Efficacy of Rectal Sheath Analgesia After Midline Laparotomy

NCT ID: NCT02869841

Last Updated: 2023-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery Pain Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continuous rectus sheath analgesia

Local anesthetic continuous infusion with infusion pumps

Group Type ACTIVE_COMPARATOR

Levobupivacaine continuous infusion

Intervention Type DRUG

Levobupivacaine continuous infusion to rectus sheath catheters

Bolus rectus sheath analgesia

Bolus administration of local anesthetic

Group Type ACTIVE_COMPARATOR

levobupivacaine bolus dosing

Intervention Type DRUG

Levobupivacaine bolus dosing to rectus sheath catheters

Single dose rectus sheath analgesia

single dose administration of local anesthetic

Group Type ACTIVE_COMPARATOR

single bolus of levobupivacaine

Intervention Type DRUG

Levobupivacaine single dose to rectus sheath catheters

Placebo

no rectus sheath analgesia

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

No rectus sheath analgesia

Interventions

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Levobupivacaine continuous infusion

Levobupivacaine continuous infusion to rectus sheath catheters

Intervention Type DRUG

levobupivacaine bolus dosing

Levobupivacaine bolus dosing to rectus sheath catheters

Intervention Type DRUG

single bolus of levobupivacaine

Levobupivacaine single dose to rectus sheath catheters

Intervention Type DRUG

Placebo

No rectus sheath analgesia

Intervention Type OTHER

Other Intervention Names

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continuous infusion group bolus group single dose group no rectus sheath catheters

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Admescope Ltd

INDUSTRY

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matti Eskelinen, Professor

Role: STUDY_CHAIR

Kuopio University Hospital

Locations

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Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Site Status

Countries

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Finland

Other Identifiers

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2011-10-14

Identifier Type: -

Identifier Source: org_study_id

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