Clonidine for postoperative pain management in patients undergoing surgical treatment for endometriosis

Intraoperative clonidine for postoperative pain management in patients undergoing surgical treatment for endometriosis: a prospective, double-blind, randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001810-21-DK

Enrollment

120

Registered

2022-06-29

Start date

2022-08-23

Completion date

Unknown

Last updated

2024-08-26

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

Conditions

Endometriosis MedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: Clotaxip, injektionsvæske, opløsning. AMPS 1 ml. Pharmaceutical Form: Solution for injection INN or Proposed INN: Clonidine Other descriptive name: Clonidine hydrochloride Concentration u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients scheduled for surgical laparoscopic treatment of endometriosis at Aarhus University Hospital will be included in the study. 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 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Age 5 on more than half of the days during the last month

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine analgesic efficacy and safety of intraoperatively administered intravenous clonidine in patients undergoing surgical treatment for endometriosis on postoperative opioid consumption ;Secondary Objective: To examine analgesic efficacy of intraoperatively administered intravenous clonidine in patients undergoing surgical treatment for endometriosis on postoperative opioid consumption, pain intensity and opioid-related side effects ;Primary end point(s): The primary outcome is postoperative opioid consumption;Timepoint(s) of evaluation of this end point: 3 hours after arrival at the PACU	—

Measure

Time frame

Main Objective: To examine analgesic efficacy and safety of intraoperatively administered intravenous clonidine in patients undergoing surgical treatment for endometriosis on postoperative opioid consumption ;Secondary Objective: To examine analgesic efficacy of intraoperatively administered intravenous clonidine in patients undergoing surgical treatment for endometriosis on postoperative opioid consumption, pain intensity and opioid-related side effects ;Primary end point(s): The primary outcome is postoperative opioid consumption;Timepoint(s) of evaluation of this end point: 3 hours after arrival at the PACU

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Secondary

Measure	Time frame
Secondary end point(s): • Postoperative opioid consumption • Intensity of pain at rest and during coughing • Shivering • Sedation • Nausea and/or vomiting • Time for discharge from the PACU;Timepoint(s) of evaluation of this end point: • Postoperative opioid consumption within the first 6 hours after arrival at the PACU (or at hospital discharge if sooner than 6 hours) (mean cumulative iv. morphine equivalents in mg) • Intensity of pain at rest and during coughing at 0, 30, 60, 90 and 120 minutes after arrival at the PACU, measured on a Numeric Rating Scale (NRS, 0-10) • Shivering at 0, 60, and 120 minutes after arrival at the PACU (yes/no) • Sedation at 0, 60, and 120 minutes after arrival at the PACU (Ramsay Sedation Score 1-6) • Nausea and/or vomiting 0, 60, and 120 minutes after arrival at the PACU (yes/no) • Time for discharge from the PACU	—

Measure

Time frame

Secondary end point(s): • Postoperative opioid consumption • Intensity of pain at rest and during coughing • Shivering • Sedation • Nausea and/or vomiting • Time for discharge from the PACU;Timepoint(s) of evaluation of this end point: • Postoperative opioid consumption within the first 6 hours after arrival at the PACU (or at hospital discharge if sooner than 6 hours) (mean cumulative iv. morphine equivalents in mg) • Intensity of pain at rest and during coughing at 0, 30, 60, 90 and 120 minutes after arrival at the PACU, measured on a Numeric Rating Scale (NRS, 0-10) • Shivering at 0, 60, and 120 minutes after arrival at the PACU (yes/no) • Sedation at 0, 60, and 120 minutes after arrival at the PACU (Ramsay Sedation Score 1-6) • Nausea and/or vomiting 0, 60, and 120 minutes after arrival at the PACU (yes/no) • Time for discharge from the PACU

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Countries

Denmark

Contacts

Public ContactStine Birkebaek

Aarhus University Hospital, Department of Anaesthesiology

stine.birkebaek@midt.rm.dk+4553655024

Outcome results

None listed

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