Pain relief after laparoscopic surgery with the use of an altered gas.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
74
Assessment of pain degree after laparoscopic surgery with the altered gas (86% CO2, 10% N2O, 4% O2)
Assessement of pain degree after laparoscopic surgery with the standardized gas (100% CO2)
Jessa Hospital
Hasselt, Limburg, Belgium
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
Time frame: 4 hours after laparoscopic surgery
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
Time frame: 8 hours, 24 hours and 7 days after laparoscopic surgery
Nausea
Assessment of nausea at different time points after surgery (yes/no)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, up to 7 days after laparoscopic surgery
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Time to resumption of transit
Time to first flatus and time to first stool
Time frame: 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")
Time frame: 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)
Time frame: 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
Time frame: 7 days after laparoscopic surgery