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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-12-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endometriosis; Peritoneum Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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LTAP

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Postoperative pain management

Local wound analgesia

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Postoperative pain management

Interventions

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

Postoperative pain management

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No