Lumbar Disc DiseaseSPINCT02971540
SPI-directed Analgesia for Lumbar Discectomy
A study testing Metamizol, Tramadol and Bupivacaine in people with Lumbar Disc Disease, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The aim of this randomized trial is to assess the efficacy of analgesia for lumbar discectomy and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Disc Disease
- What is being tested?
- Metamizol, Tramadol and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2016to 30 Jul 2017
- 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
- written consent to participate in the study
- written consent to undergo general anaesthesia with local wound infiltration and surgery of discectomy
Who cannot join
- allergy to local anaesthetics
- necessity of administration of vasoactive drugs influencing SPI monitoring
- pregnancy
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Silesia
Sosnowiec, Silesian Voivodeship, 41-200
About this study
Official title: Comparative, Randomized Trial of SPI-directed Intravenous Analgesia Using Metamizole With Tramadol Versus Preemptive Wound Infiltration Using 0,2 % Ropivacaine With Fentanyl or 0,2 % Bupivacaine With Fentanyl for Lumbar Discectomy
The aim of this randomized trial is to assess the efficacy of analgesia for lumbar discectomy and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively.
Patients received either preemptive local tissue infiltration at surgical site using either 0,2% ropivacaine with fentanyl or 0,2% bupivacaine with fenthanyl or preemptive intravenous infusion using metamizole and tramadol.
Read the detailed description
Monitoring depth of anaesthesia using spectral entropy (SE) and quality of neuromuscular block are routine in modern anaesthesia, whereas monitoring of analgesia still requires further studies. Recently, the Surgical Pleth Index (SPI) was added as a surrogate variable showing the nociception-antinociception balance into abovementioned parametres constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia. This study aims at evaluating utility of SPI-directed analgesia in patients undergoing general anaesthesia (GA) where analgesia intraoperatively will be achieved either with regional preemptive wound infiltration using 0,2 % ropivacaine with fentanyl or 0,2 % bupivacaine with fentanyl or intravenous analgesia using continuous infusion of metamizole with tramadol for lumbar discectomy. Intraoperatively, SPI value will be recorded with sampling frequency of 1 minute. When SPI value reaches a level higher than 15 SPI points above basic level, a rescue dose of 1mg/kg body weight of fentanyl will be administered intravenously every 5 minutes until SPI value decreases to basic level calculated previously before operation started.
Additionally, the investigators will compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) values for monitoring the efficacy of analgesia postoperatively. After emergence from GA patients will be questioned in terms of their pain intensity in a scale 0-10. In the case of pain perception above 3, a bolus of 2mg of morphine will be administered intravenously every 10 minutes until pain perception will be lower than 4. SPI values will be recorded every 1 minute and analysed for aute pain (NRS 7-10), average (4-6) and mild pain perception intervals to assess if there exists a correlation between NRS and SPI.
In addition, some patients develop Failed Back Surgery Syndrome (FBSS) following lumbar surgeries so the investigators will aim to analyze if SPI-directed analgesia intra- and post-operatively reduces rate of FBSS. After 5 months after operation patient will be surveyed using melzack protocol to assess the rate of FBSS as well as symptoms of chronic pain.
- Conditions
- Lumbar Disc Disease
- Being tested
- Metamizol, Tramadol, Bupivacaine, Ropivacaine, control group
- Keywords
- Surgical Pleth Index (SPI), General Anaesthesia (GA),, Numerical Rating Scale (NRS), Adequacy of Anaesthesia (AoA, Spectral Entropy (SE), Local Anesthetic (LA)
- Medical subject headings
- Intervertebral disc disease, Early-onset ataxia with oculomotor apraxia and hypoalbuminemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetamizolDrug
Also called Pyralgina
in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram with following intravenous infusion of 5 grams per day.
TramadolDrug
Also called Poltram
in group A patients will receive pre-emptive analgesia using intravenous infusion of tramadol in a single dose of 2 mg per hg of body weight with following intravenous infusion of 400 mg per day.
BupivacaineDrug
Also called Bupiwakaina WZF
patients in group BF will receive local wound infiltration with a solution of 0,2% bupivacaine in a volume of 10 ml per segment of vertrebral columne.
RopivacaineDrug
Also called Ropimol
patients in group RF will receive local wound infiltration with a solution of 0,2% ropivacaine in a volume of 10 ml per segment of vertrebral columne.
control groupOther
patients will receive no pre-emptive analgesia. intraoperatively standard dose of fentanyl will be used.
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine, LA, solution | Experimental | an a local anesthetic administered for local wound infiltration on each side in a single dose of 10 ml of 0,2% solution per segment of vertrebral columne with potential duration time of up to 8 hours according to manufacturers data Receives: Drug: Metamizol; Drug: Tramadol; Drug: Ropivacaine; Other: control group |
| ropivacaine, LA, solution | Experimental | an a local anesthetic administered for local wound infiltration on each side in a single dose of 10 ml of 0,2% solution per segment of vertrebral columne with potential duration time of up to 8 hours according to manufacturers data Receives: Drug: Metamizol; Drug: Tramadol; Drug: Bupivacaine; Other: control group |
| metamizol, analgesic, solution | Experimental | an analgesic drug administered intravenously for pre-emptive analgesia in a initial dose of 1-1,25g with potential duration time of up to 6 hours according to manufacturers data Receives: Drug: Bupivacaine; Drug: Ropivacaine; Other: control group |
| tramadol, analgesic, solution | Experimental | a half-opioid drug administered intravenously for pre-emptive analgesia in a initial dose of 2 mg per kg of body weight with potential duration time of up to 6 hours according to manufacturers data Receives: Drug: Metamizol; Drug: Tramadol; Drug: Bupivacaine; Drug: Ropivacaine |
| control group | Experimental | no pre-emptive analgesia will be used. Receives: Drug: Metamizol; Drug: Tramadol; Drug: Bupivacaine; Drug: Ropivacaine; Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain perception intraoperatively
The investigators will compare the efficacy of analgesia intraoperatively according to technique of analgesia used preoperatively: either local woung inflitration or intravenous infusion. The investigators will administer a resuce dose of fentanyl intravenously in a dose of 1 mcg per kg of body weight in the case when SPI value increases over 15 points in SPI scale every 5 minutes untill SPI value decreases back to baseline value
Measured: on-line based on SPI values
Secondary outcomes (1)
pain perception postoperatively
The investigators will compare the efficacy of analgesia postoperatively according to technique of analgesia used preoperatively: either local woung inflitration or intravenous infusion. The investigators use NRS and compare it with SPI values. Additionally, The investigators will observe SPI variations as a reaction to morphine administration intravenously in the case of acute or moderate pain.
Measured: 2 hours after discharge to postoperative unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startFeb 2016
- Primary completion30 Jul 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc DiseaseStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Collaborators
- Silesian University of Medicine
- Responsible party
- Principal investigator, Michał Stasiowski, Medical University of Silesia
- Investigators
- Michał J Stasiowski, M.D, Principal investigator, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971540
- Sponsor's protocol ID
- SilesianMUKOAiIT1
- Acronym
- SPI
- Status last verified
- Apr 2019
- First submitted
- 2 Nov 2016
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: article in AiIT in 2019,
Publications
Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.
PubMed 23471754Gruenewald M, Ilies C. Monitoring the nociception-anti-nociception balance. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):235-47. doi: 10.1016/j.bpa.2013.06.007.
PubMed 24012235Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10.1093/bja/aet485. Epub 2014 Feb 16.
PubMed 24535604Won YJ, Lim BG, Lee SH, Park S, Kim H, Lee IO, Kong MH. Comparison of relative oxycodone consumption in surgical pleth index-guided analgesia versus conventional analgesia during sevoflurane anesthesia: A randomized controlled trial. Medicine (Baltimore). 2016 Aug;95(35):e4743. doi: 10.1097/MD.0000000000004743.
PubMed 27583920Cherian MN, Mathews MP, Chandy MJ. Local wound infiltration with bupivacaine in lumbar laminectomy. Surg Neurol. 1997 Feb;47(2):120-2; discussion 122-3. doi: 10.1016/s0090-3019(96)00255-8.
PubMed 9040811Hernandez-Palazon J, Tortosa Serrano JA, Burguillos Lopez S, Molero Molero E. [Infiltration of the surgical wound with local anesthetic for postoperative analgesia in patients operated on for lumbar disc herniation. Comparative study of ropivacaine and bupivacaine]. Rev Esp Anestesiol Reanim. 2001 Jan;48(1):17-20. Spanish.
PubMed 11234601Gurbet A, Bekar A, Bilgin H, Korfali G, Yilmazlar S, Tercan M. Pre-emptive infiltration of levobupivacaine is superior to at-closure administration in lumbar laminectomy patients. Eur Spine J. 2008 Sep;17(9):1237-41. doi: 10.1007/s00586-008-0676-z. Epub 2008 Apr 19.
PubMed 18425538Ozyilmaz K, Ayoglu H, Okyay RD, Yurtlu S, Koksal B, Hanci V, Erdogan G, Turan IO. Postoperative analgesic effects of wound infiltration with tramadol and levobupivacaine in lumbar disk surgeries. J Neurosurg Anesthesiol. 2012 Oct;24(4):331-5. doi: 10.1097/ANA.0b013e3182611a1d.
PubMed 22759866Chae SU, Kim TK, Shim DM, Kim YJ, Choi DH. Is complex regional pain syndrome a cause of post-operative syndrome in the lumbar spine? - a case report -. Asian Spine J. 2009 Dec;3(2):101-5. doi: 10.4184/asj.2009.3.2.101. Epub 2009 Dec 31.
PubMed 20404955Yalbuzdag SA, Erol AM, Sengul I, Celik C, Solum S, Adilay HU, Gungor B. Temperament and Character Profile in Failed Back Surgery Syndrome: A Cross-Sectional Clinical Study. Turk Neurosurg. 2016;26(6):912-917. doi: 10.5137/1019-5149.JTN.13679-14.0.
PubMed 27476913Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 Jul 17.
PubMed 25032676
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Randomized Trial of SPI-directed Intravenous Analgesia Using Metamizole With Tramadol Versus Preemptive Wound Infiltration Using 0,2 % Ropivacaine With Fentanyl or 0,2 % Bupivacaine With Fentanyl for Lumbar Discectomy
- ClinicalTrials.gov ID
- NCT02971540
- Acronym / sponsor ID
- SPI / SilesianMUKOAiIT1
- Conditions
- Lumbar Disc Disease
- Keywords
- Surgical Pleth Index (SPI), General Anaesthesia (GA),, Numerical Rating Scale (NRS), Adequacy of Anaesthesia (AoA, Spectral Entropy (SE), Local Anesthetic (LA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- Silesian University of Medicine
- Study start
- Feb 2016
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 23 Nov 2016 (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.
The aim of this randomized trial is to assess the efficacy of analgesia for lumbar discectomy and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively.
Patients received either preemptive local tissue infiltration at surgical site using either 0,2% ropivacaine with fentanyl or 0,2% bupivacaine with fenthanyl or preemptive intravenous infusion using metamizole and tramadol.
Detailed description
Monitoring depth of anaesthesia using spectral entropy (SE) and quality of neuromuscular block are routine in modern anaesthesia, whereas monitoring of analgesia still requires further studies. Recently, the Surgical Pleth Index (SPI) was added as a surrogate variable showing the nociception-antinociception balance into abovementioned parametres constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia. This study aims at evaluating utility of SPI-directed analgesia in patients undergoing general anaesthesia (GA) where analgesia intraoperatively will be achieved either with regional preemptive wound infiltration using 0,2 % ropivacaine with fentanyl or 0,2 % bupivacaine with fentanyl or intravenous analgesia using continuous infusion of metamizole with tramadol for lumbar discectomy. Intraoperatively, SPI value will be recorded with sampling frequency of 1 minute. When SPI value reaches a level higher than 15 SPI points above basic level, a rescue dose of 1mg/kg body weight of fentanyl will be administered intravenously every 5 minutes until SPI value decreases to basic level calculated previously before operation started.
Additionally, the investigators will compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) values for monitoring the efficacy of analgesia postoperatively. After emergence from GA patients will be questioned in terms of their pain intensity in a scale 0-10. In the case of pain perception above 3, a bolus of 2mg of morphine will be administered intravenously every 10 minutes until pain perception will be lower than 4. SPI values will be recorded every 1 minute and analysed for aute pain (NRS 7-10), average (4-6) and mild pain perception intervals to assess if there exists a correlation between NRS and SPI.
In addition, some patients develop Failed Back Surgery Syndrome (FBSS) following lumbar surgeries so the investigators will aim to analyze if SPI-directed analgesia intra- and post-operatively reduces rate of FBSS. After 5 months after operation patient will be surveyed using melzack protocol to assess the rate of FBSS as well as symptoms of chronic pain.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| bupivacaine, LA, solution | Experimental | Drug: Metamizol, Drug: Tramadol, Drug: Ropivacaine, Other: control groupan a local anesthetic administered for local wound infiltration on each side in a single dose of 10 ml of 0,2% solution per segment of vertrebral columne with potential duration time of up to 8 hours according to manufacturers data |
| ropivacaine, LA, solution | Experimental | Drug: Metamizol, Drug: Tramadol, Drug: Bupivacaine, Other: control groupan a local anesthetic administered for local wound infiltration on each side in a single dose of 10 ml of 0,2% solution per segment of vertrebral columne with potential duration time of up to 8 hours according to manufacturers data |
| metamizol, analgesic, solution | Experimental | Drug: Bupivacaine, Drug: Ropivacaine, Other: control groupan analgesic drug administered intravenously for pre-emptive analgesia in a initial dose of 1-1,25g with potential duration time of up to 6 hours according to manufacturers data |
| tramadol, analgesic, solution | Experimental | Drug: Metamizol, Drug: Tramadol, Drug: Bupivacaine, Drug: Ropivacainea half-opioid drug administered intravenously for pre-emptive analgesia in a initial dose of 2 mg per kg of body weight with potential duration time of up to 6 hours according to manufacturers data |
| control group | Experimental | Drug: Metamizol, Drug: Tramadol, Drug: Bupivacaine, Drug: Ropivacaine, Other: control groupno pre-emptive analgesia will be used. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- written consent to participate in the study
- written consent to undergo general anaesthesia with local wound infiltration and surgery of discectomy
Key exclusion criteria (3 listed)
- allergy to local anaesthetics
- necessity of administration of vasoactive drugs influencing SPI monitoring
- pregnancy
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 |
|---|---|---|
| MetamizolAlso: Pyralginain group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram with following intravenous infusion of 5 grams per day. | Drug | bupivacaine, LA, solution, control group, ropivacaine, LA, solution, tramadol, analgesic, solution |
| TramadolAlso: Poltramin group A patients will receive pre-emptive analgesia using intravenous infusion of tramadol in a single dose of 2 mg per hg of body weight with following intravenous infusion of 400 mg per day. | Drug | bupivacaine, LA, solution, control group, ropivacaine, LA, solution, tramadol, analgesic, solution |
| BupivacaineAlso: Bupiwakaina WZFpatients in group BF will receive local wound infiltration with a solution of 0,2% bupivacaine in a volume of 10 ml per segment of vertrebral columne. | Drug | control group, metamizol, analgesic, solution, ropivacaine, LA, solution, tramadol, analgesic, solution |
| RopivacaineAlso: Ropimolpatients in group RF will receive local wound infiltration with a solution of 0,2% ropivacaine in a volume of 10 ml per segment of vertrebral columne. | Drug | bupivacaine, LA, solution, control group, metamizol, analgesic, solution, tramadol, analgesic, solution |
| control grouppatients will receive no pre-emptive analgesia. intraoperatively standard dose of fentanyl will be used. | Other | bupivacaine, LA, solution, control group, metamizol, analgesic, solution, ropivacaine, LA, solution |
Primary outcome
pain perception intraoperatively
Time frame: on-line based on SPI values
The investigators will compare the efficacy of analgesia intraoperatively according to technique of analgesia used preoperatively: either local woung inflitration or intravenous infusion. The investigators will administer a resuce dose of fentanyl intravenously in a dose of 1 mcg per kg of body weight in the case when SPI value increases over 15 points in SPI scale every 5 minutes untill SPI value decreases back to baseline value
1 secondary outcome
pain perception postoperatively
Time frame: 2 hours after discharge to postoperative unit.
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 16 Apr 2019.
- Background: PubMed 23471754Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.
- Background: PubMed 24012235Gruenewald M, Ilies C. Monitoring the nociception-anti-nociception balance. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):235-47. doi: 10.1016/j.bpa.2013.06.007.
- Background: PubMed 24535604Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10.1093/bja/aet485. Epub 2014 Feb 16.
- Background: PubMed 27583920Won YJ, Lim BG, Lee SH, Park S, Kim H, Lee IO, Kong MH. Comparison of relative oxycodone consumption in surgical pleth index-guided analgesia versus conventional analgesia during sevoflurane anesthesia: A randomized controlled trial. Medicine (Baltimore). 2016 Aug;95(35):e4743. doi: 10.1097/MD.0000000000004743.
- Background: PubMed 9040811Cherian MN, Mathews MP, Chandy MJ. Local wound infiltration with bupivacaine in lumbar laminectomy. Surg Neurol. 1997 Feb;47(2):120-2; discussion 122-3. doi: 10.1016/s0090-3019(96)00255-8.
- Background: PubMed 11234601Hernandez-Palazon J, Tortosa Serrano JA, Burguillos Lopez S, Molero Molero E. [Infiltration of the surgical wound with local anesthetic for postoperative analgesia in patients operated on for lumbar disc herniation. Comparative study of ropivacaine and bupivacaine]. Rev Esp Anestesiol Reanim. 2001 Jan;48(1):17-20. Spanish.
- Background: PubMed 18425538Gurbet A, Bekar A, Bilgin H, Korfali G, Yilmazlar S, Tercan M. Pre-emptive infiltration of levobupivacaine is superior to at-closure administration in lumbar laminectomy patients. Eur Spine J. 2008 Sep;17(9):1237-41. doi: 10.1007/s00586-008-0676-z. Epub 2008 Apr 19.
- Background: PubMed 22759866Ozyilmaz K, Ayoglu H, Okyay RD, Yurtlu S, Koksal B, Hanci V, Erdogan G, Turan IO. Postoperative analgesic effects of wound infiltration with tramadol and levobupivacaine in lumbar disk surgeries. J Neurosurg Anesthesiol. 2012 Oct;24(4):331-5. doi: 10.1097/ANA.0b013e3182611a1d.
- Background: PubMed 20404955Chae SU, Kim TK, Shim DM, Kim YJ, Choi DH. Is complex regional pain syndrome a cause of post-operative syndrome in the lumbar spine? - a case report -. Asian Spine J. 2009 Dec;3(2):101-5. doi: 10.4184/asj.2009.3.2.101. Epub 2009 Dec 31.
- Background: PubMed 27476913Yalbuzdag SA, Erol AM, Sengul I, Celik C, Solum S, Adilay HU, Gungor B. Temperament and Character Profile in Failed Back Surgery Syndrome: A Cross-Sectional Clinical Study. Turk Neurosurg. 2016;26(6):912-917. doi: 10.5137/1019-5149.JTN.13679-14.0.
- Results publication: PubMed 25032676Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 Jul 17.
- Individual participant dataSharing planned: Yes. article in AiIT in 2019,
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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.
Michał J Stasiowski, M.D principal investigator
Medical University of Silesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metamizol, Tramadol and Bupivacaine in people with Lumbar Disc Disease, run by Medical University of Silesia at 1 site in Poland.
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 3 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 16 Apr 2019. 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 Poland. 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. 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?
pain perception intraoperatively (time frame: on-line based on SPI values). 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 NCT02971540, which also lists 11 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 16 Apr 2019.