Pain Relief in Laparoscopic Surgery

Study Overview
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Brief Summary
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Pain relief after laparoscopic surgery with the use of an altered gas.

Detailed Description
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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.

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

Conditions
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Pain, Postoperative, Surgery

Intervention / Treatment
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* Procedure: Altered gas (86% CO2, 10% N2O, 4% O2)
* Procedure: Standardized gas (100% CO2)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Altered gas (86% CO2, 10% N2O, 4% O2)<br>Surgery with the use of the altered insufflation gas (86% CO2, 10% N2O, 4% O2) | Procedure: Altered gas (86% CO2, 10% N2O, 4% O2)<br>* Assessment of pain degree after laparoscopic surgery with the altered gas (86% CO2, 10% N2O, 4% O2)<br>|
| Active Comparator: Standard gas (100% CO2)<br>Surgery with the use of the standardized gas (100% CO2) | Procedure: Standardized gas (100% CO2)<br>* Assessement of pain degree after laparoscopic surgery with the standardized gas (100% CO2)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 8 hours, 24 hours and 7 days after laparoscopic surgery | 
| Nausea | Assessment of nausea at different time points after surgery (yes/no) | 4 hours, 8 hours, 24 hours and 7 days after laparoscopic surgery | 
| 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 | Up to 24 hours after laparoscopic surgery | 
| 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 | Through study completion, up to 7 days after laparoscopic surgery | 
| 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 | Through study completion, up to 7 days after laparoscopic surgery | 
| Time to resumption of transit | Time to first flatus and time to first stool | Through study completion, up to 7 days after laparoscopic surgery | 
| 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) | 24 hours and 7 days after laparoscopic surgery | 
| 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) | 24 hours and 7 days after laparoscopic surgery | 
| Patient satisfaction | Assessement of patient satisfaction via a seven-point Likert scale, where 1 means extremely unsatisfied and 7 means extremely satisfied | 7 days after laparoscopic surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-operative pain, recovery, laparoscopy, nitrous oxide