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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02869841
Other study ID # 2011-10-14
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2012
Est. completion date December 31, 2022

Study information

Verified date August 2020
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date December 31, 2022
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Levobupivacaine continuous infusion
Levobupivacaine continuous infusion to rectus sheath catheters
levobupivacaine bolus dosing
Levobupivacaine bolus dosing to rectus sheath catheters
single bolus of levobupivacaine
Levobupivacaine single dose to rectus sheath catheters
Other:
Placebo
No rectus sheath analgesia

Locations

Country Name City State
Finland Kuopio University Hospital Kuopio Northern Savo

Sponsors (2)

Lead Sponsor Collaborator
Kuopio University Hospital Admescope Ltd

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Amount of rescue analgesic used for pain relief From onset of rectus sheath analgesia Time 0 h up to 48 h postoperatively
Secondary Maximum levobupivacaine plasma concentration Maximum levobupivacaine plasma concentration Time 0 h to 48 h postoperatively
Secondary maximum rescue analgesic concentration maximum rescue analgesic concentration time 0 h to 48 h postoperatively
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