Clinical trial NCT03867552: Pain Relief in Laparoscopic Surgery
Official title: Pain Relief in Laparoscopic Surgery - to Relief Pain After Laparoscopic Surgery With the Use of a Altered Gas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Surgery
Keywords: post-operative pain
recovery
laparoscopy
nitrous oxide
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of post-operative pain with an 11-point numerical rating score (NRS)
timeFrame: 4 hours after laparoscopic surgery
Secondary outcomes:
measure: Assessment of post-operative pain (NRS)
timeFrame: 8 hours, 24 hours and 7 days after laparoscopic surgery
measure: Nausea
timeFrame: 4 hours, 8 hours, 24 hours and 7 days after laparoscopic surgery
measure: Post-operative use of piritramide (Dipidolor®)
timeFrame: Up to 24 hours after laparoscopic surgery
measure: Assessment of degree of a possible inflammatory reaction
timeFrame: Through study completion, up to 7 days after laparoscopic surgery
measure: Assessment of degree of a possible inflammatory reaction
timeFrame: Through study completion, up to 7 days after laparoscopic surgery
measure: Time to resumption of transit
timeFrame: Through study completion, up to 7 days after laparoscopic surgery
measure: Assessment of quality of Recovery (QOR)
timeFrame: 24 hours and 7 days after laparoscopic surgery
measure: Assessment of quality of Recovery (QOR)
timeFrame: 24 hours and 7 days after laparoscopic surgery
measure: Patient satisfaction
timeFrame: 7 days after laparoscopic surgery
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Jessa Hospital
name: Björn Stessel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: