LTAP Block in Endometriosis Surgery - a Randomised Controlled Double-blind Trial

Oulu University Hospital

Status: Completed

Conditions: Postoperative Pain; Endometriosis; Peritoneum

Treatments: Procedure: Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04735770

OuluUH/Urogyn

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of laparoscopically inserted transversus abdominis plane block (LTAP) in comparison to local wound analgesia in laparoscopic surgery due to suspected or diagnosed peritoneal endometriosis.

Full description

The LTAP-trial is a prospective randomized controlled double-blinded study comparing the efficacy and safety of LTAP with local wound analgesia in laparoscopic endometriosis surgery. Patients are randomized to receive LTAP with levobupivacain and wound infiltration with placebo or wound infiltration with levobupivacain and LTAP with placebo. The primary outcome is postoperative opioid consumption measured by Patient Controlled Analgesia -pump (PCA). Secondly, subjective postoperative pain up to 24 h postoperatively will be measured by Numeric Rating Scale (NRS). Additional outcome measures are factors related to recovery and length of stay in the hospital as well as a 6 month follow-up survey regarding pain and general wellbeing after surgery. A total of 46 patients will be randomized in a proportion of 1:1.

Enrollment: 46 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Surgery indicated because of pain caused by diagnosed or suspected peritoneal endometriosis
• ASA class 1-3
• Patient is capable of giving informed consent

Exclusion criteria

• Obstructive sleep apnea
• ASA class >4
• Other significant risks associated with opioid use
• Contraindications for local anesthetics or NSAIDs
• Regular opioid consumption before operation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

LTAP

Experimental group

Description:

Patients receive laparoscopically inserted TAP block with levobupivacain and local wound anesthesia injections with saline.

Treatment:

Procedure: Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine

Local wound analgesia

Active Comparator group

Description:

Patients receive laparoscopically inserted TAP block with saline and local wound anesthesia injections with levobupivacaine.

Treatment:

Procedure: Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine