Intraperitoneal atomization of levobupivacaine during gynecological laparoscopic procedures : Impact on pain, opioid use and length of recovery room stay (IPLA).

Intraperitoneal atomization of levobupivacaine during gynecological laparoscopic procedures : Impact on pain, opioid use and length of recovery room stay (IPLA). - IPLA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000384-87-BE

Enrollment

Registered

2013-02-15

Start date

2013-03-05

Completion date

Unknown

Last updated

2018-12-10

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

Conditions

Patients who are planned for gynecological laparoscopic interventions on an ambulatory basis. MedDRA version: 14.1 Level: LLT Classification code 10002182 Term: Analgesia System Organ Class: 100000004865

Interventions

Trade Name: Chirocaine 5mg/ml, solution for injection/concentrate for solution for infusion. Product Name: Levobupivacaine Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: LEV

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients who are planned for gynecological laparoscopic interventions on an ambulatory basis. 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Less than 18 year old - Weight less than 50 kg and more than 80 kg - Pregnant - Prisoners - Allergic to topical anesthetics (Amides specifically) - Allergic to Opioids as a class - Currently or within the last 30 days been prescribed an opiate medication - Chronic pain syndrome

Design outcomes

Primary

Measure	Time frame
Primary end point(s): - Post-operative pain intensity and opioid analgesic requirements. - Post-operative shoulder pain intensity.;Timepoint(s) of evaluation of this end point: During the postoperative stay in the ambulatory surgery unit. ;Main Objective: The primary goal is to assess the efficacy of intraperitoneal atomization of levobupivacaine in reducing postoperative pain in patients undergoing gynecological laparoscopic procedures in one-day surgery.;Secondary Objective: to assess the efficacy of intraperitoneal atomization of levobupivacaine in reducing opioid requirements.	—

Measure

Time frame

Primary end point(s): - Post-operative pain intensity and opioid analgesic requirements. - Post-operative shoulder pain intensity.;Timepoint(s) of evaluation of this end point: During the postoperative stay in the ambulatory surgery unit. ;Main Objective: The primary goal is to assess the efficacy of intraperitoneal atomization of levobupivacaine in reducing postoperative pain in patients undergoing gynecological laparoscopic procedures in one-day surgery.;Secondary Objective: to assess the efficacy of intraperitoneal atomization of levobupivacaine in reducing opioid requirements.

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Secondary

Measure	Time frame
Secondary end point(s): - Post-operative pain intensity from hospital discharge until 24 hrs post-operatively. - Post-operative shoulder pain intensity from hospital discharge until 24 hrs post-operatively. - Post-operative nausea and vomiting in the first 24 hrs post-operatively. - Post-operative sedation until hospital discharge. - Time until discharge from recovery room. - Time until discharge from hospital. ;Timepoint(s) of evaluation of this end point: Follow up is foreseen until 24 hrs post-operatively.	—

Measure

Time frame

Secondary end point(s): - Post-operative pain intensity from hospital discharge until 24 hrs post-operatively. - Post-operative shoulder pain intensity from hospital discharge until 24 hrs post-operatively. - Post-operative nausea and vomiting in the first 24 hrs post-operatively. - Post-operative sedation until hospital discharge. - Time until discharge from recovery room. - Time until discharge from hospital. ;Timepoint(s) of evaluation of this end point: Follow up is foreseen until 24 hrs post-operatively.

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Countries

Belgium

Contacts

Public ContactBimetra Clinics

Ghent University Hospital

Trialbureau@uzgent.be+3293320500

Outcome results

None listed

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