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

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ClinicalTrials.gov Identifier: NCT02813382
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
Ben Gys, AZ St.-Dimpna Geel

Brief 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 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.


Condition or disease Intervention/treatment
Anesthesia, Spinal Ambulatory Surgical Procedures Hernia, Inguinal Hernia, Umbilical Drug: Bupivacaine Drug: Prilocaine Drug: Chloroprocaine

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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : August 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016


Group/Cohort Intervention/treatment
B-group
Spinal anesthesia was performed using 10.5mg bupivacaine with added sufentanil (2µg).
Drug: Bupivacaine
Spinal anesthesia was performed using 10.5mg bupivacaine with added sufentanil (2µg).

C-group
Spinal anesthesia was performed using 40mg hyperbaric 2-chloroprocaïne with added sufentanil (2µg).
Drug: Chloroprocaine
Spinal anesthesia was performed using 40mg hyperbaric 2-chloroprocaïne with added sufentanil (2µg).
Other Name: 2-chloroprocaine

P-group
Spinal anesthesia was performed using 60mg prilocaïne with added sufentanil (2µg).
Drug: Prilocaine
Spinal anesthesia was performed using 60mg prilocaïne with added sufentanil (2µg).




Primary Outcome Measures :
  1. Time to void [ Time Frame: up to 24hours after surgery ]
    Postoperative spontaneous voiding (>200ml).


Secondary Outcome Measures :
  1. in hospital time [ Time Frame: up to 24hours after surgery ]
  2. time from spinal anesthesia to ready-to-cut [ Time Frame: an average of 3 minutes ]
  3. time from spinal anesthesia to start of surgery [ Time Frame: an average of 3 minutes ]
  4. time to T6 [ Time Frame: 1 hour ]
    Time to reach sensory block at the T6 dermatome after intrathecal infusion.

  5. time to T10 [ Time Frame: 1 hour ]
    Time to reach sensory block at the T10 dermatome after intrathecal infusion.

  6. time to onset of peak sensory level block [ Time Frame: an average of 60 minutes ]
  7. peak sensory level (dermatome) [ Time Frame: an average of 60 minutes ]
    Peak sensory block height (according to dermatomes).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
105 consecutive patients undergoing elective unilateral open inguinal or umbilical hernia repair.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813382


Sponsors and Collaborators
AZ St.-Dimpna Geel
Investigators
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Principal Investigator: Ben Gys, md AZ Sint Dimpna, Geel
Publications of Results:
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Responsible Party: Ben Gys, md, AZ St.-Dimpna Geel
ClinicalTrials.gov Identifier: NCT02813382    
Other Study ID Numbers: Spinal-001
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ben Gys, AZ St.-Dimpna Geel:
bupivacaine
prilocaine
2-chloroprocaine
Additional relevant MeSH terms:
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Hernia, Umbilical
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Infant, Newborn, Diseases
Hernia, Ventral
Bupivacaine
Prilocaine
Chloroprocaine
Procaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents