Adult PatientsNCT03203967
Epidural Morphine for Postoperative Analgesia After Total Knee Arthroplasty
A study testing Epidural morphine, Single femoral nerve block and Intravenous morphine analgesia in people with Adult Patients and Total Knee Arthroplasty, run by Peking University First Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Adult Patients, Total Knee Arthroplasty, Epidural Analgesia
- What is being tested?
- Epidural morphine, Single femoral nerve block and Intravenous morphine analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 30 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Effect of Low-dose Epidural Morphine Combined With Single-injection Femoral Nerve Block on Postoperative Analgesia in Patients After Total Knee Arthroplasty
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.
Read the detailed 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.
- Conditions
- Adult Patients, Total Knee Arthroplasty, Epidural Analgesia, Femoral Nerve Block, Analgesic Adverse Reaction
- Being tested
- Epidural morphine, Epidural placebo, Single femoral nerve block, Intravenous morphine analgesia
- Keywords
- Adults, Unilateral TKA, Single femoral nerve block, Low-dose epidural morphine, Effect of postoperative analgesia, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural morphineProcedure or surgery
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 placeboProcedure or surgery
5 ml normal saline is administered through the epidural catheter at the end of surgery.
Single femoral nerve blockProcedure or 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 analgesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Epidural morphine | Experimental | 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. Receives: Procedure: Epidural morphine; Procedure: Single femoral nerve block; Drug: Intravenous morphine analgesia |
| Epidural placebo | Placebo comparator | 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. Receives: Procedure: Epidural placebo; Procedure: Single femoral nerve block; Drug: Intravenous morphine analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until 48 hours after surgery.
Secondary outcomes (9)
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.
Measured: At 6, 12, 24, 36 and 48 hours after surgery.
Cumulative morphine consumption
Cumulative morphine consumption during 48 hours after surgery.
Measured: Until 48 hours after surgery.
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).
Measured: 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
Time to begin functional exercise and ground walking
Measured: During hospital stay, up to 1 week after surgery.
Patient's satisfaction with analgesia
Evaluated in 5 scale, i.e., very satisfactory, satisfactory, neither satisfactory nor unsatisfactory, unsatisfactory, and very satisfactory.
Measured: At 48 hours after surgery.
Length of stay in hospital after surgery
Length of stay in hospital after surgery
Measured: Until hospital discharge up to 30 days after surgery.
Incidence of postoperative complication
Incidence of postoperative complication within 30 days after surgery.
Measured: Until 30 days after surgery.
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Evaluated with the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.
Measured: At 30 days after surgery.
Quality of life (SF-12) at 30 days after surgery
Evaluated with Short-Form Health Survey-12 (SF-12) at 30 days after surgery.
Measured: At 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start1 Jul 2017
- Primary completion30 Apr 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Adult PatientsStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD,PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203967
- Sponsor's protocol ID
- 2017[1308]
- Status last verified
- May 2018
- First submitted
- 30 May 2017
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23850410Dong 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.
PubMed 27015172Pulos N, Sheth N. Perioperative pain management following total joint arthroplasty. Ann Orthop Rheumatol. 2014;2(3):1029.Google Scholar
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. doi: 10.1097/00000542-199907000-00006.
PubMed 10422923Singelyn 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.
PubMed 9661552Wang 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.
PubMed 11915059Bonica 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.
PubMed 11125689Chughtai 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.
PubMed 27042784Lavie 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.
PubMed 27655139Seet 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.
PubMed 16494145Tierney 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.
PubMed 3664912Weber 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.
PubMed 12442936Mansour 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.
PubMed 8837184Sundarathiti 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.
PubMed 19301724
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-dose Epidural Morphine Combined With Single-injection Femoral Nerve Block on Postoperative Analgesia in Patients After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03203967
- Acronym / sponsor ID
- 2017[1308]
- Conditions
- Adult Patients, Total Knee Arthroplasty, Epidural Analgesia, Femoral Nerve Block, Analgesic Adverse Reaction
- Keywords
- Adults, Unilateral TKA, Single femoral nerve block, Low-dose epidural morphine, Effect of postoperative analgesia, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural morphine | Experimental | Procedure: Epidural morphine, Procedure: Single femoral nerve block, Drug: Intravenous morphine analgesia1. 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. |
| Epidural placebo | Placebo comparator | Procedure: Epidural placebo, Procedure: Single femoral nerve block, Drug: Intravenous morphine analgesia1. 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural morphine2 mg of morphine (0.4 mg/ml morphine in 5 ml normal saline) is administered through the epidural catheter at the end of surgery. | Procedure or surgery | Epidural morphine |
| Epidural placebo5 ml normal saline is administered through the epidural catheter at the end of surgery. | Procedure or surgery | Epidural placebo |
| Single femoral nerve blockSingle femoral nerve block is performed with 20 ml 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery. | Procedure or surgery | Epidural morphine, Epidural placebo |
| Intravenous morphine analgesiaIntravenous 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. | Drug | Epidural morphine, Epidural placebo |
Primary outcome
Percent of patients with moderate to severe pain (Numeric Rating Scale pain score of 4 or higher)
Time frame: Until 48 hours 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.
9 secondary outcomes
NRS pain scores (at rest and with movement) at various timepoints after surgery
Time frame: At 6, 12, 24, 36 and 48 hours after surgery.
Cumulative morphine consumption
Time frame: Until 48 hours after surgery.
Recovery of motor function of the lower limb from blockade
Time frame: 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
Time frame: During hospital stay, up to 1 week after surgery.
Patient's satisfaction with analgesia
Time frame: At 48 hours after surgery.
Length of stay in hospital after surgery
Time frame: Until hospital discharge up to 30 days after surgery.
Incidence of postoperative complication
Time frame: Until 30 days after surgery.
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Time frame: At 30 days after surgery.
Quality of life (SF-12) at 30 days after surgery
Time frame: At 30 days after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Background: PubMed 23850410Lamplot 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.
- Background: PubMed 27015172Dong 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.
- BackgroundPulos N, Sheth N. Perioperative pain management following total joint arthroplasty. Ann Orthop Rheumatol. 2014;2(3):1029.Google Scholar
- Background: PubMed 10422923Capdevila 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. doi: 10.1097/00000542-199907000-00006.
- Background: PubMed 9661552Singelyn 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.
- Background: PubMed 11915059Wang 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.
- BackgroundBonica J. Postoperative pain. In: Bonica J, editor. The Management of Pain. 2nd ed. Philadelphia: Lea & Febiger; 1990. p. 461-80.
- Background: PubMed 11125689Pang 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.
- Background: PubMed 27042784Chughtai 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.
- Background: PubMed 27655139Lavie 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.
- Background: PubMed 16494145Seet 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.
- Background: PubMed 3664912Tierney 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-Xin Wang, MD,PhD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural morphine, Single femoral nerve block and Intravenous morphine analgesia in people with Adult Patients and Total Knee Arthroplasty, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients with moderate to severe pain (Numeric Rating Scale pain score of 4 or higher) (time frame: Until 48 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03203967, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.