Pain Relief in Laparoscopic Surgery
- Conditions
- Pain, PostoperativeSurgery
- Interventions
- Procedure: Altered gas (86% CO2, 10% N2O, 4% O2)Procedure: Standardized gas (100% CO2)
- Registration Number
- NCT03867552
- Lead Sponsor
- Jessa Hospital
- Brief Summary
Pain relief after laparoscopic surgery with the use of an altered gas.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 74
- Woman ≥ 18 years old
- undergoing laparoscopic surgery for endometriosis, uterine myoma's, hysterectomy or colpopexy.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Altered gas (86% CO2, 10% N2O, 4% O2) Altered gas (86% CO2, 10% N2O, 4% O2) Surgery with the use of the altered insufflation gas (86% CO2, 10% N2O, 4% O2) Standard gas (100% CO2) Standardized gas (100% CO2) Surgery with the use of the standardized gas (100% CO2)
- Primary Outcome Measures
Name Time Method Assessment of post-operative pain with an 11-point numerical rating score (NRS) 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 Outcome Measures
Name Time Method Assessment of post-operative pain (NRS) 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
Nausea 4 hours, 8 hours, 24 hours and 7 days after laparoscopic surgery Assessment of nausea at different time points after surgery (yes/no)
Post-operative use of piritramide (Dipidolor®) 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
Assessment of degree of a possible inflammatory reaction 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
Time to resumption of transit Through study completion, up to 7 days after laparoscopic surgery Time to first flatus and time to first stool
Assessment of quality of Recovery (QOR) 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)
Patient satisfaction 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
Trial Locations
- Locations (1)
Jessa Hospital
🇧🇪Hasselt, Limburg, Belgium