Efficacy of Rectal Sheath Analgesia After Midline Laparotomy

Kuopio University Hospital57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Surgery Pain Postoperative

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Amount of rescue analgesic used for pain relief

From onset of rectus sheath analgesia

Time frame: Time 0 h up to 48 h postoperatively

Secondary Outcomes

Maximum levobupivacaine plasma concentration

Time frame: Time 0 h to 48 h postoperatively

maximum rescue analgesic concentration

Time frame: time 0 h to 48 h postoperatively