Pain Relief in Laparoscopic Surgery

NCT03867552 | Completed

• 1 other identifier: 19.08/Gynaeco19.01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Pain relief after laparoscopic surgery with the use of an altered gas.

Conditions

Pain, Postoperative; Surgery

Keywords

post-operative pain; recovery; laparoscopy; nitrous oxide

Outcome Measures

Primary Outcomes (1)

• Assessment of post-operative pain with an 11-point numerical rating score (NRS)

  Assessement of pain after laparoscopic surgery with the use of the altered gas compared to standard gas with NRS, where 0 means no pain and 10 means worst imaginable pain

  4 hours after laparoscopic surgery

Secondary Outcomes (9)

• Assessment of post-operative pain (NRS)

  8 hours, 24 hours and 7 days after laparoscopic surgery

• Nausea

  4 hours, 8 hours, 24 hours and 7 days after laparoscopic surgery

• Post-operative use of piritramide (Dipidolor®)

  Up to 24 hours after laparoscopic surgery

• Assessment of degree of a possible inflammatory reaction

  Through study completion, up to 7 days after laparoscopic surgery

• Assessment of degree of a possible inflammatory reaction

  Through study completion, up to 7 days after laparoscopic surgery

Study Arms (2)

Altered gas (86% CO2, 10% N2O, 4% O2)

EXPERIMENTAL

Surgery with the use of the altered insufflation gas (86% CO2, 10% N2O, 4% O2)

Procedure: Altered gas (86% CO2, 10% N2O, 4% O2)

Standard gas (100% CO2)

ACTIVE COMPARATOR

Surgery with the use of the standardized gas (100% CO2)

Procedure: Standardized gas (100% CO2)

Interventions

Altered gas (86% CO2, 10% N2O, 4% O2) PROCEDURE

Assessment of pain degree after laparoscopic surgery with the altered gas (86% CO2, 10% N2O, 4% O2)

Altered gas (86% CO2, 10% N2O, 4% O2)

Standardized gas (100% CO2) PROCEDURE

Assessement of pain degree after laparoscopic surgery with the standardized gas (100% CO2)

Standard gas (100% CO2)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participant eligibility is based on self-representation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman ≥ 18 years old
• undergoing laparoscopic surgery for endometriosis, uterine myoma's, hysterectomy or colpopexy.

You may not qualify if:

• Women \< 18 years old
• Males
• Pregnancy
• Conditions associated with chronic pain, such as peripheral neuropathy, pathology of the vertebral column and osteo-articular disease.
• Conditions causing acute pain e.g. abdominal trauma

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Björn Stessel, MD, PhD

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Anesthesiologist, MD, PhD

Model Details: A total of 4 conditions will be assessed: endometriosis, myoma, hysterectomy and colpopexy. For every group of patients receiving the altered gas, a group of controls which are patients receiving the standardized gas will be assessed to compare the results in a double-blinded fashion

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 8, 2019
• Study Start: April 1, 2019
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-03

Locations

BE (1)