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Efficacy of Rectal Sheath Analgesia After Midline Laparotomy

NCT02869841 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2023-10-27

No results posted yet for this study

Summary

Midline laparotomy is commonly used in emergency and elective cancer surgery and patients need effective and safe pain treatment after this type of surgery. Nowadays modern anticoagulant therapy may prevent use of central regional blocks in pain management. Therefore in the present study the efficacy and safety of rectus sheath analgesia is studied using different administration techniques. The primary aim is the efficacy of the rectus sheath analgesia measured with pain ratings and the amount rescue opioid used.

Secondary aims were concentrations of local anesthetic, rescue opioid and satisfaction to analgesia method used.

Conditions

  • Surgery
  • Pain Postoperative

Interventions

DRUG

Levobupivacaine continuous infusion

Levobupivacaine continuous infusion to rectus sheath catheters

DRUG

levobupivacaine bolus dosing

Levobupivacaine bolus dosing to rectus sheath catheters

DRUG

single bolus of levobupivacaine

Levobupivacaine single dose to rectus sheath catheters

OTHER

Placebo

No rectus sheath analgesia

Sponsors & Collaborators

  • Admescope Ltd

    collaborator INDUSTRY

  • Kuopio University Hospital

    lead OTHER

Principal Investigators

  • Matti Eskelinen, Professor · Kuopio University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2018-07-31
Completion
2022-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02869841 on ClinicalTrials.gov