NCT04735770

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2023

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

2.6 years

First QC Date

January 19, 2021

Last Update Submit

January 10, 2024

Conditions

Endometriosis; PeritoneumPostoperative Pain

Keywords

endometriosispostoperative pain managementlaparoscopic surgerygynecological surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

    Oxicodone consumption measured via PCA-pump in Morphine equivalents

    24 hours

Secondary Outcomes (4)

  • Postoperative pain assessed by NRS (numeric rating scale)

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

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

    6 months postop

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

    6 months postop

  • Intra- or postoperative complications

    Up to 6 months postop

Study Arms (2)

LTAP

EXPERIMENTAL

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

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

Local wound analgesia

ACTIVE COMPARATOR

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

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

Interventions

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

Postoperative pain management

LTAPLocal wound analgesia

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu mUniversity Hospital

Oulu, Finland

Location

Related Publications (1)

  • 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.

    PMID: 35042563DERIVED

MeSH Terms

Conditions

EndometriosisPain, Postoperative

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Sari Koivurova, MD, PhD

    Oulu University Hospital, Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2021

First Posted

February 3, 2021

Study Start

May 1, 2021

Primary Completion

December 22, 2023

Study Completion

December 22, 2023

Last Updated

January 11, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

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

Locations

FI(1)