EA and LIA on postoperative pain and stress response in patients who underwent total knee arthroplasty.

Conditions

Epidural Anesthesia

Keywords

analgesia; knee arthroplasty; epidural; infiltrative; stress

Outcome Measures

Primary Outcomes (1)

• Visual analog scale

  Following surgery, the patient's pain level will be recorded in a visual analog scale (VAS) at 4 hours, 6 hours, 12 hours, 24 hours. VAS assessment was done by asking the patient to mark a point on a 10 cm horizontal line that shows (initial "no pain", end "unbearable pain") the start and end points and is equivalent to the pain on this line.

  From 4 hours to 24 hours postoperative

Study Arms (2)

Epidural

ACTIVE COMPARATOR

Patients in this group were entered the epidural space from the midline using the loss of resistance method with an 18-Gauge Touhy (Egemen®, Combifix Standard Spinal Epidural Combined Set, İzmir, Turkey) needle from the L4-L5 or L5-S1 vertebral space.

Device: 18-Gauge Touhy (Egemen®, Combifix Standard Spinal Epidural Combined Set, İzmir, Turkey)

local infiltrative analgesia

ACTIVE COMPARATOR

At the end of the operation, a 20-gauge infiltrative analgesia catheter connected to an ON-Q elastomeric pump that provides 5 mL/hour infusion prepared with 60 mL of 0.9% NaCl + 60 mL of 0.5% Bupivacaine (Bustesin®, 0.5% Spinal Heavy Vem Pharmaceuticals, Turkey) was placed on the fascia by the surgeon in such a way that all the holes of the catheter were under the skin and parallel to the incision line.

Device: 20-gauge infiltrative analgesia catheter connected to an ON-Q elastomeric pump

Interventions

18-Gauge Touhy (Egemen®, Combifix Standard Spinal Epidural Combined Set, İzmir, Turkey) DEVICE

Patients in this group were entered the epidural space from the midline using the loss of resistance method with an 18-Gauge Touhy (Egemen®, Combifix Standard Spinal Epidural Combined Set, İzmir, Turkey) needle from the L4-L5 or L5-S1 vertebral space. After the free cerebrospinal fluid flow is observed by passing the spinal needle through the epidural needle, spinal anaesthesia was maintained with 10-15 mg hyperbaric bupivacaine (Bustesin®, 0.5% Spinal Heavy Vem Pharmaceuticals, Turkey). After the epidural catheter was fixed in such a way that it remained 5 cm in the epidural space, the adapter was inserted and fixed. Whether the catheter is in place or not was checked by 2 mL (40 mg) Lidocaine (Aritmal®, 2% 100 mg/5 mL amp., Biosel, Turkey) + 1/2000000 adrenaline test dose.

Epidural

20-gauge infiltrative analgesia catheter connected to an ON-Q elastomeric pump DEVICE

spinal anesthesia was maintained with 10-15 mg of hyperbaric bupivacaine (Bustesin 0.5% Spinal Heavy; Vem Pharmaceutical Industry and Trade Ltd.) after free cerebrospinal fluid flow was observed by entering the subarachnoid space with a 22 G spinal needle (Egemen Quincke Sharpened Spinal Anesthesia Needle; İzmir) from the L4-L5 or L5-S1 vertebral space. At the end of the operation, a 20-gauge infiltrative analgesia catheter connected to an ON-Q elastomeric pump that provides 5 mL/hour infusion prepared with 60 mL of 0.9% NaCl + 60 mL of 0.5% Bupivacaine (Marcaine 0.5%; AstraZeneca Industry and Trade Ltd.) was placed on the fascia by the surgeon in such a way that all the holes of the catheter were under the skin and parallel to the incision line. Pain pump and the catheter was withdrawn at the end of the postoperative 24th hour.

local infiltrative analgesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: It is known that gender difference is different in both stress response and pain perception. Therefore, only female patients and patients who will undergo a single TKA were included in the study in order to standardize the study. (Rosen S, Ham B, Mogil JS. Sex differences in neuroimmunity and pain. J Neurosci Res 2017;95:500-508)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA II and III,
• Aged between 18-80 years,
• who were scheduled to undergo unilateral knee arthroplasty,
• who giving consent.

You may not qualify if:

• who will undergo an extra surgical procedure or who will undergo bilateral knee arthroplasty,
• those with local anaesthetic sensitivity,
• morbidly obese,
• those with additional pathology that may constitute a contraindication to the application of regional anaesthesia,
• those who did not give voluntary consent,
• had a history of anticoagulant drug use,
• had a history of cerebrovascular disease,
• who received steroid therapy for any disease, were diabetic,
• had a homeostasis assessment score (HOMA) above 2.5.

Sponsors & Collaborators

• Samsun Education and Research Hospital: lead

Study Sites (1)

Samsun Research and Education Hospital

Samsun, 55090, Turkey (Türkiye)

Location

Related Publications (5)

• Berninger MT, Friederichs J, Leidinger W, Augat P, Buhren V, Fulghum C, Reng W. Effect of local infiltration analgesia, peripheral nerve blocks, general and spinal anesthesia on early functional recovery and pain control in total knee arthroplasty. BMC Musculoskelet Disord. 2018 Jul 18;19(1):232. doi: 10.1186/s12891-018-2154-z.

  PMID: 30021587 RESULT

• Peng XQ, Fei ZG, Sun CG, Zhou QJ. Efficacy and safety of local infiltration analgesia for pain management in total knee and hip arthroplasty: A meta-analysis of randomized controlled trial. Medicine (Baltimore). 2020 May 29;99(22):e20640. doi: 10.1097/MD.0000000000020640.

  PMID: 32481477 RESULT

• Gibbison B, Angelini GD, Lightman SL. Dynamic output and control of the hypothalamic-pituitary-adrenal axis in critical illness and major surgery. Br J Anaesth. 2013 Sep;111(3):347-60. doi: 10.1093/bja/aet077. Epub 2013 May 9.

  PMID: 23661405 RESULT

• Fusco P, Cofini V, Petrucci E, Scimia P, Fiorenzi M, Paladini G, Behr AU, Borghi B, Flamini S, Pizzoferrato R, Colafarina O, Di Francesco A, Tabacco T, Necozione S, Marinangeli F. Continuous wound infusion and local infiltration analgesia for postoperative pain and rehabilitation after total hip arthroplasty. Minerva Anestesiol. 2018 May;84(5):556-564. doi: 10.23736/S0375-9393.17.12110-3. Epub 2017 Oct 4.

  PMID: 28984095 RESULT

• Li C, Qu J, Pan S, Qu Y. Local infiltration anesthesia versus epidural analgesia for postoperative pain control in total knee arthroplasty: a systematic review and meta-analysis. J Orthop Surg Res. 2018 May 16;13(1):112. doi: 10.1186/s13018-018-0770-9.

  PMID: 29769140 RESULT

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

• Zahide Doganay, Professor

  Samsun Research and Education Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Principal Investigator

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 25, 2022
• Study Start: May 1, 2016
• Primary Completion: March 3, 2017
• Study Completion: May 1, 2017
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)