Pain Relief in Laparoscopic Surgery

Jessa Hospital

Status: Completed

Conditions: Surgery; Pain, Postoperative

Treatments: Procedure: Standardized gas (100% CO2); Procedure: Altered gas (86% CO2, 10% N2O, 4% O2)

Study type: Interventional

Funder types: Other

Identifiers

NCT03867552

19.08/Gynaeco19.01

Details and patient eligibility

About

Pain relief after laparoscopic surgery with the use of an altered gas.

Full 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.

Enrollment: 74 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Altered gas (86% CO2, 10% N2O, 4% O2)

Experimental group

Description:

Surgery with the use of the altered insufflation gas (86% CO2, 10% N2O, 4% O2)

Treatment:

Procedure: Altered gas (86% CO2, 10% N2O, 4% O2)

Standard gas (100% CO2)

Active Comparator group

Description:

Surgery with the use of the standardized gas (100% CO2)

Treatment:

Procedure: Standardized gas (100% CO2)