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Outcomes of Intrathecal Analgesia in Colorectal Surgery

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Mayo Clinic

Status

Completed

Conditions

Surgery

Treatments

Drug: Hydromorphone Hydrochloride

Study type

Observational

Funder types

Other

Identifiers

NCT03411109
13-007936

Details and patient eligibility

About

Multimodal analgesia, sometimes including intrathecal analgesia (IA), is essential in any enhanced recovery pathway (ERP). This study aimed to evaluate the safety, feasibility, and optimal IA regimen in colorectal surgical patients.

Enrollment

601 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All adult colorectal patients from October 2012 through December 2013 in which patients received single-injection IA as part of a multimodal analgesic strategy for ERP.
  • Undergoing an elective colorectal operation (minimally invasive or open)

Exclusion criteria

  • Patients aged < 18 years
  • American Society of Anesthesiologists (ASA) 5 and 6 classification
  • pregnancy
  • failure to provide research authorization.
  • emergent operations

Trial design

601 participants in 2 patient groups

Opioid Only Intrathecal
Treatment:
Drug: Hydromorphone Hydrochloride
Opioid + Local Anesthetic Intrathecal
Treatment:
Drug: Hydromorphone Hydrochloride

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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