Efficacy of Rectal Sheath Analgesia After Midline Laparotomy (Rektus-puu)

October 25, 2023 updated by: Kuopio University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Northern Savo
      • Kuopio, Northern Savo, Finland, 70029
        • Kuopio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: • Body mass index over BMI <35 kg / m2

  • not pregnancy/adequate contraception
  • no contraindications to the local anaesthetic No contraindications to opioid patient controlled analgesia
  • Informed consent obtained

Exclusion Criteria:

  • • BMI >35 kg / m2

    • Pregnant or breast feeding
    • Contraindication to local anaesthetics
    • Contraindication to opioids
    • Not able to use patient controlled analgesia pump
    • Relaparotomy
    • No informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous rectus sheath analgesia
Local anesthetic continuous infusion with infusion pumps
Drug: Levobupivacaine continuous infusion
Levobupivacaine continuous infusion to rectus sheath catheters
Other Names:
  • continuous infusion group
Active Comparator: Bolus rectus sheath analgesia
Bolus administration of local anesthetic
Drug: levobupivacaine bolus dosing
Levobupivacaine bolus dosing to rectus sheath catheters
Other Names:
  • bolus group
Active Comparator: Single dose rectus sheath analgesia
single dose administration of local anesthetic
Drug: single bolus of levobupivacaine
Levobupivacaine single dose to rectus sheath catheters
Other Names:
  • single dose group
Placebo Comparator: Placebo
no rectus sheath analgesia
Other: Placebo
No rectus sheath analgesia
Other Names:
  • no rectus sheath catheters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of rescue analgesic used for pain relief
Time Frame: Time 0 h up to 48 h postoperatively
From onset of rectus sheath analgesia
Time 0 h up to 48 h postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum levobupivacaine plasma concentration
Time Frame: Time 0 h to 48 h postoperatively
Maximum levobupivacaine plasma concentration
Time 0 h to 48 h postoperatively
maximum rescue analgesic concentration
Time Frame: time 0 h to 48 h postoperatively
maximum rescue analgesic concentration
time 0 h to 48 h postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

Admescope Ltd

Investigators

  • Study Chair: Matti Eskelinen, Professor, Kuopio University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (Estimated)

August 17, 2016

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-10-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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