Comparison of the efficacy of two analgesic techniques for pain control in prostate surgery by laparoscopic approach

Comparison between mid-axillary ultrasound-guided transversus abdominis plane (TAP) block and local wound infiltration for postoperative analgesia in laparoscopic radical prostatectomy. Impact on early discharge.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004089-16-ES

Enrollment

Registered

2020-05-28

Start date

2020-05-06

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Prostate cancer MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Ropivacaine Product Name: Ropivacaine Pharmaceutical Form: Solution for solution for injection INN or Proposed INN: ROPIVACAINE CAS Number: 84057-95-4 Concentration unit: mg/ml milligram(s

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Informed consent form signed and dated, and willingness and ability to accomplish the protocol requirements 2. Histologically confirmed prostate adenocarcinoma 3. Candidate for radical surgery by laparoscopic approach 4. Age> 18 years 5. Feasibility of performing regular monitoring 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Patients who do not agree to participate in the study 2. History of allergy to local anesthetics and opioid 3. Patients in chronic opioid treatment 4. Age <18 years

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the effectiveness of postoperative analgesia through local infiltration of surgical wounds with respect to the transversus abdominis plane block.;Secondary Objective: - Length of in-hospital stay - Evaluation time to intake - Evaluation time to the first flatus - Evaluation time to sitting position - Evaluation time to perambulation;Primary end point(s): Assessment of acute postoperative pain;Timepoint(s) of evaluation of this end point: Assessment of acute postoperative pain at 1 hour, at 2 hours, at 3 hours, at 4 hours, at 6 hours, at 12 hours, at 18 hours, at 24 hours, at 36 hours and at 48 hours after the end of the surgery	—

Measure

Time frame

Main Objective: Evaluation of the effectiveness of postoperative analgesia through local infiltration of surgical wounds with respect to the transversus abdominis plane block.;Secondary Objective: - Length of in-hospital stay - Evaluation time to intake - Evaluation time to the first flatus - Evaluation time to sitting position - Evaluation time to perambulation;Primary end point(s): Assessment of acute postoperative pain;Timepoint(s) of evaluation of this end point: Assessment of acute postoperative pain at 1 hour, at 2 hours, at 3 hours, at 4 hours, at 6 hours, at 12 hours, at 18 hours, at 24 hours, at 36 hours and at 48 hours after the end of the surgery

—

Secondary

Measure	Time frame
Secondary end point(s): - Evaluation of the first flatus - Assessment of the start intake - Assessment of the start sitting - Assessment of the start perambulation - Record the numer of days hospitalized;Timepoint(s) of evaluation of this end point: - Evaluation of the first flatus during the stay in the post-anaesthetic care unit and in the conventional hospitalization ward. - Assessment of the start intake during the stay in the post-anaesthetic care unit and in the conventional hospitalization ward. - Assessment of the start sitting position during the stay in conventional hospitalization ward. - Assessment of the start perambulation during the stay in conventional hospitalization ward. - Record the number of days hospitalized after hospital discharge	—

Measure

Time frame

Secondary end point(s): - Evaluation of the first flatus - Assessment of the start intake - Assessment of the start sitting - Assessment of the start perambulation - Record the numer of days hospitalized;Timepoint(s) of evaluation of this end point: - Evaluation of the first flatus during the stay in the post-anaesthetic care unit and in the conventional hospitalization ward. - Assessment of the start intake during the stay in the post-anaesthetic care unit and in the conventional hospitalization ward. - Assessment of the start sitting position during the stay in conventional hospitalization ward. - Assessment of the start perambulation during the stay in conventional hospitalization ward. - Record the number of days hospitalized after hospital discharge

—

Countries

Spain

Contacts

Public ContactAna Tejedor Navarro

Consorci Sanitari integral

ana.tejedor@hotmail.comEspañ9355312007265

Outcome results

None listed

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