AzTrials
AzTrials

Anesthesia, SpinalspinalNCT02813382

Spinal Anesthesia for Outpatient Abdominal Wall Surgery: Comparison of Bupivacaine, 2-chloroprocaine and Prilocaine

An observational study of Anesthesia, Spinal and Ambulatory Surgical Procedures, run by AZ St.-Dimpna Geel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Considering fast-track principles, an ideal spinal anesthetic should have minimal complications and above all fast recovery so reducing in-hospital stay. Between 1/8/2015 and 1/1/2016, a total of 101 patients attending the surgeon's practice with an umbilical or unilateral inguinal hernia and no contra-indications for… Read more about this study

Who is it for?
Any age
What is being tested?
Bupivacaine, Prilocaine and Chloroprocaine
How many people
101 participants
Where
No sites listed yet
Study dates
Aug 2015to Feb 2016
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 105 consecutive patients undergoing elective unilateral open inguinal or umbilical hernia repair.

Who may be able to join

  • unilateral open inguinal or umbilical hernia repair
  • capable to understand the risks and commitment associated with the surgery and anesthesia

Who cannot join

  • concomittant surgical of non-surgical procedure
  • no agreement to informed consent

About this study

Official title: Intrathecal 60mg Prilocaine, Hyperbaric 40mg 9-chloroprocaine and 10.5mg Bupivacaine Each With Added Sufentanil (2µg) for Elective Ambulatory Umbilical and Unilateral Inguinal Herniorrhaphy

Considering fast-track principles, an ideal spinal anesthetic should have minimal complications and above all fast recovery so reducing in-hospital stay.

Between 1/8/2015 and 1/1/2016, a total of 101 patients attending the surgeon's practice with an umbilical or unilateral inguinal hernia and no contra-indications for surgery were included in this study. Patients were given 10.5mg bupivacaine (B-group), 40mg hyperbaric 2-chloroprocaïne (C-group) or 60mg prilocaïne (P-group), each with added sufentanil (2µg). Motor block was assessed using the Bromage scale. Sensory block was measured by determining the peak level dermatome. Intraoperative hemodynamic parameters were listed. Resolution of sensory and motor block, time to void and home readiness were defined as clinical endpoints.

Read the detailed description

Open inguinal and umbilical hernia repair are two of the most performed interventions in day-care surgery. Fast-track surgery implies a swift and effective form of anesthesia which is easy to carry out, has few side-effects and is quickly reversed.

Spinal anesthesia has proven to be a safe method to ensure adequate analgesia for patients undergoing elective open abdominal wall surgery as the need and side-effects of general anesthesia are avoided. During many years, a variety of intrathecal products alongside a plethora of adjuvants have been evaluated.

Three different types of spinal anesthetic products already used in routine care were compared: hyperbaric 9-chloroprocaïne (Ampres®, Nordic Pharma), bupivacaine (Marcaine®, AstraZeneca) and prilocaine (Tachipri®, Nordic Pharma).

Between 1/8/2015 and 1/1/2016, a total of 101 patients attending the surgeon's practice with an umbilical or unilateral inguinal hernia and no contra-indications for surgery were included in this study. Local ethical committee approval (EC0G099 - AZ Sint Dimpna, Geel, Belgium) and individual written informed consent was obtained. Surgical procedures were performed by 2 surgeons (TL and TG). The hernia was diagnosed clinically and/or by ultrasonography. Patients were preoperatively informed about the details concerning surgery and anesthesiology.

All patients were hospitalized on the day of surgery following standard preoperative instructions. Spinal anesthesia was performed by 6 different anesthesiologists. Patients with contraindications for spinal anesthesia were excluded: INR (international normalized ratio) > 1.2, thrombocytopenia (<75.000/µl), symptomatic neurological disease and proven allergy for local anesthetic. All patients received 1g of cefazolin (following standard guidelines for antibiotic prophylaxis of surgical wounds).

Patient's baseline features were listed: gender, age, Body Mass Index (BMI), Anesthesiologists Physical Status classification (ASA classification), their position at the moment of intrathecal infusion (sitting up or lateral decubitus) and type and length of surgery. Open inguinal herniorrhaphy was performed following the Liechtenstein technique as described by Chastan. For the treatment of an umbilical hernia, a polypropylene-ePTFE hernia patch (Ventralex™, BARD®) was used .

Patients were given 10.5mg bupivacaine (B-group), 40.0mg of hyperbaric 2-chloroprocaïne (C-group) or 60.0mg prilocaïne (P-group), each in combination with sufentanil (2.0µg).

All patients with pre-existing hypotension (<120/80) were administered 5.0mg of ephedrine and 0.2mg of glycopyrroniumbromide IV upon entering the operation theater through a standard peripheral catheter. Regular monitoring was used during the procedure: electronic blood pressure monitoring, pulse oximetry and 3-lead electrocardiogram. Hemodynamic anomalies were listed: hypotension (systolic pressure <75% of baseline value), bradycardia (pulse <60/min) and desaturation (<92% without oxygen).

Under sterile conditions, local anesthesia of the skin of the lower back was performed (using 1% 3cc lidocaine). Afterwards, puncture of the arachnoid mater (using a 25G Sprottle Needle) was performed at the L2-L3 interspace and the predetermined product instilled. This procedure was performed sitting-up or in dorsolateral decubitus (in inguinal hernia repair lying on the ipsilateral side when using prilocaine or bupivacaine and on the contralateral side when using hyperbaric 2-chloroprocaine). Patients who received their spinal block in the sitting up position were instantly put in the dorsolateral position after the injection (side again depending on the product and type of surgery as described above). Regardless of these proceedings, all patients receiving 9-chloroprocaine were put in the reverse Trendelenburg position (approximately 20°) for 2 minutes immediately after infusion.

After injection, sensory and motor block assessment was performed and listed on predetermined moments: 1, 3, 30 minutes after infusion and from then on every 15 minutes until spontaneous voiding (>200ml) was achieved. Sensory block was evaluated from toe to head at the surgical side using the loss of sensation to cold fluids (ether). Motor block was assessed using the Bromage scale.

During surgery, hypotension (systolic pressure <75% of baseline value) was treated with ephedrine and bradycardia with atropine or ephedrine. Patients who suffered from desaturation (blood oxygen saturation <92%) received oxygen through a standard face mask starting at 2l/min. Fentanyl 25 to 100µg was given when pain was felt by the patient. If insufficient analgesia was achieved (insufficient sensory block), general anesthesia was initiated. Intraoperative IV analgesia consisted of standard postoperative pain medication (taradyl and perfusalgan). If there was a history of duodenal ulcus, kidney insufficiency and/or intolerance for NSAIDs, taradyl was replaced with dynastat.

Postoperatively, all patients were transferred to the Post-Anesthesia Care Unit (PACU), where they received standard postoperative analgesia (paracetamol 1g IV and/or taradyl 30mg IV). If insufficient, fentanyl was administered. Postoperative nausea and vomiting (PONV) was treated with alizapride and ondansetron. After a minimum stay of 90 minutes, signs of regression of the motor block (Bromage scale) and normal hemodynamic parameters, patients were transferred to the day-care hospital for further recovery.

Resolution of sensory and motor blockage, time to void and home readiness (spontaneous voiding, ability to walk without assistance, the absence of nausea or vomiting and stable hemodynamic parameters) were defined as clinical endpoints. Pain experienced at the day-care hospital was managed with oral paracetamol (500mg) and/or ibuprofen (600mg), after determination of a Visual Analog Scale for Pain (VAS).

All data was analyzed using IBM SPSS statistical software version 23 and Microsoft Excel 2010. Comparison of continuous variables was performed using the F-test and posthoc analysis . Categorical variables were compared by means of a chi-square test. A P-value < 0.05 was considered statistically significant.

Being tested
Bupivacaine, Prilocaine, Chloroprocaine
Keywords
bupivacaine, prilocaine, 2-chloroprocaine
Medical subject headings
Hernia, Inguinal, Hernia, Umbilical

What participants receive

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

  • BupivacaineDrug

    Spinal anesthesia was performed using 10.5mg bupivacaine with added sufentanil (2µg).

  • PrilocaineDrug

    Spinal anesthesia was performed using 60mg prilocaïne with added sufentanil (2µg).

  • ChloroprocaineDrug

    Also called 2-chloroprocaine

    Spinal anesthesia was performed using 40mg hyperbaric 2-chloroprocaïne with added sufentanil (2µg).

Study groups in NCT02813382
Study groupRoleWhat they receive
B-groupSpinal anesthesia was performed using 10.5mg bupivacaine with added sufentanil (2µg).
Receives: Drug: Bupivacaine
C-groupSpinal anesthesia was performed using 40mg hyperbaric 2-chloroprocaïne with added sufentanil (2µg).
Receives: Drug: Chloroprocaine
P-groupSpinal anesthesia was performed using 60mg prilocaïne with added sufentanil (2µg).
Receives: Drug: Prilocaine

What is being measured

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

  1. Time to void

    Postoperative spontaneous voiding (>200ml).

    Measured: up to 24hours after surgery

Secondary outcomes (7)
  1. in hospital time

    Measured: up to 24hours after surgery

  2. time from spinal anesthesia to ready-to-cut

    Measured: an average of 3 minutes

  3. time from spinal anesthesia to start of surgery

    Measured: an average of 3 minutes

  4. time to T6

    Time to reach sensory block at the T6 dermatome after intrathecal infusion.

    Measured: 1 hour

  5. time to T10

    Time to reach sensory block at the T10 dermatome after intrathecal infusion.

    Measured: 1 hour

  6. time to onset of peak sensory level block

    Measured: an average of 60 minutes

  7. peak sensory level (dermatome)

    Peak sensory block height (according to dermatomes).

    Measured: an average of 60 minutes

Timeline

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

  1. First posted27 Jun 2016 (estimated)
  2. Study startAug 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02813382
Sponsor's protocol ID
Spinal-001
Acronym
spinal
Status last verified
Jun 2016
First submitted
19 Jun 2016
Last updated
28 Jun 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Goldblum E, Atchabahian A. The use of 2-chloroprocaine for spinal anaesthesia. Acta Anaesthesiol Scand. 2013 May;57(5):545-52. doi: 10.1111/aas.12071. Epub 2013 Jan 16.

    PubMed 23320599
  • Lacasse MA, Roy JD, Forget J, Vandenbroucke F, Seal RF, Beaulieu D, McCormack M, Massicotte L. Comparison of bupivacaine and 2-chloroprocaine for spinal anesthesia for outpatient surgery: a double-blind randomized trial. Can J Anaesth. 2011 Apr;58(4):384-91. doi: 10.1007/s12630-010-9450-x. Epub 2011 Jan 4.

    PubMed 21203878
  • Forster JG. Short-acting spinal anesthesia in the ambulatory setting. Curr Opin Anaesthesiol. 2014 Dec;27(6):597-604. doi: 10.1097/ACO.0000000000000126.

    PubMed 25211156
  • Camponovo C, Fanelli A, Ghisi D, Cristina D, Fanelli G. A prospective, double-blinded, randomized, clinical trial comparing the efficacy of 40 mg and 60 mg hyperbaric 2% prilocaine versus 60 mg plain 2% prilocaine for intrathecal anesthesia in ambulatory surgery. Anesth Analg. 2010 Aug;111(2):568-72. doi: 10.1213/ANE.0b013e3181e30bb8. Epub 2010 Jun 7.

    PubMed 20529983
  • Akcaboy ZN, Akcaboy EY, Mutlu NM, Serger N, Aksu C, Gogus N. Spinal anesthesia with low-dose bupivacaine-fentanyl combination: a good alternative for day case transurethral resection of prostrate surgery in geriatric patients. Rev Bras Anestesiol. 2012 Nov-Dec;62(6):753-61. doi: 10.1016/S0034-7094(12)70176-9.

    PubMed 23176984

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, Spinal and Ambulatory Surgical Procedures, run by AZ St.-Dimpna Geel.

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 2 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 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Time to void (time frame: up to 24hours 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 NCT02813382, which also lists 5 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 28 Jun 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in