Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05344079
Status:
COMPLETED
Last Update Posted:
2022-04-29
First Post:
2022-04-18
Brief Title:
Comparison of the Effects of Epidural Analgesia and Local Infiltrative Analgesia Methods on Pain Control
Sponsor:
Samsun Education and Research Hospital
Organization:
Samsun Education and Research Hospital
Study Overview
Official Title:
Comparison of Epidural Analgesia and Local Infiltrative Analgesia
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 n25 and group I local infiltrative analgesia n26 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 05 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 12000000 adrenaline test dose At the end of the surgery when the Bromage score is 2 in the recovery room 60 mL 09 NaCl 05 60 mL bupivacaine Marcaine 05 AstraZeneca Industry and Trade Ltd was inserted into the epidural catheter to provide continuous infusion at a rate of 5 mLhour 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 05 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 mLhour infusion prepared with 60 mL of 09 NaCl 60 mL of 05 Bupivacaine Marcaine 05 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 0absent 1mild 2severe and vomiting 0absent 1mild 2severe 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
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 n25 and group I local infiltrative analgesia n26 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 05 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 12000000 adrenaline test dose At the end of the surgery when the Bromage score is 2 in the recovery room 60 mL 09 NaCl 05 60 mL bupivacaine Marcaine 05 AstraZeneca Industry and Trade Ltd was inserted into the epidural catheter to provide continuous infusion at a rate of 5 mLhour 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 05 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 mLhour infusion prepared with 60 mL of 09 NaCl 60 mL of 05 Bupivacaine Marcaine 05 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 0absent 1mild 2severe and vomiting 0absent 1mild 2severe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None