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

NCT02813382 | Completed DMC

• 1 other identifier: Spinal-001
• Study Type: observational
• Target: 101
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia, Spinal; Ambulatory Surgical Procedures; Hernia, Inguinal; Hernia, Umbilical

Keywords

bupivacaine; prilocaine; 2-chloroprocaine

Outcome Measures

Primary Outcomes (1)

• Time to void

  Postoperative spontaneous voiding (\>200ml).

  up to 24hours after surgery

Secondary Outcomes (7)

• in hospital time

  up to 24hours after surgery

• time from spinal anesthesia to ready-to-cut

  an average of 3 minutes

• time from spinal anesthesia to start of surgery

  an average of 3 minutes

• time to T6

  1 hour

• time to T10

  1 hour

Study Arms (3)

B-group

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

Drug: Bupivacaine

C-group

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

Drug: Chloroprocaine

P-group

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

Drug: Prilocaine

Interventions

Bupivacaine DRUG

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

B-group

Prilocaine DRUG

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

P-group

Chloroprocaine DRUG

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

Also known as: 2-chloroprocaine

C-group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AZ St.-Dimpna Geel: lead

Related Publications (5)

• 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.

  PMID: 23320599 RESULT

• 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.

  PMID: 21203878 RESULT

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

  PMID: 25211156 RESULT

• 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.

  PMID: 20529983 RESULT

• 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.

  PMID: 23176984 RESULT

MeSH Terms

Conditions

Hernia, Inguinal; Hernia, Umbilical

Interventions

Bupivacaine; Prilocaine; chloroprocaine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ben Gys, md

  AZ Sint Dimpna, Geel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: md

Study Record Dates

• First Submitted: June 19, 2016
• First Posted: June 27, 2016
• Study Start: August 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 28, 2016

Record last verified: 2016-06