Pain, Postoperative, Surgery
Conditions
Keywords
post-operative pain, recovery, laparoscopy, nitrous oxide
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.
Interventions
PROCEDUREAltered gas (86% CO2, 10% N2O, 4% O2)
Assessment of pain degree after laparoscopic surgery with the altered gas (86% CO2, 10% N2O, 4% O2)
PROCEDUREStandardized gas (100% CO2)
Assessement of pain degree after laparoscopic surgery with the standardized gas (100% CO2)
Sponsors
Jessa Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention 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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: body temperature will be measured in °C in order to investigate fever |
| 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 |
| Assessment of quality of Recovery (QOR) | 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) |
| 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 |
| Time to resumption of transit | Through study completion, up to 7 days after laparoscopic surgery | Time to first flatus and time to first stool |
Countries
Belgium
Outcome results
None listed