RecruitingPhase 4ACTRN12616000912482

Postoperative analgesia for elective total knee arthroplasty

Postoperative analgesia for elective total knee arthroplasty under subarachnoid anesthesia with opioids: comparison between epidural, femoral block and adductor canal block techniques.


Sponsor

Hospital Complex of Navarra

Enrollment

500 participants

Start Date

Jul 21, 2016

Study Type

Interventional

Conditions

Summary

Total knee arthroplasty (TKA) is a highly distressful major surgery, with a significant potential for complications, not only because of the surgical and anesthetic impact of the procedure, but also because of the demographic and clinical characteristics of the target population. Ideal postoperative analgesia provides sufficient pain relief with minimal opioid consumption and preservation of motor strength to prevent postoperative complications. The application of multimodal techniques including regional anesthesia are broadly used to meet such expectations. In this study, we evaluate the effect of 10 different postoperative regional analgesic techniques in patients undergoing elective TKA with subarachnoid anesthesia: epidural, single-shot femoral nerve and adductor canal blocks, both with and without perineural nerve block adjuvants (dexamethasone, dexmedetomidine or buprenorphine). The main hypothesis was that nerve blocks improve postoperative analgesia, especially if perineurial adjuvants are added. The primary outcome, pain, is measured using a verbal rating 11–point scale for patient self-reporting of pain (VRS-11).


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for people having a total knee replacement. After the surgery, managing pain well is very important so patients can move around, avoid complications, and recover faster. This trial tests 10 different methods of pain relief — including nerve blocks and combinations of medications — to find out which approach works best. You may be eligible if: - You are 18 years of age or older - You are scheduled for a planned (elective) total knee replacement surgery You may NOT be eligible if: - You are having only a partial (unicompartmental) knee replacement - You refuse to participate - You have a medical reason why you cannot have spinal or regional anesthesia - You are allergic to any of the medications used in this study Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients scheduled for TKA under spinal anesthesia enrolled during preoperative anesthesia consultation. Written informed consent obtained from all patients willing to participate in this study. A

Patients scheduled for TKA under spinal anesthesia enrolled during preoperative anesthesia consultation. Written informed consent obtained from all patients willing to participate in this study. All patients will receive subarachnoid anesthesia in the sitting position at L3–4 or L4–5 interspace, with a 25-gauge Whitacre needle. We administer 0.5% hyperbaric bupivacaine (Hyperbaric bupivacaine 0.5% 'Registered Trademark', Braun) according to the following formula: bupivacaine (mg) = height (cm) x 0.07, with morphine (Morphine 0.1% 'Registered Trademark',, Braun) 0.15 mg and fentanyl (Fentanest 'Registered Trademark', Kern Pharma) 15 microg. Following injection, patients are immediately kept on lateral decubitus for 6 minutes to improve analgesia. There are 10 groups: - control group (without additional blocks). - epidural analgesia group (the subarachnoid anesthesia in these patients will be performed through the epidural needle at L3-4 or L4-5, the catheter advanced 3-4 cm and levobupivacaine (Chirocane 'Registered Trademark', Abbvie) 0.1% + fentanyl 2 microg.mL-1 (infusion rate 6-10 mL.h-1, bolus volume 5 mL, lock interval 30 min). Epidural infusion is started at the end of surgery. - femoral nerve block with 20 ml of levobupivacaine 0.375%, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again. - femoral block with 20 ml of levobupivacaine 0.375% and dexamethasone (Fortecortin 'Registered Trademark', Merck) 4 mg, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again. - femoral block with 20 ml of levobupivacaine 0.375% and dexmedetomidine (Dexdor 'Registered Trademark', Orionpharma) 100 microg, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again. - femoral block with 20 ml of levobupivacaine 0.375% and buprenorphine (Buprex 'Registered Trademark', Schering-Plough) 150 microg, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again. - adductor canal block with 30 ml of levobupivacaine 0.375%, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again. - adductor canal block with 30 ml of levobupivacaine 0.375% and dexamethasone 4 mg, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again. - adductor canal block with 30 ml of levobupivacaine 0.375% and dexmedetomidine (Dexdor 'Registered Trademark', Orionpharma) 100 microg, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again. - adductor canal block with 30 ml of levobupivacaine 0.375% and buprenorphine (Buprex 'Registered Trademark', Schering-Plough) 150 microg, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again. Surgeons and anesthesiologists are blinded to the addition of dexamethasone, dexmedetomidine or buprenorphine (perineural medication is prepared by a nurse adding 4 mg of dexamethasone, 100 microg of dexmedetomidine, 150 microg of buprenorphine or 1 ml of saline according to the randomized protocol). Nerve blocks are single-shots techniques performed under both ultrasound and nerve stimulation (considered adequate at 0.2-0.5 mA) by experienced anesthesiologists. All patients receive a standardized postoperative IV treatment: metamizole magnesium 8g/24 h, dexketoprofen 50 mg/12h. Postoperative analgesia begins immediately at the end of the surgery, when the patient is admitted to the PACU. The primary outcome, pain, is measured every hour (respecting the sleep period) during 24 h using a verbal rating 11–point scale for patient self-reporting of pain (VRS-11) previously explained to the patients: from 0 (“no pain”) to 10 (“the most horrible pain you can imagine; such as being burned alive”), and they are also advised to notify their nurse if they feel pain. Rescue analgesia when needed include: 1st: paracetamol 1 g, maximum 1g/6h/IV 2nd: Morphine 2 mg/15 min, maximum 10 mg/4h/IV Rescue blocks: femoral, sciatic and epidural


Locations(1)

Navarra, Madrid, Spain

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ACTRN12616000912482