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

Primary Purpose

Surgery, Pain Postoperative

Status
Unknown status
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Levobupivacaine continuous infusion
levobupivacaine bolus dosing
single bolus of levobupivacaine
Placebo
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring laparotomy, pain, rectus sheath block

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Continuous rectus sheath analgesia

Bolus rectus sheath analgesia

Single dose rectus sheath analgesia

Placebo

Arm Description

Local anesthetic continuous infusion with infusion pumps

Bolus administration of local anesthetic

single dose administration of local anesthetic

no rectus sheath analgesia

Outcomes

Primary Outcome Measures

Amount of rescue analgesic used for pain relief
From onset of rectus sheath analgesia

Secondary Outcome Measures

levobupivacaine plasma concentration
rescue analgesic concentration

Full Information

First Posted
August 12, 2016
Last Updated
August 26, 2020
Sponsor
Kuopio University Hospital
Collaborators
Admescope Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02869841
Brief Title
Efficacy of Rectal Sheath Analgesia After Midline Laparotomy
Acronym
Rektus-puu
Official Title
Efficacy of Rectal Sheath Analgesia After Midline Laparotomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital
Collaborators
Admescope Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Pain Postoperative
Keywords
laparotomy, pain, rectus sheath block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous rectus sheath analgesia
Arm Type
Active Comparator
Arm Description
Local anesthetic continuous infusion with infusion pumps
Arm Title
Bolus rectus sheath analgesia
Arm Type
Active Comparator
Arm Description
Bolus administration of local anesthetic
Arm Title
Single dose rectus sheath analgesia
Arm Type
Active Comparator
Arm Description
single dose administration of local anesthetic
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
no rectus sheath analgesia
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine continuous infusion
Other Intervention Name(s)
continuous infusion group
Intervention Description
Levobupivacaine continuous infusion to rectus sheath catheters
Intervention Type
Drug
Intervention Name(s)
levobupivacaine bolus dosing
Other Intervention Name(s)
bolus group
Intervention Description
Levobupivacaine bolus dosing to rectus sheath catheters
Intervention Type
Drug
Intervention Name(s)
single bolus of levobupivacaine
Other Intervention Name(s)
single dose group
Intervention Description
Levobupivacaine single dose to rectus sheath catheters
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
no rectus sheath catheters
Intervention Description
No rectus sheath analgesia
Primary Outcome Measure Information:
Title
Amount of rescue analgesic used for pain relief
Description
From onset of rectus sheath analgesia
Time Frame
Time 0 h up to 48 h postoperatively
Secondary Outcome Measure Information:
Title
levobupivacaine plasma concentration
Time Frame
Time 0 h to 48 h postoperatively
Title
rescue analgesic concentration
Time Frame
time 0 h to 48 h postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matti Eskelinen, Professor
Organizational Affiliation
Kuopio University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
State/Province
Northern Savo
ZIP/Postal Code
70029
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Rectal Sheath Analgesia After Midline Laparotomy

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