This trial is active, not recruiting.

Conditions surgery, pain postoperative
Treatments levobupivacaine continuous infusion, levobupivacaine bolus dosing, single bolus of levobupivacaine, placebo
Phase phase 4
Sponsor Kuopio University Hospital
Collaborator Admescope Ltd
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Local anesthetic continuous infusion with infusion pumps
levobupivacaine continuous infusion
Levobupivacaine continuous infusion to rectus sheath catheters
(Active Comparator)
Bolus administration of local anesthetic
levobupivacaine bolus dosing
Levobupivacaine bolus dosing to rectus sheath catheters
(Active Comparator)
single dose administration of local anesthetic
single bolus of levobupivacaine
Levobupivacaine single dose to rectus sheath catheters
(Placebo Comparator)
no rectus sheath analgesia
No rectus sheath analgesia

Primary Outcomes

Amount of rescue analgesic used for pain relief
time frame: Time 0 h up to 48 h postoperatively

Secondary Outcomes

levobupivacaine plasma concentration
time frame: Time 0 h to 48 h postoperatively
rescue analgesic concentration
time frame: time 0 h to 48 h postoperatively

Eligibility Criteria

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

Additional Information

Official title Efficacy of Rectal Sheath Analgesia After Midline Laparotomy
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Kuopio University Hospital.