SPI-directed Analgesia for Lumbar Discectomy

NCT02971540 | Completed DMC

• 1 other identifier: SilesianMUKOAiIT1
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• pain perception postoperatively

  2 hours after discharge to postoperative unit.

Other Outcomes (2)

• postoperative persistent pain

  up to 6 months

• postoperative FBSS

  up to 6 months

Study Arms (5)

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

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

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

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

Drug: Metamizol; Drug: Tramadol; Drug: Bupivacaine; Drug: Ropivacaine

control group

EXPERIMENTAL

no pre-emptive analgesia will be used.

Drug: Metamizol; Drug: Tramadol; Drug: Bupivacaine; Drug: Ropivacaine; Other: control group

Interventions

Metamizol DRUG

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.

Also known as: Pyralgina

bupivacaine, LA, solution; control group; ropivacaine, LA, solution; tramadol, analgesic, solution

Tramadol DRUG

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.

Also known as: Poltram

bupivacaine, LA, solution; control group; ropivacaine, LA, solution; tramadol, analgesic, solution

Bupivacaine DRUG

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.

Also known as: Bupiwakaina WZF

control group; metamizol, analgesic, solution; ropivacaine, LA, solution; tramadol, analgesic, solution

Ropivacaine DRUG

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.

Also known as: Ropimol

bupivacaine, LA, solution; control group; metamizol, analgesic, solution; tramadol, analgesic, solution

control group OTHER

patients will receive no pre-emptive analgesia. intraoperatively standard dose of fentanyl will be used.

bupivacaine, LA, solution; control group; metamizol, analgesic, solution; ropivacaine, LA, solution

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written consent to participate in the study
• written consent to undergo general anaesthesia with local wound infiltration and surgery of discectomy

You may not qualify if:

• allergy to local anaesthetics
• necessity of administration of vasoactive drugs influencing SPI monitoring
• pregnancy

Sponsors & Collaborators

• Medical University of Silesia: lead
• Silesian University of Medicine: collaborator

Study Sites (1)

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, 41-200, Poland

Location

Related Publications (11)

• 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.

  PMID: 23471754 BACKGROUND

• Gruenewald 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.

  PMID: 24012235 BACKGROUND

• Gruenewald 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.

  PMID: 24535604 BACKGROUND

• Won 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.

  PMID: 27583920 BACKGROUND

• Cherian 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.

  PMID: 9040811 BACKGROUND

• Hernandez-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.

  PMID: 11234601 BACKGROUND

• Gurbet 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.

  PMID: 18425538 BACKGROUND

• Ozyilmaz 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.

  PMID: 22759866 BACKGROUND

• Chae 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.

  PMID: 20404955 BACKGROUND

• Yalbuzdag 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.

  PMID: 27476913 BACKGROUND

• Gruenewald 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.

  PMID: 25032676 RESULT

MeSH Terms

Conditions

Intervertebral disc disease; Early-onset ataxia with oculomotor apraxia and hypoalbuminemia

Interventions

Dipyrone; Tramadol; Bupivacaine; Ropivacaine; Control Groups

Intervention Hierarchy (Ancestors)

Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Anilides; Amides; Aniline Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Michał J Stasiowski, M.D

  Medical University of Silesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 23, 2016
• Study Start: February 1, 2016
• Primary Completion: July 30, 2017
• Study Completion: July 30, 2017
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

PL (1)