Efficacy of Rectal Sheath Analgesia After Midline Laparotomy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02869841

Acronym

Rektus-puu

Enrollment

Registered

2016-08-17

Start date

2012-01-31

Completion date

2022-12-31

Last updated

2023-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Postoperative, Surgery

Keywords

laparotomy, pain, rectus sheath block

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.

Interventions

DRUGLevobupivacaine continuous infusion

Levobupivacaine continuous infusion to rectus sheath catheters

DRUGlevobupivacaine bolus dosing

Levobupivacaine bolus dosing to rectus sheath catheters

DRUGsingle bolus of levobupivacaine

Levobupivacaine single dose to rectus sheath catheters

OTHERPlacebo

No rectus sheath analgesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026