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OpenTrials
Completed

NCT Number: NCT02869841

Efficacy of Rectal Sheath Analgesia After Midline Laparotomy

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.

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Key information

Conditions

Surgery Neurologic Manifestations Pain Pain Postoperative Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levobupivacaine continuous infusion

Drug

Levobupivacaine continuous infusion to rectus sheath catheters

Other names: continuous infusion group

levobupivacaine bolus dosing

Drug

Levobupivacaine bolus dosing to rectus sheath catheters

Other names: bolus group

single bolus of levobupivacaine

Drug

Levobupivacaine single dose to rectus sheath catheters

Other names: single dose group

Placebo

Other

No rectus sheath analgesia

Other names: no rectus sheath catheters

Primary outcomes

  1. Amount of rescue analgesic used for pain relief

    Time frame: Time 0 h up to 48 h postoperatively

    From onset of rectus sheath analgesia

Secondary outcomes

  1. Maximum levobupivacaine plasma concentration

    Time frame: Time 0 h to 48 h postoperatively

    Maximum levobupivacaine plasma concentration

  2. maximum rescue analgesic concentration

    Time frame: time 0 h to 48 h postoperatively

    maximum rescue analgesic concentration

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

  • Admescope Ltd

Registry information

Acronym: Rektus-puu

Important dates

Study start
2012
Primary completion
2018
Study completion
2022
First posted
Aug 17, 2016
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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