Effect of Low-dose Epidural Morphine Combined With Single-injection Femoral Nerve Block on Postoperative Analgesia in Patients After Total Knee Arthroplasty
Sponsor study identifier
interventional
110
1 country
1
Study Start
July 1, 2017
Actual (reported)Primary Completion
April 30, 2018
Actual (reported)Study Completion
May 30, 2018
Actual (reported)Single femoral nerve blockade combined with patient-controlled intravenous analgesia are used for postoperative analgesia for patients after TKA in the hospital of the investigators. Although this method provides acceptable analgesia, the incidence of opioid-associated side effects is relatively high. Low-dose epidural morphine is commonly used in postoperative analgesia after cesarean section, and the effect of single dose morphine lasts more than 20 hours, with low incidences of itching, nausea, vomiting, and respiratory depression. The investigators hypothesize that, for patients undergoing TKA, the addition of low-dose epidural morphine to single femoral nerve block and intravenous opioids can improve the postoperative analgesia, reduce the consumption of intravenous opioids and decrease opioid-associated side effects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 30, 2017
Actual (reported)June 29, 2017
Actual (reported)July 1, 2017
Actual (reported)April 30, 2018
Actual (reported)May 30, 2018
Actual (reported)Percent of patients with moderate to severe pain (Numeric Rating Scale pain score of 4 or higher)
Pain severity is evaluated with Numeric Rating Scale (NRS, an 11-point scale where 0 = no pain and 10 = the worst pain) both at rest and with movement.
Until 48 hours after surgery.
NRS pain scores (at rest and with movement) at various timepoints after surgery
At 6, 12, 24, 36 and 48 hours after surgery.
Cumulative morphine consumption
Until 48 hours after surgery.
1. Epidural morphine (2 mg morphine in 5 ml normal saline) is administered through the epidural catheter at the end of surgery. 2. Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery. 3. Intravenous morphine analgesia is provided with a patient-controlled analgesia pump which is established with 100 ml of 0.5 mg/mL morphine, programmed to deliver a 2 ml bolus with a lockout interval of 8-10 min and a background infusion of 0.5 mL/h.
1. Epidural placebo (5 ml normal saline) is administered through the epidural catheter at the end of surgery. 2. Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery. 3. Intravenous morphine analgesia is provided with a patient-controlled analgesia pump which is established with 100 ml of 0.5 mg/mL morphine, programmed to deliver a 2 ml bolus with a lockout interval of 8-10 min and a background infusion of 0.5 mL/h.
2 mg of morphine (0.4 mg/ml morphine in 5 ml normal saline) is administered through the epidural catheter at the end of surgery.
5 ml normal saline is administered through the epidural catheter at the end of surgery.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Control intervention
Epidural placebo
The registry describes a control or simulated intervention. Active treatment exposure is not inferred.
View registry recordAdministration procedure
Intravenous morphine analgesia
The registry describes an administration procedure or treatment schedule. Actual exposure and doses are not established by this entry.
View registry recordPeking University First Hospital
Beijing, Beijing Municipality, 100034, China
Lamplot JD, Wagner ER, Manning DW. Multimodal pain management in total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Feb;29(2):329-34. doi: 10.1016/j.arth.2013.06.005. Epub 2013 Jul 11.
Dong CC, Dong SL, He FC. Comparison of Adductor Canal Block and Femoral Nerve Block for Postoperative Pain in Total Knee Arthroplasty: A Systematic Review and Meta-analysis. Medicine (Baltimore). 2016 Mar;95(12):e2983. doi: 10.1097/MD.0000000000002983.
Dong-Xin Wang, MD,PhD
Peking University First Hospital
110 participants (actual enrollment reported by the registry).
First Submitted
May 30, 2017
First Posted
June 29, 2017
Study Start
July 1, 2017
Actual (reported)Forced-Air Warming for Preventing Perioperative Hypot
Recovery of motor function of the lower limb from blockade
At the end of the surgery and at 0.5, 6, 12, 24, 36, 48 hours after surgery.
Time to begin functional exercise and ground walking
During hospital stay, up to 1 week after surgery.
Patient's satisfaction with analgesia
At 48 hours after surgery.
Single femoral nerve block is performed with 20 ml 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery.
Intravenous morphine analgesia is provided with a patient-controlled analgesia pump which is established with 100 ml of 0.5 mg/ml morphine, programmed to deliver a 2 ml bolus with a lockout interval of 8-10 min and a background infusion of 0.5 ml/h.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Pulos N, Sheth N. Perioperative pain management following total joint arthroplasty. Ann Orthop Rheumatol. 2014;2(3):1029.Google Scholar
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Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
Wang H, Boctor B, Verner J. The effect of single-injection femoral nerve block on rehabilitation and length of hospital stay after total knee replacement. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):139-44. doi: 10.1053/rapm.2002.29253.
Bonica J. Postoperative pain. In: Bonica J, editor. The Management of Pain. 2nd ed. Philadelphia: Lea & Febiger; 1990. p. 461-80.
Pang WW, Hsu TC, Tung CC, Hung CP, Chang DP, Huang MH. Is total knee replacement more painful than total hip replacement? Acta Anaesthesiol Sin. 2000 Sep;38(3):143-8.
Chughtai M, Jauregui JJ, Mistry JB, Elmallah RK, Diedrich AM, Bonutti PM, Delanois R, Mont MA. What Influences How Patients Rate Their Hospital After Total Knee Arthroplasty? Surg Technol Int. 2016 Apr;28:261-5.
Lavie LG, Fox MP, Dasa V. Overview of Total Knee Arthroplasty and Modern Pain Control Strategies. Curr Pain Headache Rep. 2016 Nov;20(11):59. doi: 10.1007/s11916-016-0592-6.
Seet E, Leong WL, Yeo AS, Fook-Chong S. Effectiveness of 3-in-1 continuous femoral block of differing concentrations compared to patient controlled intravenous morphine for post total knee arthroplasty analgesia and knee rehabilitation. Anaesth Intensive Care. 2006 Feb;34(1):25-30. doi: 10.1177/0310057X0603400110.
Tierney E, Lewis G, Hurtig JB, Johnson D. Femoral nerve block with bupivacaine 0.25 per cent for postoperative analgesia after open knee surgery. Can J Anaesth. 1987 Sep;34(5):455-8. doi: 10.1007/BF03014348.
Weber A, Fournier R, Van Gessel E, Gamulin Z. Sciatic nerve block and the improvement of femoral nerve block analgesia after total knee replacement. Eur J Anaesthesiol. 2002 Nov;19(11):834-6. doi: 10.1017/s0265021502221353. No abstract available.
Mansour NY, Bennetts FE. An observational study of combined continuous lumbar plexus and single-shot sciatic nerve blocks for post-knee surgery analgesia. Reg Anesth. 1996 Jul-Aug;21(4):287-91.
Sundarathiti P, Ruananukul N, Channum T, Kitkunasathean C, Mantay A, Thammasakulsiri J, Sodsee W. A comparison of continuous femoral nerve block (CFNB) and continuous epidural infusion (CEI) in postoperative analgesia and knee rehabilitation after total knee arthroplasty (TKA). J Med Assoc Thai. 2009 Mar;92(3):328-34.
Popping DM, Zahn PK, Van Aken HK, Dasch B, Boche R, Pogatzki-Zahn EM. Effectiveness and safety of postoperative pain management: a survey of 18 925 consecutive patients between 1998 and 2006 (2nd revision): a database analysis of prospectively raised data. Br J Anaesth. 2008 Dec;101(6):832-40. doi: 10.1093/bja/aen300. Epub 2008 Oct 22.
Duarte VM, Fallis WM, Slonowsky D, Kwarteng K, Yeung CK. Effectiveness of femoral nerve blockade for pain control after total knee arthroplasty. J Perianesth Nurs. 2006 Oct;21(5):311-6. doi: 10.1016/j.jopan.2006.05.011.
Salinas FV, Liu SS, Mulroy MF. The effect of single-injection femoral nerve block versus continuous femoral nerve block after total knee arthroplasty on hospital length of stay and long-term functional recovery within an established clinical pathway. Anesth Analg. 2006 Apr;102(4):1234-9. doi: 10.1213/01.ane.0000198675.20279.81.
Soto Mesa D, Del Valle Ruiz V, Fayad Fayad M, Cosio Carreno F, Blanco Rodriguez I, Gonzalez Castano R, Bermejo Alvarez MA. [Control of postoperative pain in knee arthroplasty: single dose femoral nerve block versus continuous femoral block]. Rev Esp Anestesiol Reanim. 2012 Apr;59(4):204-9. doi: 10.1016/j.redar.2012.02.013. Epub 2012 Apr 30. Spanish.
Singh SI, Rehou S, Marmai KL, Jones APM. The efficacy of 2 doses of epidural morphine for postcesarean delivery analgesia: a randomized noninferiority trial. Anesth Analg. 2013 Sep;117(3):677-685. doi: 10.1213/ANE.0b013e31829cfd21. Epub 2013 Aug 6.
Marroquin B, Feng C, Balofsky A, Edwards K, Iqbal A, Kanel J, Jackson M, Newton M, Rothstein D, Wong E, Wissler R. Neuraxial opioids for post-cesarean delivery analgesia: can hydromorphone replace morphine? A retrospective study. Int J Obstet Anesth. 2017 May;30:16-22. doi: 10.1016/j.ijoa.2016.12.008. Epub 2016 Dec 30.
Sundarathiti P, Thammasakulsiri J, Supboon S, Sakdanuwatwong S, Piangjai M. Comparison of continuous femoral nerve block (CFNB/SA) and continuous femoral nerve block with mini-dose spinal morphine (CFNB/SAMO) for postoperative analgesia after total knee arthroplasty (TKA): a randomized controlled study. BMC Anesthesiol. 2016 Jul 16;16(1):38. doi: 10.1186/s12871-016-0205-2.
Meng ZT, Cui F, Li XY, Wang DX. Epidural morphine improves postoperative analgesia in patients after total knee arthroplasty: A randomized controlled trial. PLoS One. 2019 Jul 1;14(7):e0219116. doi: 10.1371/journal.pone.0219116. eCollection 2019.
Primary Completion
April 30, 2018
Actual (reported)Study Completion
May 30, 2018
Actual (reported)Last Updated
June 4, 2018
Record last verified: 2018-05
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