SPI-directed Analgesia for Lumbar Discectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lumbar Disc Disease

Intervention / Treatment
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* Drug: Metamizol
* Drug: Tramadol
* Drug: Bupivacaine
* Drug: Ropivacaine
* Other: control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written consent to participate in the study written consent to undergo general anaesthesia with local wound infiltration and surgery of discectomy Exclusion Criteria: allergy to local anaesthetics necessity of administration of vasoactive drugs influencing SPI monitoring pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bupivacaine, LA, solution<br>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 | Drug: Metamizol<br>* 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.<br>* Other names: Pyralgina;Drug: Tramadol<br>* 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.<br>* Other names: Poltram;Drug: Ropivacaine<br>* 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.<br>* Other names: Ropimol;Other: control group<br>* patients will receive no pre-emptive analgesia. intraoperatively standard dose of fentanyl will be used.<br>|
| Experimental: ropivacaine, LA, solution<br>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 | Drug: Metamizol<br>* 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.<br>* Other names: Pyralgina;Drug: Tramadol<br>* 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.<br>* Other names: Poltram;Drug: Bupivacaine<br>* 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.<br>* Other names: Bupiwakaina WZF;Other: control group<br>* patients will receive no pre-emptive analgesia. intraoperatively standard dose of fentanyl will be used.<br>|
| Experimental: metamizol, analgesic, solution<br>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 | Drug: Bupivacaine<br>* 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.<br>* Other names: Bupiwakaina WZF;Drug: Ropivacaine<br>* 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.<br>* Other names: Ropimol;Other: control group<br>* patients will receive no pre-emptive analgesia. intraoperatively standard dose of fentanyl will be used.<br>|
| Experimental: tramadol, analgesic, solution<br>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 | Drug: Metamizol<br>* 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.<br>* Other names: Pyralgina;Drug: Tramadol<br>* 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.<br>* Other names: Poltram;Drug: Bupivacaine<br>* 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.<br>* Other names: Bupiwakaina WZF;Drug: Ropivacaine<br>* 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.<br>* Other names: Ropimol;|
| Experimental: control group<br>no pre-emptive analgesia will be used. | Drug: Metamizol<br>* 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.<br>* Other names: Pyralgina;Drug: Tramadol<br>* 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.<br>* Other names: Poltram;Drug: Bupivacaine<br>* 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.<br>* Other names: Bupiwakaina WZF;Drug: Ropivacaine<br>* 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.<br>* Other names: Ropimol;Other: control group<br>* patients will receive no pre-emptive analgesia. intraoperatively standard dose of fentanyl will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | on-line based on SPI values | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 hours after discharge to postoperative unit. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Pleth Index (SPI), General Anaesthesia (GA),, Numerical Rating Scale (NRS), Adequacy of Anaesthesia (AoA, Spectral Entropy (SE), Local Anesthetic (LA)