Comparison of the Effects of Epidural Analgesia and Local Infiltrative Analgesia Methods on Pain Control
Condition: Epidural Anesthesia
Study type: Interventional

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 (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.
    

Intervention name(s): 18-Gauge Touhy (Egemen®, Combifix Standard Spinal Epidural Combined Set, İzmir, Turkey); 20-gauge infiltrative analgesia catheter connected to an ON-Q elastomeric pump
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: analgesia; knee arthroplasty; epidural; infiltrative; stress