Pain ManagementNCT02576015

The Effect of Continuous Femoral Nerve Block With Modulation of Depth of Anesthesia on Prognosis of Patients Receiving Total Knee Arthroplasty

A study testing peri-operative continuous femoral nerve block with light sedation, post-operative continuous femoral nerve block and lidocaine in people with Pain Management and Sedation, run by Min Su at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Pain Management, Sedation, Peripheral Nerve Block
What is being tested?: peri-operative continuous femoral nerve block with light sedation, post-operative continuous femoral nerve block and lidocaine
Type of treatment: Injection or infusion, Medical device, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 380 participants
Where: 1 siteChina
Study dates: Mar 2016to Mar 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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women over the 18 years and younger than 80 years old
Scheduled to receive selective unilateral knee replacement.

Who cannot join

Bilateral knee replacement
The secondary knee revision and knee surgery not interfering with articular joint cavity (wound debridement and suture)
American Society of Anesthesiology (ASA) classification of anesthesia risk IV and V grade
Body mass index higher than 35
Coagulation dysfunction, which is assessed by activated partial thromboplastin time (APTT) higher than the upper limit by 10s; prothrombin time (PT) higher than the upper limit by 5s; International Normalized Ratio (INR) higher than 1.3, or any of criteria met above;
Pre-operative hypoxia (SpO2< 90% or PO2<60 mmHg)

Show all 11Show fewer

Pre-operative hypercapnia (PCO2> 50 mmHg)
Local infection of puncture sites
Neurological diseases and pre-operative psychological disorders
Uncontrolled general infection
Intra-operative cardiac arrest.

Trial locations and contacts

1 site in 1 country.

China1 site

The Department of Anesthesiology,the first Affiliated Hospital of Chongqing Medical University
Chonqqing, Chongqing Municipality, 400016
Lihua Peng, MD, 86-23-89011061, plhbest@163.com

Other trials in China

About this study

The interaction of analgesia and sedation ot their effect on the prognosis of surgical patients still need to be elucidated.Currently, how to optimize intra-operative Analgesia and sedation to improve the prognosis of surgical patients is still a mystery.Intra-operative nerve block provided regional analgesia of the operated knee, which reduced the dosages of sedatives and analgesics.Based on a pilot study,the investigators found a decrease of post-operative adverse composite outcomes with the use of continuous femoral nerve block (2% versus 7%) ,therefore, the investigators postulate that general analgesia with lighter sedation in combination with peripheral nerve block could reduce the post-operative morbidity compared with deeper sedation.This randomized controlled trial is designed to test this hypothesis in patients receiving unilateral knee arthroplasty.

Read the detailed description

This study was approved by the institutional review board of the First Affiliated Hospital of Chongqing Medical University. The protocol design is in accordance with Consolidated Standards of Reporting Trials (CONSORT) statement.This study is designed as a randomized controlled trial to compare intra-operative continuous femoral nerve block combined with lighter anesthetic depth (group L) with deeper anesthetic depth (group D) monitored by bispectral index (BIS). All potentially eligible participants will be asked to give written informed consent before they are enrolled in this study.The following outcomes will be assessed:post-operative major complications (post-operative pulmonary infection,need of mechanical respiratory support,myocardio-infarction,deep venous thrombosis, pulmonary embolism, stroke, poor wound healing,all-cause post-operative death within 30 days).Secondary Outcomes included :acute post-operative pain assessed by visual analogue scale and dosages of rescue medications;Dosages of intra-operative vasopressors,anesthetics and analgesics;Life quality measured by EQ-5D questionnaire 3 months post-operatively;adverse events associated with the femoral catheter (displacement, infection, hematoma,drop-out of catheter).

Conditions: Pain Management, Sedation, Peripheral Nerve Block, Total Knee Arthroplasty
Being tested: peri-operative continuous femoral nerve block with light sedation, post-operative continuous femoral nerve block, lidocaine, ultrasound, insulated needle (Contiplex B Braun, Melsungen, Germany)
Medical subject headings: Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

peri-operative continuous femoral nerve block with light sedationProcedure or surgery
this technique will be administered to participants in group L .The puncture site was identified using ultrasound guidance (2 cm distal to the inguinal ligament, and 1 ～2 cm lateral to the femoral artery).2% lidocaine was used for topical anesthesia, then an insulated needle (Contiplex B Braun, Melsungen, Germany) (20 G*45 mm，short bevel，30°) was connected to the nerve stimulator（Innervator，Fisher \&Paykel，New Zealand）.The parameters were as follows: stimulating intensity of 1 mA at a rate of 2 Hz. The needle was advanced at 30°～45° angle to the skin, until quadriceps femoral muscle twitches were elicited. Its position was accepted if contractions were still elicited when an output equal to 0.3 mA.The participants will receive continuous femoral nerve block intra-operatively and post-operatively till 3 days post-operatively.The depth of anesthesia will modulated at 50-60 with BIS monitoring
post-operative continuous femoral nerve blockProcedure or surgery
this technique will be administered to participants in group D .The puncture site was identified using ultrasound guidance (2 cm distal to the inguinal ligament, and 1 ～2 cm lateral to the femoral artery).2% lidocaine was used for topical anesthesia, then an insulated needle (Contiplex B Braun, Melsungen, Germany) (20 G*45 mm，short bevel，30°) was connected to the nerve stimulator（Innervator，Fisher \&Paykel，New Zealand）.The parameters were as follows: stimulating intensity of 1 mA at a rate of 2 Hz. The needle was advanced at 30°～45° angle to the skin, until quadriceps femoral muscle twitches were elicited. Its position was accepted if contractions were still elicited when an output equal to 0.3 mA.The participants will receive continuous femoral nerve block post-operatively till 3 days post-operatively.The depth of anesthesia will modulated at 30-40 with BIS monitoring
lidocaineDrug
ultrasoundDevice
insulated needle (Contiplex B Braun, Melsungen, Germany)Device
ropivacaineDrug
salineDrug

Study groups in NCT02576015
Study group	Role	What they receive
Group L	Experimental	Participants in group L will receive a single injection for femoral nerve block combined with continuous femoral nerve block intra-operatively. The femoral nerve block will be performed before the induction of anesthesia on the leg to be operated. Then the patients were given the 2% lidocaine 10 ml and 1% ropivacaine 10 ml as initial dose,then,the patients will receive a continuous infusion of 0.15% ropivacaine at 15 ml/h.Intra-operatively, bispectral index score (BIS) was titrated with the adjusting of desflurane to maintain the index between 50-60.After the surgery,these patients will receive continuous femoral nerve analgesia till 3 days post-operatively( the loading dose was set at 5 ml of 0.15% ropivacaine followed by an infusion of 0.15% ropivacaine at 5 ml/h, with bolus of 5 ml and the lock time of 30 min). Receives: Procedure: peri-operative continuous femoral nerve block with light sedation; Drug: lidocaine; Device: ultrasound; Device: insulated needle (Contiplex B Braun, Melsungen, Germany); Drug: ropivacaine
Group D	Sham comparator	Participants in group D will receive the placement of femoral nerve catheter preoperatively. The same dose of 0.9% saline was injected and infused as group L intra-operatively. Bispectral index score (BIS) was titrated with the adjusting of desflurane to maintain the index between 30-40.After the surgery,these patients will receive continuous femoral nerve analgesia till 3 days post-operatively( the loading dose was set at 5 ml of 0.15% ropivacaine followed by an infusion of 0.15% ropivacaine at 5 ml/h, with bolus of 5 ml and the lock time of 30 min). Receives: Procedure: post-operative continuous femoral nerve block; Device: ultrasound; Drug: ropivacaine; Drug: saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Major post-operative complications
Major post-operative complications summed the incidence of major complications post-operatively( (post-operative pulmonary infection,need of mechanical respiratory support,myocardio-infarction,deep venous thrombosis, pulmonary embolism, stroke, poor wound healing,all-cause post-operative death within 30 days),participants with at least one episode of the complications will be calculated as participants with complications,both the number of participants and number of events will be calculated.
Measured: From the end of surgery to 30 days post-operatively

Secondary outcomes (5)

Acute post-operative Pain assessed by visual analogue scale
Acute
Measured: At 12 hours ,24hours ,48hours,72 hours post-operatively
Dosages of rescue medications (mg)
the dosages of tramadol,pethidine and Parecoxib during the use of patient controlled analgesia (PCA) post-operatively
Measured: From the end of surgery to 3 days post-operatively
Dosages of intra-operative vasopressors,anesthetics and analgesics
Measured: during the surgery
Life quality measured by euro-quality-5 dimensions (EQ-5D)
EQ-5D is a commonly used scale for calibration of life quality
Measured: 3 months post-operatively
Adverse events associated with the femoral catheter
local infection,hematoma,drop-out of the catheter,nerve injury
Measured: From the insertion of the catheter to 3 days post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Mar 2018

First posted15 Oct 2015 (estimated)
Study startMar 2016
Primary completionMar 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Pain ManagementStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 380 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02576015
Sponsor's protocol ID: CYYYMZK-07
Status last verified: Oct 2015
First submitted: 8 Oct 2015
Last updated: 15 Oct 2015
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 9661552
Lieberman JR, Freiberg AA, Lavernia CJ. Practice management strategies among members of the American Association of Hip and Knee Surgeons. J Arthroplasty. 2012 Sep;27(8 Suppl):17-9.e1-6. doi: 10.1016/j.arth.2012.02.030. Epub 2012 Apr 12.
PubMed 22503334
Wegener JT, van Ooij B, van Dijk CN, Karayeva SA, Hollmann MW, Preckel B, Stevens MF. Long-term pain and functional disability after total knee arthroplasty with and without single-injection or continuous sciatic nerve block in addition to continuous femoral nerve block: a prospective, 1-year follow-up of a randomized controlled trial. Reg Anesth Pain Med. 2013 Jan-Feb;38(1):58-63. doi: 10.1097/AAP.0b013e318272523c.
PubMed 23104147
Morin AM, Kratz CD, Eberhart LH, Dinges G, Heider E, Schwarz N, Eisenhardt G, Geldner G, Wulf H. Postoperative analgesia and functional recovery after total-knee replacement: comparison of a continuous posterior lumbar plexus (psoas compartment) block, a continuous femoral nerve block, and the combination of a continuous femoral and sciatic nerve block. Reg Anesth Pain Med. 2005 Sep-Oct;30(5):434-45. doi: 10.1016/j.rapm.2005.05.006.
PubMed 16135347
Law CJ, Jacobson GM, Kluger M, Chaddock M, Scott M, Sleigh JW. Randomized controlled trial of the effect of depth of anaesthesia on postoperative pain. Br J Anaesth. 2014 Apr;112(4):675-80. doi: 10.1093/bja/aet419. Epub 2013 Dec 8.
PubMed 24322572
Baldini G, Bagry H, Carli F. Depth of anesthesia with desflurane does not influence the endocrine-metabolic response to pelvic surgery. Acta Anaesthesiol Scand. 2008 Jan;52(1):99-105. doi: 10.1111/j.1399-6576.2007.01470.x. Epub 2007 Nov 1.
PubMed 17976225
Soumpasis I, Kanakoudis F, Vretzakis G, Arnaoutoglou E, Stamatiou G, Iatrou C. Deep anaesthesia reduces postoperative analgesic requirements after major urological procedures. Eur J Anaesthesiol. 2010 Sep;27(9):801-6. doi: 10.1097/EJA.0b013e328337cbf4.
PubMed 20679774
Sahni N, Anand LK, Gombar K, Gombar S. Effect of intraoperative depth of anesthesia on postoperative pain and analgesic requirement: A randomized prospective observer blinded study. J Anaesthesiol Clin Pharmacol. 2012 Apr;28(2):266-7. doi: 10.4103/0970-9185.94920. No abstract available.
PubMed 22557763
Whitlock EL, Villafranca AJ, Lin N, Palanca BJ, Jacobsohn E, Finkel KJ, Zhang L, Burnside BA, Kaiser HA, Evers AS, Avidan MS. Relationship between bispectral index values and volatile anesthetic concentrations during the maintenance phase of anesthesia in the B-Unaware trial. Anesthesiology. 2011 Dec;115(6):1209-18. doi: 10.1097/ALN.0b013e3182395dcb.
PubMed 22037642
Kertai MD, Palanca BJ, Pal N, Burnside BA, Zhang L, Sadiq F, Finkel KJ, Avidan MS; B-Unaware Study Group. Bispectral index monitoring, duration of bispectral index below 45, patient risk factors, and intermediate-term mortality after noncardiac surgery in the B-Unaware Trial. Anesthesiology. 2011 Mar;114(3):545-56. doi: 10.1097/ALN.0b013e31820c2b57.
PubMed 21293252
Leslie K, Myles PS, Forbes A, Chan MT. The effect of bispectral index monitoring on long-term survival in the B-aware trial. Anesth Analg. 2010 Mar 1;110(3):816-22. doi: 10.1213/ANE.0b013e3181c3bfb2. Epub 2009 Nov 12.
PubMed 19910621
Punjasawadwong Y, Boonjeungmonkol N, Phongchiewboon A. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003843. doi: 10.1002/14651858.CD003843.pub2.
PubMed 17943802
Willingham MD, Karren E, Shanks AM, O'Connor MF, Jacobsohn E, Kheterpal S, Avidan MS. Concurrence of Intraoperative Hypotension, Low Minimum Alveolar Concentration, and Low Bispectral Index Is Associated with Postoperative Death. Anesthesiology. 2015 Oct;123(4):775-85. doi: 10.1097/ALN.0000000000000822.
PubMed 26267244
Gurman GM, Popescu M, Weksler N, Steiner O, Avinoah E, Porath A. Influence of the cortical electrical activity level during general anaesthesia on the severity of immediate postoperative pain in the morbidly obese. Acta Anaesthesiol Scand. 2003 Aug;47(7):804-8. doi: 10.1034/j.1399-6576.2003.00148.x.
PubMed 12859299
Peng J, Wang SD. Effect of anesthesia combined with intercostal nerve block on analgesia for esophageal cancer after operation. Eur Rev Med Pharmacol Sci. 2015 Jun;19(12):2293-6.
PubMed 26166657

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Continuous Femoral Nerve Block With Modulation of Depth of Anesthesia on Prognosis of Patients Receiving Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT02576015
Acronym / sponsor ID: CYYYMZK-07
Conditions: Pain Management, Sedation, Peripheral Nerve Block, Total Knee Arthroplasty
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 380 participants (estimated)
Lead sponsor: Min SuUniversity, hospital or other
Study start: Mar 2016
Primary completion: Mar 2018 (estimated)
First posted: 15 Oct 2015 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group L	Experimental	Procedure: peri-operative continuous femoral nerve block with light sedation, Drug: lidocaine, Device: ultrasound, Device: insulated needle (Contiplex B Braun, Melsungen, Germany), Drug: ropivacaineParticipants in group L will receive a single injection for femoral nerve block combined with continuous femoral nerve block intra-operatively. The femoral nerve block will be performed before the induction of anesthesia on the leg to be operated. Then the patients were given the 2% lidocaine 10 ml and 1% ropivacaine 10 ml as initial dose,then,the patients will receive a continuous infusion of 0.15% ropivacaine at 15 ml/h.Intra-operatively, bispectral index score (BIS) was titrated with the adjusting of desflurane to maintain the index between 50-60.After the surgery,these patients will receive continuous femoral nerve analgesia till 3 days post-operatively( the loading dose was set at 5 ml of 0.15% ropivacaine followed by an infusion of 0.15% ropivacaine at 5 ml/h, with bolus of 5 ml and the lock time of 30 min).
Group D	Sham comparator	Procedure: post-operative continuous femoral nerve block, Device: ultrasound, Drug: ropivacaine, Drug: salineParticipants in group D will receive the placement of femoral nerve catheter preoperatively. The same dose of 0.9% saline was injected and infused as group L intra-operatively. Bispectral index score (BIS) was titrated with the adjusting of desflurane to maintain the index between 30-40.After the surgery,these patients will receive continuous femoral nerve analgesia till 3 days post-operatively( the loading dose was set at 5 ml of 0.15% ropivacaine followed by an infusion of 0.15% ropivacaine at 5 ml/h, with bolus of 5 ml and the lock time of 30 min).

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Men and women over the 18 years and younger than 80 years old
Scheduled to receive selective unilateral knee replacement.

Key exclusion criteria (11 listed)

Bilateral knee replacement
The secondary knee revision and knee surgery not interfering with articular joint cavity (wound debridement and suture)
American Society of Anesthesiology (ASA) classification of anesthesia risk IV and V grade
Body mass index higher than 35
Coagulation dysfunction, which is assessed by activated partial thromboplastin time (APTT) higher than the upper limit by 10s; prothrombin time (PT) higher than the upper limit by 5s; International Normalized Ratio (INR) higher than 1.3, or any of criteria met above;

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
peri-operative continuous femoral nerve block with light sedationthis technique will be administered to participants in group L .The puncture site was identified using ultrasound guidance (2 cm distal to the inguinal ligament, and 1 ～2 cm lateral to the femoral artery).2% lidocaine was used for topical anesthesia, then an insulated needle (Contiplex B Braun, Melsungen, Germany) (20 G*45 mm，short bevel，30°) was connected to the nerve stimulator（Innervator，Fisher \&Paykel，New Zealand）.The parameters were as follows: stimulating intensity of 1 mA at a rate of 2 Hz. The needle was advanced at 30°～45° angle to the skin, until quadriceps femoral muscle twitches were elicited. Its position was accepted if contractions were still elicited when an output equal to 0.3 mA.The participants will receive continuous femoral nerve block intra-operatively and post-operatively till 3 days post-operatively.The depth of anesthesia will modulated at 50-60 with BIS monitoring	Procedure or surgery	Group L
post-operative continuous femoral nerve blockthis technique will be administered to participants in group D .The puncture site was identified using ultrasound guidance (2 cm distal to the inguinal ligament, and 1 ～2 cm lateral to the femoral artery).2% lidocaine was used for topical anesthesia, then an insulated needle (Contiplex B Braun, Melsungen, Germany) (20 G*45 mm，short bevel，30°) was connected to the nerve stimulator（Innervator，Fisher \&Paykel，New Zealand）.The parameters were as follows: stimulating intensity of 1 mA at a rate of 2 Hz. The needle was advanced at 30°～45° angle to the skin, until quadriceps femoral muscle twitches were elicited. Its position was accepted if contractions were still elicited when an output equal to 0.3 mA.The participants will receive continuous femoral nerve block post-operatively till 3 days post-operatively.The depth of anesthesia will modulated at 30-40 with BIS monitoring	Procedure or surgery	Group D
lidocaine	Drug	Group L
ultrasound	Device	Group D, Group L
insulated needle (Contiplex B Braun, Melsungen, Germany)	Device	Group L
ropivacaine	Drug	Group D, Group L
saline	Drug	Group D

Primary outcome

Major post-operative complications
Time frame: From the end of surgery to 30 days post-operatively
Major post-operative complications summed the incidence of major complications post-operatively( (post-operative pulmonary infection,need of mechanical respiratory support,myocardio-infarction,deep venous thrombosis, pulmonary embolism, stroke, poor wound healing,all-cause post-operative death within 30 days),participants with at least one episode of the complications will be calculated as participants with complications,both the number of participants and number of events will be calculated.

5 secondary outcomes

Acute post-operative Pain assessed by visual analogue scale
Time frame: At 12 hours ,24hours ,48hours,72 hours post-operatively
Dosages of rescue medications (mg)
Time frame: From the end of surgery to 3 days post-operatively
Dosages of intra-operative vasopressors,anesthetics and analgesics
Time frame: during the surgery
Life quality measured by euro-quality-5 dimensions (EQ-5D)
Time frame: 3 months post-operatively
Adverse events associated with the femoral catheter
Time frame: From the insertion of the catheter to 3 days post-operatively

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
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 22503334Lieberman JR, Freiberg AA, Lavernia CJ. Practice management strategies among members of the American Association of Hip and Knee Surgeons. J Arthroplasty. 2012 Sep;27(8 Suppl):17-9.e1-6. doi: 10.1016/j.arth.2012.02.030. Epub 2012 Apr 12.
Background: PubMed 23104147Wegener JT, van Ooij B, van Dijk CN, Karayeva SA, Hollmann MW, Preckel B, Stevens MF. Long-term pain and functional disability after total knee arthroplasty with and without single-injection or continuous sciatic nerve block in addition to continuous femoral nerve block: a prospective, 1-year follow-up of a randomized controlled trial. Reg Anesth Pain Med. 2013 Jan-Feb;38(1):58-63. doi: 10.1097/AAP.0b013e318272523c.
Background: PubMed 16135347Morin AM, Kratz CD, Eberhart LH, Dinges G, Heider E, Schwarz N, Eisenhardt G, Geldner G, Wulf H. Postoperative analgesia and functional recovery after total-knee replacement: comparison of a continuous posterior lumbar plexus (psoas compartment) block, a continuous femoral nerve block, and the combination of a continuous femoral and sciatic nerve block. Reg Anesth Pain Med. 2005 Sep-Oct;30(5):434-45. doi: 10.1016/j.rapm.2005.05.006.
Background: PubMed 24322572Law CJ, Jacobson GM, Kluger M, Chaddock M, Scott M, Sleigh JW. Randomized controlled trial of the effect of depth of anaesthesia on postoperative pain. Br J Anaesth. 2014 Apr;112(4):675-80. doi: 10.1093/bja/aet419. Epub 2013 Dec 8.
Background: PubMed 17976225Baldini G, Bagry H, Carli F. Depth of anesthesia with desflurane does not influence the endocrine-metabolic response to pelvic surgery. Acta Anaesthesiol Scand. 2008 Jan;52(1):99-105. doi: 10.1111/j.1399-6576.2007.01470.x. Epub 2007 Nov 1.
Background: PubMed 20679774Soumpasis I, Kanakoudis F, Vretzakis G, Arnaoutoglou E, Stamatiou G, Iatrou C. Deep anaesthesia reduces postoperative analgesic requirements after major urological procedures. Eur J Anaesthesiol. 2010 Sep;27(9):801-6. doi: 10.1097/EJA.0b013e328337cbf4.
Background: PubMed 22557763Sahni N, Anand LK, Gombar K, Gombar S. Effect of intraoperative depth of anesthesia on postoperative pain and analgesic requirement: A randomized prospective observer blinded study. J Anaesthesiol Clin Pharmacol. 2012 Apr;28(2):266-7. doi: 10.4103/0970-9185.94920. No abstract available.
Background: PubMed 22037642Whitlock EL, Villafranca AJ, Lin N, Palanca BJ, Jacobsohn E, Finkel KJ, Zhang L, Burnside BA, Kaiser HA, Evers AS, Avidan MS. Relationship between bispectral index values and volatile anesthetic concentrations during the maintenance phase of anesthesia in the B-Unaware trial. Anesthesiology. 2011 Dec;115(6):1209-18. doi: 10.1097/ALN.0b013e3182395dcb.
Background: PubMed 21293252Kertai MD, Palanca BJ, Pal N, Burnside BA, Zhang L, Sadiq F, Finkel KJ, Avidan MS; B-Unaware Study Group. Bispectral index monitoring, duration of bispectral index below 45, patient risk factors, and intermediate-term mortality after noncardiac surgery in the B-Unaware Trial. Anesthesiology. 2011 Mar;114(3):545-56. doi: 10.1097/ALN.0b013e31820c2b57.
Background: PubMed 19910621Leslie K, Myles PS, Forbes A, Chan MT. The effect of bispectral index monitoring on long-term survival in the B-aware trial. Anesth Analg. 2010 Mar 1;110(3):816-22. doi: 10.1213/ANE.0b013e3181c3bfb2. Epub 2009 Nov 12.
Background: PubMed 17943802Punjasawadwong Y, Boonjeungmonkol N, Phongchiewboon A. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003843. doi: 10.1002/14651858.CD003843.pub2.
CONsolidated Standards of Reporting Trials he Consort Group aimed at transparent reporting of the trial,"Link provided by the sponsor.

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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.

The Department of Anesthesiology,the first Affiliated Hospital of Chongqing Medical University

Chonqqing, China

86-23-89011061

plhbest@163.com

Su Min principal investigator

First Affiliated Hospital of Chongqing Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 15 Oct 2015. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major post-operative complications (time frame: From the end of surgery to 30 days post-operatively). 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 NCT02576015, which also lists 17 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 15 Oct 2015; AzTrials last refreshed its copy on 7 Nov 2026.