Efficacy of Rectal Sheath Analgesia After Midline Laparotomy (Rektus-puu)

Kuopio University Hospital

Status and phase: Completed; Phase 4

Conditions: Surgery; Pain Postoperative

Treatments: Other: Placebo; Drug: Levobupivacaine continuous infusion; Drug: levobupivacaine bolus dosing; Drug: single bolus of levobupivacaine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02869841

2011-10-14

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 4 patient groups, including a placebo group

Continuous rectus sheath analgesia

Active Comparator group

Description:

Local anesthetic continuous infusion with infusion pumps

Treatment:

Drug: Levobupivacaine continuous infusion

Bolus rectus sheath analgesia

Active Comparator group

Description:

Bolus administration of local anesthetic

Treatment:

Drug: levobupivacaine bolus dosing

Single dose rectus sheath analgesia

Active Comparator group

Description:

single dose administration of local anesthetic

Treatment:

Drug: single bolus of levobupivacaine

Placebo

Placebo Comparator group

Description:

no rectus sheath analgesia

Treatment:

Other: Placebo