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Completed

NCT Number: NCT03867552

Pain Relief in Laparoscopic Surgery

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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)

Standardized gas (100% CO2)

Procedure

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

Primary outcomes

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

    Time frame: 4 hours after laparoscopic surgery

    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

Secondary outcomes

  1. Assessment of post-operative pain (NRS)

    Time frame: 8 hours, 24 hours and 7 days after laparoscopic surgery

    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

  2. Nausea

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

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

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

    Time frame: Up to 24 hours after laparoscopic surgery

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

  4. Assessment of degree of a possible inflammatory reaction

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

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

  5. Assessment of degree of a possible inflammatory reaction

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

    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

  6. Time to resumption of transit

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

    Time to first flatus and time to first stool

  7. Assessment of quality of Recovery (QOR)

    Time frame: 24 hours and 7 days after laparoscopic surgery

    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")

  8. Assessment of quality of Recovery (QOR)

    Time frame: 24 hours and 7 days after laparoscopic surgery

    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)

  9. Patient satisfaction

    Time frame: 7 days after laparoscopic surgery

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

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2019
Registry last updated
Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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