Efficacy of Rectal Sheath Analgesia After Midline Laparotomy

Study Overview
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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.

Official Title
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Efficacy of Rectal Sheath Analgesia After Midline Laparotomy

Conditions
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Pain Postoperative, Surgery

Intervention / Treatment
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* Drug: Levobupivacaine continuous infusion
* Drug: levobupivacaine bolus dosing
* Drug: single bolus of levobupivacaine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous rectus sheath analgesia<br>Local anesthetic continuous infusion with infusion pumps | Drug: Levobupivacaine continuous infusion<br>* Levobupivacaine continuous infusion to rectus sheath catheters<br>* Other names: continuous infusion group;|
| Active Comparator: Bolus rectus sheath analgesia<br>Bolus administration of local anesthetic | Drug: levobupivacaine bolus dosing<br>* Levobupivacaine bolus dosing to rectus sheath catheters<br>* Other names: bolus group;|
| Active Comparator: Single dose rectus sheath analgesia<br>single dose administration of local anesthetic | Drug: single bolus of levobupivacaine<br>* Levobupivacaine single dose to rectus sheath catheters<br>* Other names: single dose group;|
| Placebo Comparator: Placebo<br>no rectus sheath analgesia | Other: Placebo<br>* No rectus sheath analgesia<br>* Other names: no rectus sheath catheters;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of rescue analgesic used for pain relief | From onset of rectus sheath analgesia | Time 0 h up to 48 h postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum levobupivacaine plasma concentration | Maximum levobupivacaine plasma concentration | Time 0 h to 48 h postoperatively | 
| maximum rescue analgesic concentration | maximum rescue analgesic concentration | time 0 h to 48 h postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparotomy, pain, rectus sheath block