Outcomes of Intrathecal Analgesia in Colorectal Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411109
• Other study ID #: 13-007936
• Status: Completed
• Phase: N/A
• First received: January 19, 2018
• Last updated: January 19, 2018
• Start date: October 1, 2012
• Est. completion date: December 31, 2013

Study information

• Verified date: January 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: December 31, 2013
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Drug:
• Hydromorphone Hydrochloride
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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to return of bowel function	Time to return of bowel function is defined by the presence of flatus and a bowel movement	post resection, approximately up to 48 hours