Efficacy of Rectal Sheath Analgesia After Midline Laparotomy
This trial is active, not recruiting.
|Conditions||surgery, pain postoperative|
|Treatments||levobupivacaine continuous infusion, levobupivacaine bolus dosing, single bolus of levobupivacaine, placebo|
|Sponsor||Kuopio University Hospital|
|Start date||January 2012|
|End date||July 2015|
|Trial size||80 participants|
|Trial identifier||NCT02869841, 2011-10-14|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Amount of rescue analgesic used for pain relief
time frame: Time 0 h up to 48 h postoperatively
levobupivacaine plasma concentration
time frame: Time 0 h to 48 h postoperatively
rescue analgesic concentration
time frame: time 0 h to 48 h postoperatively
Male or female participants from 18 years up to 80 years old.
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
|Official title||Efficacy of Rectal Sheath Analgesia After Midline Laparotomy|
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