Abdominal wall anesthetic versus local wound anesthetic in laparoscopic endometriosis surgery; a prospective randomized controlled double-blinded study

Laparoscopically inserted transversus abdominis plane block versus local wound anesthesia in laparoscopic peritoneal endometriosis surgery: a prospective randomized controlled double-blinded LTAP-trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004353-80-FI

Enrollment

Registered

2020-12-07

Start date

2021-01-04

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The study subjects are patients with endometriosis needing surgical treatment.

Interventions

Trade Name: Chirocaine 2,5mg/ml Pharmaceutical Form: Injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Infiltration Trade Name: Chirocaine 5mg/ml Pharmac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18-50 years. Diagnosed or suspected peritoneal endometriosis. Laparoscopic surgery indicated. ASA 1-3. The study subject is able to understand the study plan and to give informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Sleep-apnea. ASA > 3. Other risk factors related to opioid use. contraindications to opioids or non-steroidal anti-inflammatory drugs. continuous opioid intake preoperatively.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to compare the effect and safety of LTAP (Chirocaine 2,5 mg/ml 40 ml) to local wound analgesia (Chirocaine 5mg/ml 10 ml) treating post-laparoscopic pain measured by postoperative opioid consumption. ;Secondary Objective: As for secondary outcome, postoperative pain will be measured using NRS scaled 1 to 10 at the recovery room, at the ward and at discharge every six hours. Facts related to postoperative recovery (nausea, vomiting, peroral intake, mobilization, complications and time of discharge) will serve as other outcomes and will be measured accordingly. Additionally, a 6-month postoperative follow-up will be conducted using NRS pain inquiry and EHP-30 questionnaire sent to participants.;Primary end point(s): The primary end point of the study is the assumption that LTAP will decrease the postoperative opioid consumption measured by PCA-pump by 50% in comparison to local wound analgesia.;Timepoint(s) of evaluation of this end point: The total opioid consumption will be measured from the beginning of surgery until hospital discharge.	—

Measure

Time frame

Main Objective: The objective of this study is to compare the effect and safety of LTAP (Chirocaine 2,5 mg/ml 40 ml) to local wound analgesia (Chirocaine 5mg/ml 10 ml) treating post-laparoscopic pain measured by postoperative opioid consumption. ;Secondary Objective: As for secondary outcome, postoperative pain will be measured using NRS scaled 1 to 10 at the recovery room, at the ward and at discharge every six hours. Facts related to postoperative recovery (nausea, vomiting, peroral intake, mobilization, complications and time of discharge) will serve as other outcomes and will be measured accordingly. Additionally, a 6-month postoperative follow-up will be conducted using NRS pain inquiry and EHP-30 questionnaire sent to participants.;Primary end point(s): The primary end point of the study is the assumption that LTAP will decrease the postoperative opioid consumption measured by PCA-pump by 50% in comparison to local wound analgesia.;Timepoint(s) of evaluation of this end point: The total opioid consumption will be measured from the beginning of surgery until hospital discharge.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary end points are postoperative pain and facts related to recovery; nausea, vomiting, peroral intake, mobilisation, complications, time to discharge. Additional end points are pain and general health six months after surgery evaluated by questionnaires (NRS, EHP-30).;Timepoint(s) of evaluation of this end point: Secondary end points will be measured every six hours from the beginning of surgery until discharge. Questionnaires will be evaluated six months after surgery.	—

Measure

Time frame

Secondary end point(s): Secondary end points are postoperative pain and facts related to recovery; nausea, vomiting, peroral intake, mobilisation, complications, time to discharge. Additional end points are pain and general health six months after surgery evaluated by questionnaires (NRS, EHP-30).;Timepoint(s) of evaluation of this end point: Secondary end points will be measured every six hours from the beginning of surgery until discharge. Questionnaires will be evaluated six months after surgery.

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Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026