Efficacy of Rectal Sheath Analgesia After Midline Laparotomy

Surgery Clinical Trial

— Rektus-puu  

Official title:

Efficacy of Rectal Sheath Analgesia After Midline Laparotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869841
• Other study ID #: 2011-10-14
• Status: Completed
• Phase: Phase 4
• Start date: January 2012
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2020
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 31, 2022
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Postoperative
• Pain, Postoperative
• Surgery

Intervention

Drug:
• Levobupivacaine continuous infusion
Levobupivacaine continuous infusion to rectus sheath catheters
• levobupivacaine bolus dosing
Levobupivacaine bolus dosing to rectus sheath catheters
• single bolus of levobupivacaine
Levobupivacaine single dose to rectus sheath catheters

Other:
• Placebo
No rectus sheath analgesia

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio	Northern Savo

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	Admescope Ltd

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of rescue analgesic used for pain relief	From onset of rectus sheath analgesia	Time 0 h up to 48 h postoperatively
Secondary	Maximum levobupivacaine plasma concentration	Maximum levobupivacaine plasma concentration	Time 0 h to 48 h postoperatively
Secondary	maximum rescue analgesic concentration	maximum rescue analgesic concentration	time 0 h to 48 h postoperatively