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

Primary Purpose

Endometriosis; Peritoneum, Postoperative Pain

Status

Recruiting

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Endometriosis; Peritoneum focused on measuring endometriosis, postoperative pain management, laparoscopic surgery, gynecological surgery

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Oulu mUniversity HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LTAP

Local wound analgesia

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative opioid consumption

Oxicodone consumption measured via PCA-pump in Morphine equivalents

Secondary Outcome Measures

Postoperative pain assessed by NRS (numeric rating scale)

NRS (numeric rating scale) with 0 (minimum) meaning no pain and 10 (maximum) meaning the worst imaginable pain

Pain at six months postoperatively; assessed by NRS (numeric rating scale), (questionnaires sent to the patients)

NRS (numeric rating scale) with 0 (minimum) meaning no pain and 10 (maximum) meaning the worst imaginable pain

Quality of life at six months postoperatively; assessed by EHP-30 (endometriosis-related health profile) (questionnaires sent to the patients)

EHP-30 (endometriosis health profile) with 0% meaning no effect on quality of life and 100% meaning maximum worsening effect on quality of life

Intra- or postoperative complications

Blood loss (millilitres for each participant), Reoperation (number of participants; yes/no), Hospital stay (hours/days for each participant), Readmission (number of participants for each study group), complications according to Clavien Dindo classification (Grade I meaning any deviation from the normal postoperative course; up to grade V meaning death of patient)

Full Information

NCT ID

NCT04735770

First Posted

January 19, 2021

Last Updated

September 20, 2022

Sponsor

Oulu University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04735770

Brief Title

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

Official Title

Laparoscopically Inserted Transversus Abdominis Plane Block Versus Wound Local Anesthesia in Laparoscopic Endometriosis Surgery: a Prospective Randomized Controlled Double-blinded LTAP-trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oulu University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometriosis; Peritoneum, Postoperative Pain

Keywords

endometriosis, postoperative pain management, laparoscopic surgery, gynecological surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LTAP

Arm Type

Experimental

Arm Description

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

Arm Title

Local wound analgesia

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

Postoperative pain management

Primary Outcome Measure Information:

Title

Postoperative opioid consumption

Description

Oxicodone consumption measured via PCA-pump in Morphine equivalents

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Postoperative pain assessed by NRS (numeric rating scale)

Description

NRS (numeric rating scale) with 0 (minimum) meaning no pain and 10 (maximum) meaning the worst imaginable pain

Time Frame

Recovery room immediately postoperatively; on ward 6, 12 and 24 hours postoperatively

Title

Pain at six months postoperatively; assessed by NRS (numeric rating scale), (questionnaires sent to the patients)

Description

NRS (numeric rating scale) with 0 (minimum) meaning no pain and 10 (maximum) meaning the worst imaginable pain

Time Frame

6 months postop

Title

Quality of life at six months postoperatively; assessed by EHP-30 (endometriosis-related health profile) (questionnaires sent to the patients)

Description

EHP-30 (endometriosis health profile) with 0% meaning no effect on quality of life and 100% meaning maximum worsening effect on quality of life

Time Frame

6 months postop

Title

Intra- or postoperative complications

Description

Time Frame

Up to 6 months postop

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anna M Terho, MD

Phone

+358405354467

anna.terho@fimnet.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sari Koivurova, MD, PhD

Organizational Affiliation

Oulu University Hospital, Department of Obstetrics and Gynecology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oulu mUniversity Hospital

City

Oulu

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna M Terho, MD

Phone

+3589405354467

anna.terho@fimnet.fi

First Name & Middle Initial & Last Name & Degree

Sari Koivurova, PhD

Phone

+35883153082

sari.koivurova@oulu.fi

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Anonymised data can be shared upon reasonable request to the authors.

Citations:

PubMed Identifier

35042563

Citation

Terho A, Puhto T, Laru J, Uimari O, Ohtonen P, Rautio T, Koivurova S. Laparoscopically guided transversus abdominis plane block versus local wound analgesia in laparoscopic surgery for peritoneal endometriosis: study protocol for a prospective randomized controlled double-blinded LTAP-trial. Trials. 2022 Jan 18;23(1):55. doi: 10.1186/s13063-022-06004-6.

Results Reference

derived

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

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