Epidural Morphine for Postoperative Analgesia After Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

Effect of Low-dose Epidural Morphine Combined With Single-injection Femoral Nerve Block on Postoperative Analgesia in Patients After Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203967
• Other study ID #: 2017[1308]
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: May 2018
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Total knee arthroplasty (TKA) is an important therapy for patients with serious knee osteoarthritis in order to improve quality of life and relieve pain. But a large number of patients who undergo this surgery experience moderate to severe postoperative pain. Previously, the investigators used single femoral nerve blockade combined with patient-controlled intravenous analgesia for postoperative analgesia for patients after TKA. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Adult patients (age of 18 years or older);

• American Society of Anesthesiologists classification I-III;

• Scheduled to undergo unilateral TKA under combined spinal and epidural anesthesia.

Exclusion Criteria:

• Age higher than 90 years old;

• Presence of any contraindication to neuraxial block or peripheral nerve block;

• Continuous use of opioid analgesics during the last month;

• Unable to understand Numeric Rating Scale for pain evaluation or existence of language barrier;

• Severe renal insufficiency (requirement of renal replacement therapy);

• History of asthma;

• Recruited in another clinical trials.

Related Conditions & MeSH terms

• Adult Patients
• Analgesic Adverse Reaction
• Epidural Analgesia
• Femoral Nerve Block
• Total Knee Arthroplasty

Intervention

Procedure:
• Epidural morphine
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.
• Epidural placebo
5 ml normal saline is administered through the epidural catheter at the end of surgery.
• Single femoral nerve block
Single femoral nerve block is performed with 20 ml 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery.

Drug:
• Intravenous morphine analgesia
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.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (22)

Bonica J. Postoperative pain. In: Bonica J, editor. The Management of Pain. 2nd ed. Philadelphia: Lea & Febiger; 1990. p. 461-80.

Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Pöpping 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. — View Citation

Pulos N, Sheth N. Perioperative pain management following total joint arthroplasty. Ann Orthop Rheumatol. 2014;2(3):1029.Google Scholar

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. — View Citation

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. Erratum in: Anaesth Intensive Care. 2016 May;44(3):428-9. — View Citation

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. — View Citation

Singh SI, Rehou S, Marmai KL, Jones PM. The efficacy of 2 doses of epidural morphine for postcesarean delivery analgesia: a randomized noninferiority trial. Anesth Analg. 2013 Sep;117(3):677-85. doi: 10.1213/ANE.0b013e31829cfd21. Epub 2013 Aug 6. — View Citation

Soto Mesa D, Del Valle Ruiz V, Fayad Fayad M, Cosío Carreño F, Blanco Rodríguez I, González Castaño R, Bermejo Alvárez 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	NRS pain scores (at rest and with movement) at various timepoints after surgery	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.	At 6, 12, 24, 36 and 48 hours after surgery.
Secondary	Cumulative morphine consumption	Cumulative morphine consumption during 48 hours after surgery.	Until 48 hours after surgery.
Secondary	Recovery of motor function of the lower limb from blockade	Modified Bromage scale (0 = no blockade: extended limb lift off the bed; 1 = flexion/extension at knee and ankle joint; 2 = no flexion/extension at knee or ankle joint; 3 = complete blockade).	At the end of the surgery and at 0.5, 6, 12, 24, 36, 48 hours after surgery.
Secondary	Time to begin functional exercise and ground walking	Time to begin functional exercise and ground walking	During hospital stay, up to 1 week after surgery.
Secondary	Patient's satisfaction with analgesia	Evaluated in 5 scale, i.e., very satisfactory, satisfactory, neither satisfactory nor unsatisfactory, unsatisfactory, and very satisfactory.	At 48 hours after surgery.
Secondary	Length of stay in hospital after surgery	Length of stay in hospital after surgery	Until hospital discharge up to 30 days after surgery.
Secondary	Incidence of postoperative complication	Incidence of postoperative complication within 30 days after surgery.	Until 30 days after surgery.
Secondary	The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index	Evaluated with the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.	At 30 days after surgery.
Secondary	Quality of life (SF-12) at 30 days after surgery	Evaluated with Short-Form Health Survey-12 (SF-12) at 30 days after surgery.	At 30 days after surgery.