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

Postoperative Pain Clinical Trial

— CLONIPAIN  

Official title:

Intraoperative Clonidine for Postoperative Pain Management in Patients Undergoing Surgical Treatment for Endometriosis: a Prospective, Double-blind, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05560230
• Other study ID #: 2022064017
• Status: Recruiting
• Phase: Phase 4
• Start date: October 3, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2023
• Source: University of Aarhus
• Contact: Stine Birkebaek, MD
• Phone: 53655024
• Email: stibir[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Endometriosis
• Pain, Acute
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Clonidine
A single dose of intraoperatively administered intravenous clonidine 150 µg will be infused over 5-10 min., immediately after intubation
• Isotonic saline
A single dose of administered intravenous isotonic saline will be infused over 5-10 min., immediately after intubation

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative opioid consumption 0-3 hours	Opioid consumption within the first 3 hours after arrival at the PACU	3 hours after arrival at the PACU
Secondary	Cumulative opioid consumption 0-6 hours	Opioid consumption within the first 6 hours after arrival at the PACU	6 hours after arrival at the PACU
Secondary	Pain intensity at rest	Pain intensity at rest (NRS; 0-10) at 0, 30, 60, 90 and 120 minutes after arrival at the PACU	0, 30, 60, 90 and 120 minutes after arrival at the PACU
Secondary	Pain intensity during coughing	Pain intensity during coughing at 0, 30, 60, 90 and 120 minutes after arrival at the PACU	0, 30, 60, 90 and 120 minutes after arrival at the PACU
Secondary	Shivering	Shivering at 0, 60 and 120 minutes after arrival at the PACU	0, 60 and 120 minutes after arrival at the PACU
Secondary	Sedation (Ramsey Sedation Score 1-6)	Sedation at 0, 60 and 120 minutes after arrival at the PACU	0, 60 and 120 minutes after arrival at the PACU
Secondary	PONV	Nausea and/or vomiting at 0, 60 and 120 minutes after arrival at the PACU	0, 60 and 120 minutes after arrival at the PACU
Secondary	Discharge from the PACU	Time for discharge from the PACU (hours and minutes)	24 hours