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

NCT05560230 | Completed Phase 4

• 1 other identifier: 2022064017
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Postoperative Pain; Pain, Acute; Pain, Acute Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Cumulative opioid consumption 0-6 hours

  6 hours after arrival at the PACU

• Pain intensity at rest

  0, 30, 60, 90 and 120 minutes after arrival at the PACU

• Pain intensity during coughing

  0, 30, 60, 90 and 120 minutes after arrival at the PACU

• Shivering

  0, 60 and 120 minutes after arrival at the PACU

• Sedation (Ramsey Sedation Score 1-6)

  0, 60 and 120 minutes after arrival at the PACU

Study Arms (2)

Clonidine

EXPERIMENTAL

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.

Drug: Clonidine

Isotonic saline

PLACEBO COMPARATOR

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.

Drug: Isotonic saline

Interventions

Clonidine DRUG

A single dose of intraoperatively administered intravenous clonidine 150 μg will be infused over 5-10 min., immediately after intubation

Clonidine

Isotonic saline DRUG

A single dose of administered intravenous isotonic saline will be infused over 5-10 min., immediately after intubation

Isotonic saline

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Endometriosis; Pain, Postoperative; Acute Pain

Interventions

Clonidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Lone Nikolajsen, MD, DMSc

  Aarhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: October 3, 2022
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2024
• Last Updated: August 23, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)