A Phase 4 interventional study of Levobupivacaine continuous infusion and levobupivacaine bolus dosing in Surgery and Pain Postoperative, sponsored by Kuopio University Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-27.
Sponsored by Kuopio University Hospital · Phase 4, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 57 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Kuopio University Hospital is the lead sponsor of 132 studies on the registry; 23 are open to participants now.
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Inclusion Criteria: • Body mass index over BMI \<35 kg / m2
Exclusion Criteria:
BMI >35 kg / m2
Local anesthetic continuous infusion with infusion pumps
Drug: Levobupivacaine continuous infusion
Bolus administration of local anesthetic
Drug: levobupivacaine bolus dosing
single dose administration of local anesthetic
Drug: single bolus of levobupivacaine
no rectus sheath analgesia
Other: Placebo
Levobupivacaine continuous infusion to rectus sheath catheters
Also known as: continuous infusion group
Levobupivacaine bolus dosing to rectus sheath catheters
Also known as: bolus group
Levobupivacaine single dose to rectus sheath catheters
Also known as: single dose group
No rectus sheath analgesia
Also known as: no rectus sheath catheters
Amount of rescue analgesic used for pain relief
From onset of rectus sheath analgesia
Time frame: Time 0 h up to 48 h postoperatively
Maximum levobupivacaine plasma concentration
Maximum levobupivacaine plasma concentration
Time frame: Time 0 h to 48 h postoperatively
maximum rescue analgesic concentration
maximum rescue analgesic concentration
Time frame: time 0 h to 48 h postoperatively
Plan to share: No
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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Kuopio University Hospital