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NCT03817034 Clinical Trial

Multimodal Analgesia for the Reduction of Postoperative Opioid Consumption

Pain Clinical Trial

Official title:
Multimodal Analgesia for the Reduction of Postoperative Opioid Consumption

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03817034
Other study ID # 2018P002053
Secondary ID
Status Withdrawn
Phase Early Phase 1
First received
Last updated
Start date March 11, 2021
Est. completion date March 11, 2021

Study information
Verified date March 2021
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators are performing this research study to investigate the efficacy of local infiltration of the surgical wound combining dexmedetomidine, ropivacaine, and ketorolac (treatment group) versus the current standard of care (historical control group), for post-operative pain management.

Description:

During this research study, patients recommended for a rectus sheath block during surgery will receive a novel combination of non-opioid drugs. Data from the treatment group will be compared to surgical outcomes of a historically matched control group to investigate the ability of this drug combination to reduce post-operative pain and post-operative opioid consumption.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date March 11, 2021
Est. primary completion date March 11, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Age greater than 18 years - American Society of Anesthesiologist Physical Status Classification 1-3 - Undergoing surgery requiring a rectus sheath block Exclusion Criteria: - American Society of Anesthesiologist Physical Status Classification of 4 or beyond - history of opiate of illicit substance abuse, chronic pain, or neurological dysfunction

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Multimodal analgesia
Subjects will be given a rectus sheath block containing dexmedetomidine, ropivacaine, and ketorolac

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Massachusetts General Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Change in post-operative opioid consumption Decreased post-operative opioid consumption associated with use of multimodal analgesia 48 hours
Primary Change in post-operative pain scores Decreased post-operative pain scores associated with use of multimodal analgesia 48 hours
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