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OpenTrials
Completed

NCT Number: NCT03411109

Outcomes of Intrathecal Analgesia in Colorectal Surgery

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hydromorphone hydrochloride

Drug

All intrathecal injections were performed preoperatively using a 22g or 25 g Whitacre or 24g Sprotte spinal needle. The IA regimen, medication(s) and dose(s), was at the discretion of the attending anesthesiologist, and consisted of one of the following regimens: (1) hydromorphone + local anesthetic (IA-L), or (2) hydromorphone only (IA-O). In patients receiving IA, no other interventional locoregional analgesic techniques (such as rectus sheath blocks or transversus abdominis plane blocks) were utilized.

Primary outcomes

  1. Time to return of bowel function

    Time frame: post resection, approximately up to 48 hours

    Time to return of bowel function is defined by the presence of flatus and a bowel movement

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Efficacy and Outcomes of Intrathecal Analgesia As Part of an Enhanced Recovery Pathway in Colon and Rectal Surgical Patients

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 25, 2018
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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