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Intraoperative Clonidine for Postoperative Pain Management in Patients Undergoing Surgical Treatment for Endometriosis (CLONIPAIN)

Primary Purpose

Endometriosis, Postoperative Pain, Pain, Acute

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Clonidine
Isotonic saline
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

• Patients scheduled for surgical laparoscopic treatment of endometriosis at Aarhus University Hospital

Exclusion Criteria:

  • Age < 18 years
  • American Society of Anesthesiologists (ASA) physical status IV or V
  • Allergy to clonidine
  • Inability to provide informed consent
  • Known severe renal insufficiency
  • Known severe bradyarrhythmia
  • Pregnancy, lactation:
  • Daily opioid consumption the last 7 days before surgery
  • Pain intensity >5 on more than half of the days during the last month

Sites / Locations

  • Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Clonidine

Isotonic saline

Arm Description

A 100 ml isotonic saline will be mixed with 1 ml clonidine (150 μg). The blinded 100 ml bag including isotonic saline and clonidine 150 μg will be infused over 5-10 min., immediately after intubation.

A 100 ml isotonic saline will be mixed with 1 ml isotonic saline. The blinded 100 ml bag including isotonic saline will be infused over 5-10 min., immediately after intubation.

Outcomes

Primary Outcome Measures

Cumulative opioid consumption 0-3 hours
Opioid consumption within the first 3 hours after arrival at the PACU

Secondary Outcome Measures

Cumulative opioid consumption 0-6 hours
Opioid consumption within the first 6 hours after arrival at the PACU
Pain intensity at rest
Pain intensity at rest (NRS; 0-10) at 0, 30, 60, 90 and 120 minutes after arrival at the PACU
Pain intensity during coughing
Pain intensity during coughing at 0, 30, 60, 90 and 120 minutes after arrival at the PACU
Shivering
Shivering at 0, 60 and 120 minutes after arrival at the PACU
Sedation (Ramsey Sedation Score 1-6)
Sedation at 0, 60 and 120 minutes after arrival at the PACU
PONV
Nausea and/or vomiting at 0, 60 and 120 minutes after arrival at the PACU
Discharge from the PACU
Time for discharge from the PACU (hours and minutes)

Full Information

First Posted
September 26, 2022
Last Updated
October 6, 2022
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05560230
Brief Title
Intraoperative Clonidine for Postoperative Pain Management in Patients Undergoing Surgical Treatment for Endometriosis
Acronym
CLONIPAIN
Official Title
Intraoperative Clonidine for Postoperative Pain Management in Patients Undergoing Surgical Treatment for Endometriosis: a Prospective, Double-blind, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
October 3, 2022 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The role of a single dose of intraoperative clonidine on postoperative opioid requirements, pain intensity and opioid-related side effects in patients undergoing surgical treatment for endometriosis remains scarcely explored. A prospective double-blind, randomised controlled trial investigating the effect of a single-dose of intraoperative clonidine in patients undergoing surgical treatment for endometriosis is therefore conducted.
Detailed Description
Background with aim: Acute postoperative pain is a major and common concern for the large number of patients who undergo surgery each year. Despite advances in pain management strategies, many patients continue to suffer from moderate-to-severe pain during the early postoperative period. This is concerning as unrelieved pain can result in decreased patient satisfaction, increased morbidity, prolonged hospital length-of-stay and increased risk of persistent pain. Effective treatment of acute postoperative pain should therefore be prioritized. Opioid analgesics remain the mainstay treatment for postoperative pain. The potential benefits of opioid therapy for acute pain are short-term pain control. However, there are several potential harms associated with opioid use which may outweigh the benefits including sedation, nausea, vomiting, constipation and risk of long-term use. In this respect, a single dose of clonidine could provide stable analgesia and potentially reduce the need for shorter-acting opioids. Therefore, the investigators decided to carry out the present study with the aim to examine the analgesic efficacy and safety of intraoperatively administered intravenous clonidine in patients undergoing surgical treatment for endometriosis on postoperative opioid consumption, pain intensity and opioid-related side effects. Method: 120 patients undergoing surgical treatment for endometriosis will be included in this prospective, randomized, double-blind, controlled trial with two arms: an intervention arm (clonidine 150 microgram) and a control arm (isotonic saline). The study will be GCP-monitored, and is approved by the Danish Medicines Agency (2022064017) and the National Committee on Health Research Ethics (2209269). Hypothesis: The investigators hypothesize that a single dose of intraoperatively administered intravenous clonidine will be effective in reducing postoperative opioid requirements, pain intensity and opioid-related side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Postoperative Pain, Pain, Acute, Pain, Acute Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
120 patients undergoing surgical treatment for endometriosis will be included in this prospective, randomized, double-blind, controlled trial with two arms: Intervention arm (clonidine 150 microgram). Control arm (isotonic saline).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomization and study medication will be handled by the hospital pharmacy. All research team members, caregiving clinicians and enrolled patients will be blinded to the study allocation arms and the randomisation list will be concealed until all statistical analyses are made.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clonidine
Arm Type
Experimental
Arm Description
A 100 ml isotonic saline will be mixed with 1 ml clonidine (150 μg). The blinded 100 ml bag including isotonic saline and clonidine 150 μg will be infused over 5-10 min., immediately after intubation.
Arm Title
Isotonic saline
Arm Type
Placebo Comparator
Arm Description
A 100 ml isotonic saline will be mixed with 1 ml isotonic saline. The blinded 100 ml bag including isotonic saline will be infused over 5-10 min., immediately after intubation.
Intervention Type
Drug
Intervention Name(s)
Clonidine
Intervention Description
A single dose of intraoperatively administered intravenous clonidine 150 μg will be infused over 5-10 min., immediately after intubation
Intervention Type
Drug
Intervention Name(s)
Isotonic saline
Intervention Description
A single dose of administered intravenous isotonic saline will be infused over 5-10 min., immediately after intubation
Primary Outcome Measure Information:
Title
Cumulative opioid consumption 0-3 hours
Description
Opioid consumption within the first 3 hours after arrival at the PACU
Time Frame
3 hours after arrival at the PACU
Secondary Outcome Measure Information:
Title
Cumulative opioid consumption 0-6 hours
Description
Opioid consumption within the first 6 hours after arrival at the PACU
Time Frame
6 hours after arrival at the PACU
Title
Pain intensity at rest
Description
Pain intensity at rest (NRS; 0-10) at 0, 30, 60, 90 and 120 minutes after arrival at the PACU
Time Frame
0, 30, 60, 90 and 120 minutes after arrival at the PACU
Title
Pain intensity during coughing
Description
Pain intensity during coughing at 0, 30, 60, 90 and 120 minutes after arrival at the PACU
Time Frame
0, 30, 60, 90 and 120 minutes after arrival at the PACU
Title
Shivering
Description
Shivering at 0, 60 and 120 minutes after arrival at the PACU
Time Frame
0, 60 and 120 minutes after arrival at the PACU
Title
Sedation (Ramsey Sedation Score 1-6)
Description
Sedation at 0, 60 and 120 minutes after arrival at the PACU
Time Frame
0, 60 and 120 minutes after arrival at the PACU
Title
PONV
Description
Nausea and/or vomiting at 0, 60 and 120 minutes after arrival at the PACU
Time Frame
0, 60 and 120 minutes after arrival at the PACU
Title
Discharge from the PACU
Description
Time for discharge from the PACU (hours and minutes)
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Patients scheduled for surgical laparoscopic treatment of endometriosis at Aarhus University Hospital Exclusion Criteria: Age < 18 years American Society of Anesthesiologists (ASA) physical status IV or V Allergy to clonidine Inability to provide informed consent Known severe renal insufficiency Known severe bradyarrhythmia Pregnancy, lactation: Daily opioid consumption the last 7 days before surgery Pain intensity >5 on more than half of the days during the last month
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stine Birkebaek, MD
Phone
53655024
Ext
0045
Email
stibir@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lone Nikolajsen, MD, DMSc
Phone
7846 4317
Email
Lone.nikolajsen@clin.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lone Nikolajsen, MD, DMSc
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stine Birkebaek, MD
Phone
53655024
Ext
0045
Email
stibir@rm.dk
First Name & Middle Initial & Last Name & Degree
Lone Nikolajsen, PhD, DMSc
Phone
7846 4317
Email
Lone.nikolajsen@clin.au.dk
First Name & Middle Initial & Last Name & Degree
Stine Birkebaek, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data will be shared upon reasonable request by other researchers

Learn more about this trial

Intraoperative Clonidine for Postoperative Pain Management in Patients Undergoing Surgical Treatment for Endometriosis

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