NCT02869841

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_4 surgery

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4 surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 27, 2023

Status Verified

August 1, 2020

Enrollment Period

6.5 years

First QC Date

August 12, 2016

Last Update Submit

October 25, 2023

Conditions

SurgeryPain Postoperative

Keywords

laparotomypainrectus sheath block

Outcome Measures

Primary Outcomes (1)

  • Amount of rescue analgesic used for pain relief

    From onset of rectus sheath analgesia

    Time 0 h up to 48 h postoperatively

Secondary Outcomes (2)

  • Maximum levobupivacaine plasma concentration

    Time 0 h to 48 h postoperatively

  • maximum rescue analgesic concentration

    time 0 h to 48 h postoperatively

Study Arms (4)

Continuous rectus sheath analgesia

ACTIVE COMPARATOR

Local anesthetic continuous infusion with infusion pumps

Drug: Levobupivacaine continuous infusion

Bolus rectus sheath analgesia

ACTIVE COMPARATOR

Bolus administration of local anesthetic

Drug: levobupivacaine bolus dosing

Single dose rectus sheath analgesia

ACTIVE COMPARATOR

single dose administration of local anesthetic

Drug: single bolus of levobupivacaine

Placebo

PLACEBO COMPARATOR

no rectus sheath analgesia

Other: Placebo

Interventions

Levobupivacaine continuous infusionDRUG

Levobupivacaine continuous infusion to rectus sheath catheters

Also known as: continuous infusion group
Continuous rectus sheath analgesia
levobupivacaine bolus dosingDRUG

Levobupivacaine bolus dosing to rectus sheath catheters

Also known as: bolus group
Bolus rectus sheath analgesia
single bolus of levobupivacaineDRUG

Levobupivacaine single dose to rectus sheath catheters

Also known as: single dose group
Single dose rectus sheath analgesia
PlaceboOTHER

No rectus sheath analgesia

Also known as: no rectus sheath catheters
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Matti Eskelinen, Professor

    Kuopio University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2016

First Posted

August 17, 2016

Study Start

January 1, 2012

Primary Completion

July 1, 2018

Study Completion

December 31, 2022

Last Updated

October 27, 2023

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)