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

Postoperative Pain Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04735770
• Other study ID #: OuluUH/Urogyn
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 22, 2023

Study information

• Verified date: January 2024
• Source: Oulu University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 22, 2023
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis; Peritoneum
• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Finland	Oulu mUniversity Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid consumption	Oxicodone consumption measured via PCA-pump in Morphine equivalents	24 hours
Secondary	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	Recovery room immediately postoperatively; on ward 6, 12 and 24 hours postoperatively
Secondary	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	6 months postop
Secondary	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	6 months postop
Secondary	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)	Up to 6 months postop