Pain Relief in Laparoscopic Surgery

Pain Relief in Laparoscopic Surgery - to Relief Pain After Laparoscopic Surgery With the Use of a Altered Gas

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Surgery
• Intervention / Treatment: Procedure: Altered gas (86% CO2, 10% N2O, 4% O2); Procedure: Standardized gas (100% CO2)

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Jessa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Altered gas (86% CO2, 10% N2O, 4% O2); Surgery with the use of the altered insufflation gas (86% CO2, 10% N2O, 4% O2)	Procedure: Altered gas (86% CO2, 10% N2O, 4% O2); Assessment of pain degree after laparoscopic surgery with the altered gas (86% CO2, 10% N2O, 4% O2)
Active Comparator: Standard gas (100% CO2); Surgery with the use of the standardized gas (100% CO2)	Procedure: Standardized gas (100% CO2); Assessement of pain degree after laparoscopic surgery with the standardized gas (100% CO2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 hours after laparoscopic surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 hours, 24 hours and 7 days after laparoscopic surgery
Nausea	Assessment of nausea at different time points after surgery (yes/no)	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	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	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	Through study completion, up to 7 days after laparoscopic surgery
Time to resumption of transit	Time to first flatus and time to first stool	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")	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)	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	7 days after laparoscopic surgery

Collaborators and Investigators

• Sponsor: Jessa Hospital
• Investigators: Principal Investigator: Björn Stessel, MD, PhD, Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): February 17, 2022
• Study Completion (Actual): February 17, 2022

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (Actual): March 8, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: recovery; laparoscopy; nitrous oxide; post-operative pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 19.08/Gynaeco19.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No