Epidural AnesthesiaNCT05344079
Comparison of the Effects of Epidural Analgesia and Local Infiltrative Analgesia Methods on Pain Control
A study testing 18-Gauge Touhy (Egemen®, Combifix Standard Spinal Epidural Combined Set, İzmir, Turkey) and 20-gauge infiltrative analgesia catheter connected to an ON-Q elastomeric pump in people with Epidural Anesthesia, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epidural Anesthesia
- What is being tested?
- 18-Gauge Touhy (Egemen®, Combifix Standard Spinal Epidural Combined Set, İzmir, Turkey) and 20-gauge infiltrative analgesia catheter connected to an ON-Q elastomeric pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2016to 1 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA II and III,
- Aged between 18-80 years,
- who were scheduled to undergo unilateral knee arthroplasty,
- who giving consent.
Who cannot join
- 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,
Show all 9Show fewer
- had a history of cerebrovascular disease,
- who received steroid therapy for any disease, were diabetic,
- had a homeostasis assessment score (HOMA) above 2.5.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Research and Education Hospital
Samsun, 55090
About this study
Official title: Comparison of Epidural Analgesia and Local Infiltrative Analgesia
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.
Read the detailed description
The study was planned as a prospective, randomized and single-center study, and the study was started after the approval of the local ethics committee. Informed consent form was obtained from each participants. All surgeries were performed before 11 am to ensure that the measurements of endocrine parameters matched the diurnal rhythm.
A total of 51 ASA I-III participants scheduled for TKA were randomly divided into two groups using the closed envelope method. Groups were group E administered epidural analgesia (n=25) and group I local infiltrative analgesia (n=26). After an overnight fasting period, the participants who were taken to the operating room were hydrated with 500 mL of saline 30 minutes before the operation, and no premedication was applied to the patients. When the participants were taken to the operating table, routine ECG (DII), non-invasive blood pressure, and peripheral oxygen saturation were monitored.
The same surgical technique was performed by the same surgeon in both groups. The same prosthesis was used in both groups, 750 mg cefuroxime iv. for prophylactic antibiotics (Cefax; Vem Pharmaceutical Industry and Trade Ltd.) and the patients were administered diclofenac sodium 75 mg regularly every 12 hours (Diclomec; Abdi İbrahim Pharmaceuticals Ind. and Trade Inc.).
Group E: Participants 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; Braun) 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 Industry and Trade Ltd.). 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; Osel Pharmaceuticals Ind. Inc.) + 1/2000000 adrenaline test dose. At the end of the surgery, when the Bromage score is 2 in the recovery room, 60 mL 0.9% NaCl + 0.5% 60 mL bupivacaine (Marcaine 0.5%; AstraZeneca Industry and Trade Ltd.) was inserted into the epidural catheter to provide continuous infusion at a rate of 5 mL/hour, and the participants were followed in the postanesthetic care unit for 24 hours.
Group I: In this group, 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. When the Bromage score was 2 in the postoperative recovery room, drug infusion was started with an incisional pain pump and the catheter was withdrawn at the end of the postoperative 24th hour.
Bromage score used in participants in the epidural analgesia group; 0: No paralysis, the patient can move his foot and knee fully; 1: The patient only moves his knee and foot, cannot raise his leg straight; 2: The patient cannot move the knee, only the ankle; 3: It was evaluated as complete paralysis.
In the postoperative period in participants 4th, 6th, 12th, pain at rest and with movement (passive flexion movement to the knee joint at the operation site) was measured with the Visual Analog Scale (VAS) at the 24th. VAS assessment was done by asking the participants 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. In both groups, if the VAS value is 4 and above, 50 mg iv. tramadol hydrochloride (Contromal; Abdi İbrahim Pharmaceuticals Ind. and Trade Inc.) additional dose was administered.
Tramadol hydrochloride consumption and side effects were evaluated as nausea (0=absent, 1=mild, 2=severe) and vomiting (0=absent, 1=mild, 2=severe). The presence of urinary retention and abdominal distension was recorded. Venous blood samples were taken in the preoperative period, at the 1st hour, 4th hour, and 24th hour postoperatively to evaluate the stress response.
- Conditions
- Epidural Anesthesia
- Being tested
- 18-Gauge Touhy (Egemen®, Combifix Standard Spinal Epidural Combined Set, İzmir, Turkey), 20-gauge infiltrative analgesia catheter connected to an ON-Q elastomeric pump
- Keywords
- analgesia, knee arthroplasty, epidural, infiltrative, stress
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
20-gauge infiltrative analgesia catheter connected to an ON-Q elastomeric pumpDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: 20-gauge infiltrative analgesia catheter connected to an ON-Q elastomeric pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 4 hours to 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 May 2016
- Primary completion3 Mar 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Epidural AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hale Kefeli Celik, Samsun Education and Research Hospital
- Investigators
- Zahide Doganay, Professor, Study chair, Samsun Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344079
- Sponsor's protocol ID
- KAEK-16/03-LIA
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researched data and statistical analyzes will be available from the journal in which the clinical study was published.
Publications
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.
PubMed 30021587Peng 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.
PubMed 32481477Gibbison 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.
PubMed 23661405Fusco 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.
PubMed 28984095Li 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.
PubMed 29769140
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Epidural Analgesia and Local Infiltrative Analgesia
- ClinicalTrials.gov ID
- NCT05344079
- Acronym / sponsor ID
- KAEK-16/03-LIA
- Conditions
- Epidural Anesthesia
- Keywords
- analgesia, knee arthroplasty, epidural, infiltrative, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Samsun Education and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 3 Mar 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study was planned as a prospective, randomized and single-center study, and the study was started after the approval of the local ethics committee. Informed consent form was obtained from each participants. All surgeries were performed before 11 am to ensure that the measurements of endocrine parameters matched the diurnal rhythm.
A total of 51 ASA I-III participants scheduled for TKA were randomly divided into two groups using the closed envelope method. Groups were group E administered epidural analgesia (n=25) and group I local infiltrative analgesia (n=26). After an overnight fasting period, the participants who were taken to the operating room were hydrated with 500 mL of saline 30 minutes before the operation, and no premedication was applied to the patients. When the participants were taken to the operating table, routine ECG (DII), non-invasive blood pressure, and peripheral oxygen saturation were monitored.
The same surgical technique was performed by the same surgeon in both groups. The same prosthesis was used in both groups, 750 mg cefuroxime iv. for prophylactic antibiotics (Cefax; Vem Pharmaceutical Industry and Trade Ltd.) and the patients were administered diclofenac sodium 75 mg regularly every 12 hours (Diclomec; Abdi İbrahim Pharmaceuticals Ind. and Trade Inc.).
Group E: Participants 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; Braun) 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 Industry and Trade Ltd.). 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; Osel Pharmaceuticals Ind. Inc.) + 1/2000000 adrenaline test dose. At the end of the surgery, when the Bromage score is 2 in the recovery room, 60 mL 0.9% NaCl + 0.5% 60 mL bupivacaine (Marcaine 0.5%; AstraZeneca Industry and Trade Ltd.) was inserted into the epidural catheter to provide continuous infusion at a rate of 5 mL/hour, and the participants were followed in the postanesthetic care unit for 24 hours.
Group I: In this group, 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. When the Bromage score was 2 in the postoperative recovery room, drug infusion was started with an incisional pain pump and the catheter was withdrawn at the end of the postoperative 24th hour.
Bromage score used in participants in the epidural analgesia group; 0: No paralysis, the patient can move his foot and knee fully; 1: The patient only moves his knee and foot, cannot raise his leg straight; 2: The patient cannot move the knee, only the ankle; 3: It was evaluated as complete paralysis.
In the postoperative period in participants 4th, 6th, 12th, pain at rest and with movement (passive flexion movement to the knee joint at the operation site) was measured with the Visual Analog Scale (VAS) at the 24th. VAS assessment was done by asking the participants 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. In both groups, if the VAS value is 4 and above, 50 mg iv. tramadol hydrochloride (Contromal; Abdi İbrahim Pharmaceuticals Ind. and Trade Inc.) additional dose was administered.
Tramadol hydrochloride consumption and side effects were evaluated as nausea (0=absent, 1=mild, 2=severe) and vomiting (0=absent, 1=mild, 2=severe). The presence of urinary retention and abdominal distension was recorded. Venous blood samples were taken in the preoperative period, at the 1st hour, 4th hour, and 24th hour postoperatively to evaluate the stress response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural | Active comparator | Device: 18-Gauge Touhy (Egemen®, Combifix Standard Spinal Epidural Combined Set, İzmir, Turkey)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. |
| local infiltrative analgesia | Active comparator | Device: 20-gauge infiltrative analgesia catheter connected to an ON-Q elastomeric pumpAt 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA II and III,
- Aged between 18-80 years,
- who were scheduled to undergo unilateral knee arthroplasty,
- who giving consent.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18-Gauge Touhy (Egemen®, Combifix Standard Spinal Epidural Combined Set, İzmir, Turkey)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. | Device | Epidural |
| 20-gauge infiltrative analgesia catheter connected to an ON-Q elastomeric pumpspinal 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. | Device | local infiltrative analgesia |
Primary outcome
Visual analog scale
Time frame: From 4 hours to 24 hours postoperative
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Results publication: PubMed 30021587Berninger 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.
- Results publication: PubMed 32481477Peng 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.
- Results publication: PubMed 23661405Gibbison 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.
- Results publication: PubMed 28984095Fusco 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.
- Results publication: PubMed 29769140Li 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.
- Individual participant dataSharing planned: No. Researched data and statistical analyzes will be available from the journal in which the clinical study was published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahide Doganay, Professor study chair
Samsun Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18-Gauge Touhy (Egemen®, Combifix Standard Spinal Epidural Combined Set, İzmir, Turkey) and 20-gauge infiltrative analgesia catheter connected to an ON-Q elastomeric pump in people with Epidural Anesthesia, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: From 4 hours to 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05344079, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.