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Pain, PostoperativeNCT03867552

Pain Relief in Laparoscopic Surgery

A study testing Altered gas (86% CO2, 10% N2O, 4% O2) and Standardized gas (100% CO2) in people with Pain, Postoperative and Surgery, run by Jessa Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pain relief after laparoscopic surgery with the use of an altered gas. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pain, Postoperative, Surgery
What is being tested?
Altered gas (86% CO2, 10% N2O, 4% O2) and Standardized gas (100% CO2)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteBelgium
Study dates
1 Apr 2019to 17 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Jessa Hospital

    Hasselt, Limburg, 3500

Other trials in Belgium

About this study

Official title: Pain Relief in Laparoscopic Surgery - to Relief Pain After Laparoscopic Surgery With the Use of a Altered Gas

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

Read the detailed description

Pain after laparoscopic surgery remains an important concern in the treatment of endometriosis or other gynaecologic laparoscopic surgery. Several trials have demonstrated that the use of an altered insufflation gas (10 % nitrous oxide + 4% oxygen + 86% carbon dioxide) reduces pain. It also decreases inflammation and adhesion formation as a surplus.

With this mono-center, investigator initiated, double-blinded, randomized controlled superiority trial, the investigators want to demonstrate a reduced postoperative pain and peritoneal inflammatory reaction following peritoneal conditioning with an altered insufflation gas compared to the standard carbon dioxide (100% CO2) insufflation gas. Therefore, women undergoing laparoscopic (gynaecological) surgery with an estimated surgical time of >60 minutes will be asked to participate in this trial. Baseline characteristics will be assessed, including the patients' age, body mass index, medial history, American Society of Anesthesiologist Classification (ASA classification), work status, highest level of education, fear for the surgical procedure (using an 8-item surgical fear questionnaire), pre-operative pain (using a Numerical Rating Scale (NRS) were 0= no pain and 10= worst pain imaginable) both in resting position and in an active position), expected pain (NRS), baseline quality of recovery (QOR) (using the 1-item Global Surgical Recovery (GSR) index (3) and the Functional Recovery Index (FRI) (4)) as well as baseline quality of Life (QOL), using the 5-dimensional European Quality of Life (EQ-5D) questionnaire.

Being tested
Altered gas (86% CO2, 10% N2O, 4% O2), Standardized gas (100% CO2)
Keywords
post-operative pain, recovery, laparoscopy, nitrous oxide
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Altered gas (86% CO2, 10% N2O, 4% O2)Procedure or surgery

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

  • Standardized gas (100% CO2)Procedure or surgery

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

Study groups in NCT03867552
Study groupRoleWhat they receive
Altered gas (86% CO2, 10% N2O, 4% O2)ExperimentalSurgery with the use of the altered insufflation gas (86% CO2, 10% N2O, 4% O2)
Receives: Procedure: Altered gas (86% CO2, 10% N2O, 4% O2)
Standard gas (100% CO2)Active comparatorSurgery with the use of the standardized gas (100% CO2)
Receives: Procedure: Standardized gas (100% CO2)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 hours after laparoscopic surgery

Secondary outcomes (9)

  1. Assessment of post-operative pain (NRS)

    Assessement of pain at different time points after surgery with an 11-point numerical rating score NRS, where 0 means no pain and 10 means worst imaginable pain

    Measured: 8 hours, 24 hours and 7 days after laparoscopic surgery

  2. Nausea

    Assessment of nausea at different time points after surgery (yes/no)

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

  3. Post-operative use of piritramide (Dipidolor®)

    Dose of piritramide after laparoscopic surgery in patients treated with altered gas compared to patients treated with the standard gas

    Measured: Up to 24 hours after laparoscopic surgery

  4. Assessment of degree of a possible inflammatory reaction

    Assessed via standard medical practice: body temperature will be measured in °C in order to investigate fever

    Measured: Through study completion, up to 7 days after laparoscopic surgery

  5. Assessment of degree of a possible inflammatory reaction

    Assessed via standard medical practice: potential blood samples measuring C-Reactive Protein (in mg/l) which is a measure for inflammation can be measured if needed throughout the study

    Measured: Through study completion, up to 7 days after laparoscopic surgery

  6. Time to resumption of transit

    Time to first flatus and time to first stool

    Measured: Through study completion, up to 7 days after laparoscopic surgery

  7. Assessment of quality of Recovery (QOR)

    Assessment of QOR using the 1-item Global Surgical Recovery (GSR) index which represents a single question about the extent to which patients considered themselves to be recovered from surgery ("if 100% recovery means the participants health is back to the same level as it was before the surgery, what percentage of recovery is the participant at now")

    Measured: 24 hours and 7 days after laparoscopic surgery

  8. Assessment of quality of Recovery (QOR)

    Assessment of QOR using the Functional Recovery Index (FRI) questionnaire which assesses functional QOL on an NRS scale and covers 14 items grouped under three factors (pain and social activity, lower limb activity and general physical activity)

    Measured: 24 hours and 7 days after laparoscopic surgery

  9. Patient satisfaction

    Assessement of patient satisfaction via a seven-point Likert scale, where 1 means extremely unsatisfied and 7 means extremely satisfied

    Measured: 7 days after laparoscopic surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2019
  2. Study start1 Apr 2019
  3. Primary completion17 Feb 2022
  4. Study completion17 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03867552
Sponsor's protocol ID
19.08/Gynaeco19.01
Status last verified
Mar 2022
First submitted
28 Feb 2019
Last updated
14 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Altered gas (86% CO2, 10% N2O, 4% O2) and Standardized gas (100% CO2) in people with Pain, Postoperative and Surgery, run by Jessa Hospital at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of post-operative pain with an 11-point numerical rating score (NRS) (time frame: 4 hours after laparoscopic surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03867552.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.

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