Pain Relief in Laparoscopic Surgery

• Sponsor: Jessa Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03867552
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Arms: 2
• Actual Duration (Months): 34.6
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative; Surgery	Procedure: Altered gas (86% CO2, 10% N2O, 4% O2); Procedure: Standardized gas (100% CO2)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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 fashionA 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
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Pain Relief in Laparoscopic Surgery - to Relief Pain After Laparoscopic Surgery With the Use of a Altered Gas
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: Feb 17, 2022
• Actual Study Completion Date: Feb 17, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Nausea [4 hours, 8 hours, 24 hours and 7 days after laparoscopic surgery]

   Assessment of nausea at different time points after surgery (yes/no)

3. 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

4. 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

5. 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

6. Time to resumption of transit [Through study completion, up to 7 days after laparoscopic surgery]

   Time to first flatus and time to first stool

7. 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")

8. 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)

9. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jessa Hospital	Hasselt	Limburg	Belgium	3500

Sponsors and Collaborators

• Jessa Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stessel Björn, Principal Investigator, Anesthesiologist, MD, PhD, Jessa Hospital
• ClinicalTrials.gov Identifier: NCT03867552
• Other Study ID Numbers: 19.08/Gynaeco19.01
• First Posted: Mar 8, 2019
• Last Update Posted: Mar 14, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Stessel Björn, Principal Investigator, Anesthesiologist, MD, PhD, Jessa Hospital: post-operative pain; recovery; laparoscopy; nitrous oxide
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Mar 14, 2022