Endometriosis; PeritoneumNCT04735770
LTAP Block in Endometriosis Surgery - a Randomised Controlled Double-blind Trial
A study testing Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine in people with Endometriosis; Peritoneum and Postoperative Pain, run by Oulu University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis; Peritoneum, Postoperative Pain
- What is being tested?
- Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFinland
- Study dates
- 1 May 2021to 22 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Surgery indicated because of pain caused by diagnosed or suspected peritoneal endometriosis
- ASA class 1-3
- Patient is capable of giving informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopically Inserted Transversus Abdominis Plane Block Versus Wound Local Anesthesia in Laparoscopic Endometriosis Surgery: a Prospective Randomized Controlled Double-blinded LTAP-trial
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.
Read the 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.
- Conditions
- Endometriosis; Peritoneum, Postoperative Pain
- Being tested
- Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine
- Keywords
- endometriosis, postoperative pain management, laparoscopic surgery, gynecological surgery
- Medical subject headings
- Endometriosis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaineProcedure or surgery
Postoperative pain management
| Study group | Role | What they receive |
|---|---|---|
| LTAP | Experimental | Patients receive laparoscopically inserted TAP block with levobupivacain and local wound anesthesia injections with saline. Receives: 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. Receives: Procedure: Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
Oxicodone consumption measured via PCA-pump in Morphine equivalents
Measured: 24 hours
Secondary outcomes (4)
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
Measured: 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)
NRS (numeric rating scale) with 0 (minimum) meaning no pain and 10 (maximum) meaning the worst imaginable pain
Measured: 6 months postop
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
Measured: 6 months postop
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)
Measured: Up to 6 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 May 2021
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endometriosis; PeritoneumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Terho, Oulu University Hospital
- Investigators
- Sari Koivurova, MD, PhD, Principal investigator, Oulu University Hospital, Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735770
- Sponsor's protocol ID
- OuluUH/Urogyn
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2021
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised data can be shared upon reasonable request to the authors.
Publications
Terho AM, Puhto T, Laru J, Uimari O, Ohtonen P, Rautio T, Koivurova S. Laparoscopically guided transversus abdominis plane block versus local wound infiltration analgesia in laparoscopic surgery for peritoneal endometriosis: A prospective randomized controlled double-blinded LTAP-trial. Acta Obstet Gynecol Scand. 2026 Jun;105(6):1032-1042. doi: 10.1111/aogs.70220. Epub 2026 Apr 30.
PubMed 42062238Terho 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.
PubMed 35042563
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopically Inserted Transversus Abdominis Plane Block Versus Wound Local Anesthesia in Laparoscopic Endometriosis Surgery: a Prospective Randomized Controlled Double-blinded LTAP-trial
- ClinicalTrials.gov ID
- NCT04735770
- Acronym / sponsor ID
- OuluUH/Urogyn
- Conditions
- Endometriosis; Peritoneum, Postoperative Pain
- Keywords
- endometriosis, postoperative pain management, laparoscopic surgery, gynecological surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LTAP | Experimental | Procedure: Postoperative pain management: LTAP block or local wound anesthesia with levobupivacainePatients receive laparoscopically inserted TAP block with levobupivacain and local wound anesthesia injections with saline. |
| Local wound analgesia | Active comparator | Procedure: Postoperative pain management: LTAP block or local wound anesthesia with levobupivacainePatients receive laparoscopically inserted TAP block with saline and local wound anesthesia injections with levobupivacaine. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Surgery indicated because of pain caused by diagnosed or suspected peritoneal endometriosis
- ASA class 1-3
- Patient is capable of giving informed consent
Key exclusion criteria (5 listed)
- Obstructive sleep apnea
- ASA class >4
- Other significant risks associated with opioid use
- Contraindications for local anesthetics or NSAIDs
- Regular opioid consumption before operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative pain management: LTAP block or local wound anesthesia with levobupivacainePostoperative pain management | Procedure or surgery | LTAP, Local wound analgesia |
Primary outcome
Postoperative opioid consumption
Time frame: 24 hours
Oxicodone consumption measured via PCA-pump in Morphine equivalents
4 secondary outcomes
Postoperative pain assessed by NRS (numeric rating scale)
Time frame: 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)
Time frame: 6 months postop
Quality of life at six months postoperatively; assessed by EHP-30 (endometriosis-related health profile) (questionnaires sent to the patients)
Time frame: 6 months postop
Intra- or postoperative complications
Time frame: Up to 6 months postop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Derived from this study: PubMed 42062238Terho AM, Puhto T, Laru J, Uimari O, Ohtonen P, Rautio T, Koivurova S. Laparoscopically guided transversus abdominis plane block versus local wound infiltration analgesia in laparoscopic surgery for peritoneal endometriosis: A prospective randomized controlled double-blinded LTAP-trial. Acta Obstet Gynecol Scand. 2026 Jun;105(6):1032-1042. doi: 10.1111/aogs.70220. Epub 2026 Apr 30.
- Derived from this study: PubMed 35042563Terho 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.
- Individual participant dataSharing planned: No. Anonymised data can be shared upon reasonable request to the authors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sari Koivurova, MD, PhD principal investigator
Oulu University Hospital, Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine in people with Endometriosis; Peritoneum and Postoperative Pain, run by Oulu University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04735770, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.