Outcomes of Intrathecal Analgesia in Colorectal Surgery

Completed

• Conditions: Surgery
• Interventions: Drug: Hydromorphone Hydrochloride

• Registration Number: NCT03411109
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-01
• Primary Completion: 2013-12-31
• Study Completion: 2013-12-31
• Status Verified: 2018-01
• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-01-19
• Last Update Submitted: 2018-01-19
• Study First Posted: 2018-01-25
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 601

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Opioid + Local Anesthetic Intrathecal	Hydromorphone Hydrochloride	-
Opioid Only Intrathecal	Hydromorphone Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Time to return of bowel function	post resection, approximately up to 48 hours	Time to return of bowel function is defined by the presence of flatus and a bowel movement

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States