Does intravenous lidocaine reduce opioid requirements after day case gynaecological laparoscopy? - Lidocaine for gynaecological laparoscopy v1.2

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023350-37-GB

Enrollment

Registered

2011-04-27

Start date

2011-05-12

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Pain after laparoscopic gyaecological surgery

Interventions

Trade Name: Lidocaine Hydrochloride BP 1.0% w/v Product Name: lidocaine 1.0% w/v Product Code: PL 02848/0002R Pharmaceutical Form: Injection INN or Proposed INN: lidocaine 1.0% w/v Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult female patients of ASA I or II scheduled for elective day case gynaecological laparoscopic procedure (laparoscopy +/- diathermy)with the exception of laparoscopic tubal ligation. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Inability to give informed consent Patients undergoing laparoscopy with tubal ligation Pregnancy Intolerance or allergy to non-steroidal anti inflammatory agents (NSAIDS) Intolerance or allergy to paracetamol Intolerance or allergy to lignocaine or other amide local anaesthetic agent Renal or hepatic impairment Congestive cardiac failure, sino-atrial disorders, atrio-ventricular block (all grades) Patients recieving treatment with beta blocking agents Patients receiving antipsychotic agents which prolong the QT interval Patients receiving treatment with Atazanavir, Lopinavir, Darunavir, Fosamprenavir Patients suffering from hypokalaemia (K+ < 3.5mmol/L) Acute porphyria Myasthenia gravis ASA status III or IV Patients prescribed pre-operative opioid analgesic agents Active gastro-oesphageal reflux disease, patients receiving regular cimetidine Patients scheduled for laparoscopy plus microwave endometrial ablation therapy

Design outcomes

Primary

Measure	Time frame
Main Objective: Does a single bolus of intravenous lidocaine reduce opioid analgesic requirements after day case gynaecological laparoscopic procedures?;Secondary Objective: Are there any adverse effects demostrable with the technique? Is there any reduction in nausea and vomiting demonstrable in the treatment group? Is there a difference in time to discharge home between groups?;Primary end point(s): Difference in total dose of fentanyl required to obtain pain score <2 after operation between treatment and placebo groups.	—

Measure

Time frame

Main Objective: Does a single bolus of intravenous lidocaine reduce opioid analgesic requirements after day case gynaecological laparoscopic procedures?;Secondary Objective: Are there any adverse effects demostrable with the technique? Is there any reduction in nausea and vomiting demonstrable in the treatment group? Is there a difference in time to discharge home between groups?;Primary end point(s): Difference in total dose of fentanyl required to obtain pain score <2 after operation between treatment and placebo groups.

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Countries

United Kingdom

Outcome results

None listed

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