Pain, PostoperativeNCT03290521
Intraperitoneal Lavage for Reducing Pain in Laparoscopy
A study testing intraperitoneal washing with saline solution and No washing in people with Pain, Postoperative, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
The aim of the present study is to evaluate the role of intraperitoneal washing irrigation with saline solution at the end of laparoscopic hysterectomy or myomectomy in reducing perception of postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- intraperitoneal washing with saline solution and No washing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2018to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients candidates tor hysterectomy, hysterectomy and annessiectomy, laparoscopic myomectomy;
- ECOG Performance Status between 0 and 1;
- ages between 18 and 70 years
- no present or previous systemic neoplastic disease
- signed informed consent to the operation and execution of the intraperitoneal wash procedure.
Who cannot join
- pregnancy,
- pre-existing coagulopathy, neurological or cognitive dysfunction,
- previous or recent pelvic flogosis,
- previous opioid intake for chronic pain,
- previous abdominal surgery,
- previous or current systemic neoplastic disease
Show all 11Show fewer
- concomitant ovarian and cervical gynecological disease,
- intraoperative conversion from laparoscopy to laparotomy ,
- intraoperative complications,
- use of morphine in the postoperative period,
- ECOG Performance Status >1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Intraperitoneal Irrigation and Lavage With Normal Saline for Reduction of Postoperative Pain After Laparoscopic Hysterectomy and Myomectomy: A Randomized Controlled Trial
The aim of the present study is to evaluate the role of intraperitoneal washing irrigation with saline solution at the end of laparoscopic hysterectomy or myomectomy in reducing perception of postoperative pain.
Read the detailed description
Patients will be fully and accurately informed on the type of intervention and will sign a specific informed consent, in accordance with CBM standards, both for the intervention to which the patient will undergo both for the study in question.
Randomization will be performed through a randomized randomization table generated by a computer. Patients will therefore be divided into two groups:
A - Yes Washing (SL) B - No Washing (NL) Prior to surgery, hemoglobin and PCR values will be evaluated in the preoperative.
Prior to the incision, an antibiotic prophylaxis will be performed with cefazoline 2gr intravenously.
The intervention in both groups involves the periombelic cutaneous incision and the sub-umbilical band. Introduction of 10mm led trocar based on open technique. The introduction of optics and CO2 insufflation allows the macroscopic visualization of the endotominal organs. The investigators proceed with the introduction of 3 additional 3-lane trocar accessories in the left iliac fossa, right and overlaid iliac thorax. You will perform a hysterectomy possibly associated with annessiectomy or myomectomy according to the surgical indication. Careful hemostasis is carried out. In the SL group, the washing process is continued. In particular, 1000cc of laced ringer is instilled by changing the position of the patient in Trendelenburg and Anti-Trendelenburg so that the liquid contacts not only the internal surgical wounds but the whole wall of the abdominal cavity. The surgery ends with the closure of the band and the breasts cutaneous. The parameters measured during the operation are: operating time, amount of CO2 injected (L), pneumoperitoneal pressure (mmHg). The operator surgeon is always the same.
In the postoperative period, the following parameters will be evaluated: hemoglobin, white blood cells, PCR, body temperature, recovery of intestinal activity, administration of toradol, paracetamol and possible morphine and postoperative postoperative pain, palpation, cough. The latter is evaluated through tables using the VAS visual scale: patients report the subjective characteristics of perceived postoperative pain by attributing a value of 0 (no pain) to 10 (worse pain than I can imagine). It assesses the occurrence of any complications in post-operative, infection and fever, which may require the patient's exclusion from the study.
- Conditions
- Pain, Postoperative
- Being tested
- intraperitoneal washing with saline solution, No washing
- Keywords
- pain, laparoscopy, washing, intraperitoneal irrigation
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraperitoneal washing with saline solutionProcedure or surgery
intraperitoneal washing at the end of surgery
No washingProcedure or surgery
no washing
| Study group | Role | What they receive |
|---|---|---|
| A - Yes Washing (SL) | Experimental | In this group, the washing process is continued. In particular, 1000cc of laced ringer is instilled by changing the position of the patient in Trendelenburg and Anti-Trendelenburg so that the liquid contacts not only the internal surgical wounds but the whole wall of the abdominal cavity. Receives: Procedure: intraperitoneal washing with saline solution |
| B- No Washing (NL) | Experimental | No washing was performed before the end of surgery Receives: Procedure: No washing |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
to evaluate the postoperative pain using VAS scale
Measured: 17 months
Secondary outcomes (1)
infections
postoperative infections
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start1 Jul 2018
- Primary completion30 Mar 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will therefore be divided into two groups: A - Yes Washing (SL) B - No Washing (NL)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Angioli, Campus Bio-Medico University
- Investigators
- Roberto Angioli, Principal investigator, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290521
- Sponsor's protocol ID
- PAINLESS2812
- Status last verified
- Feb 2021
- First submitted
- 18 Sep 2017
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Use of intraperitoneal washing to reduce postoperative pain in laparoscopy
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Intraperitoneal Irrigation and Lavage With Normal Saline for Reduction of Postoperative Pain After Laparoscopic Hysterectomy and Myomectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03290521
- Acronym / sponsor ID
- PAINLESS2812
- Conditions
- Pain, Postoperative
- Keywords
- pain, laparoscopy, washing, intraperitoneal irrigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to evaluate the role of intraperitoneal washing irrigation with saline solution at the end of laparoscopic hysterectomy or myomectomy in reducing perception of postoperative pain.
Detailed description
Patients will be fully and accurately informed on the type of intervention and will sign a specific informed consent, in accordance with CBM standards, both for the intervention to which the patient will undergo both for the study in question.
Randomization will be performed through a randomized randomization table generated by a computer. Patients will therefore be divided into two groups:
A - Yes Washing (SL) B - No Washing (NL) Prior to surgery, hemoglobin and PCR values will be evaluated in the preoperative.
Prior to the incision, an antibiotic prophylaxis will be performed with cefazoline 2gr intravenously.
The intervention in both groups involves the periombelic cutaneous incision and the sub-umbilical band. Introduction of 10mm led trocar based on open technique. The introduction of optics and CO2 insufflation allows the macroscopic visualization of the endotominal organs. The investigators proceed with the introduction of 3 additional 3-lane trocar accessories in the left iliac fossa, right and overlaid iliac thorax. You will perform a hysterectomy possibly associated with annessiectomy or myomectomy according to the surgical indication. Careful hemostasis is carried out. In the SL group, the washing process is continued. In particular, 1000cc of laced ringer is instilled by changing the position of the patient in Trendelenburg and Anti-Trendelenburg so that the liquid contacts not only the internal surgical wounds but the whole wall of the abdominal cavity. The surgery ends with the closure of the band and the breasts cutaneous. The parameters measured during the operation are: operating time, amount of CO2 injected (L), pneumoperitoneal pressure (mmHg). The operator surgeon is always the same.
In the postoperative period, the following parameters will be evaluated: hemoglobin, white blood cells, PCR, body temperature, recovery of intestinal activity, administration of toradol, paracetamol and possible morphine and postoperative postoperative pain, palpation, cough. The latter is evaluated through tables using the VAS visual scale: patients report the subjective characteristics of perceived postoperative pain by attributing a value of 0 (no pain) to 10 (worse pain than I can imagine). It assesses the occurrence of any complications in post-operative, infection and fever, which may require the patient's exclusion from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will therefore be divided into two groups: A - Yes Washing (SL) B - No Washing (NL)
| Arm | Type | Receives |
|---|---|---|
| A - Yes Washing (SL) | Experimental | Procedure: intraperitoneal washing with saline solutionIn this group, the washing process is continued. In particular, 1000cc of laced ringer is instilled by changing the position of the patient in Trendelenburg and Anti-Trendelenburg so that the liquid contacts not only the internal surgical wounds but the whole wall of the abdominal cavity. |
| B- No Washing (NL) | Experimental | Procedure: No washingNo washing was performed before the end of surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- all patients candidates tor hysterectomy, hysterectomy and annessiectomy, laparoscopic myomectomy;
- ECOG Performance Status between 0 and 1;
- ages between 18 and 70 years
- no present or previous systemic neoplastic disease
- signed informed consent to the operation and execution of the intraperitoneal wash procedure.
Key exclusion criteria (11 listed)
- pregnancy,
- pre-existing coagulopathy, neurological or cognitive dysfunction,
- previous or recent pelvic flogosis,
- previous opioid intake for chronic pain,
- previous abdominal surgery,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraperitoneal washing with saline solutionintraperitoneal washing at the end of surgery | Procedure or surgery | A - Yes Washing (SL) |
| No washingno washing | Procedure or surgery | B- No Washing (NL) |
Primary outcome
pain
Time frame: 17 months
to evaluate the postoperative pain using VAS scale
1 secondary outcome
infections
Time frame: 17 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: No. Use of intraperitoneal washing to reduce postoperative pain in laparoscopy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Angioli principal investigator
Campus Bio-Medico University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraperitoneal washing with saline solution and No washing in people with Pain, Postoperative, run by Campus Bio-Medico University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.