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

K

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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