Efficacy of Rectal Sheath Analgesia After Midline Laparotomy

Phase 4

Completed

• Conditions: Surgery; Pain Postoperative
• Interventions: Drug: Levobupivacaine continuous infusion; Drug: levobupivacaine bolus dosing; Drug: single bolus of levobupivacaine; Other: Placebo

• Registration Number: NCT02869841
• Lead Sponsor: Kuopio University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-17
• Primary Completion: 2018-07
• Status Verified: 2020-08
• Study Completion: 2022-12-31
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous rectus sheath analgesia	Levobupivacaine continuous infusion	Local anesthetic continuous infusion with infusion pumps
Bolus rectus sheath analgesia	levobupivacaine bolus dosing	Bolus administration of local anesthetic
Single dose rectus sheath analgesia	single bolus of levobupivacaine	single dose administration of local anesthetic
Placebo	Placebo	no rectus sheath analgesia

Primary Outcome Measures

Name	Time	Method
Amount of rescue analgesic used for pain relief	Time 0 h up to 48 h postoperatively	From onset of rectus sheath analgesia

Secondary Outcome Measures

Name	Time	Method
Maximum levobupivacaine plasma concentration	Time 0 h to 48 h postoperatively	Maximum levobupivacaine plasma concentration
maximum rescue analgesic concentration	time 0 h to 48 h postoperatively	maximum rescue analgesic concentration

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Northern Savo, Finland