Outcomes of Intrathecal Analgesia in Colorectal Surgery

NCT03411109 | Completed DMC FDA Drug

• 1 other identifier: 13-007936
• Study Type: observational
• Target: 601
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgery

Keywords

intrathecal analgesia; colorectal; enhanced recovery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Opioid Only Intrathecal

Drug: Hydromorphone Hydrochloride

Opioid + Local Anesthetic Intrathecal

Drug: Hydromorphone Hydrochloride

Interventions

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.

Opioid + Local Anesthetic Intrathecal; Opioid Only Intrathecal

Eligibility Criteria

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

Study Population

All adult patients receiving colorectal surgical care at a tertiary care, academic institution.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Merchea A, Lovely JK, Jacob AK, Colibaseanu DT, Kelley SR, Mathis KL, Spears GM, Huebner M, Larson DW. Efficacy and Outcomes of Intrathecal Analgesia as Part of an Enhanced Recovery Pathway in Colon and Rectal Surgical Patients. Surg Res Pract. 2018 Mar 1;2018:8174579. doi: 10.1155/2018/8174579. eCollection 2018.

  PMID: 29687077 DERIVED

MeSH Terms

Interventions

Hydromorphone

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Adam Jacob, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 25, 2018
• Study Start: October 1, 2012
• Primary Completion: December 31, 2013
• Study Completion: December 31, 2013
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)