Peripheral NeuropathyNCT05237700
Steep Trendelenburg With or Without Lithotomy Positioning on the Operating Table.
An observational study of Peripheral Neuropathy and Intraoperative Injury, run by Oslo University Hospital.
Trial summary
Robotic assisted laparoscopic and laparoscopic gynecological, colon-rectal and urological surgical procedures require that patients be placed in steep Trendelenburg positioning with or without lithotomy on operating table. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy, Intraoperative Injury, Intraoperative Complications
- What is being tested?
- Patient positioning on operating table
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Dec 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted at three of the locations of Oslo University Hospital (OUS), Radium-, Ullevål- and Aker Hospital. We will include 500 patients undergoing elective robotic-assisted or laparoscopic urological, gynecologic and gastroenterological surgery in steep Trendelenburg with or without lithotomy positioning.
Who may be able to join
- Above 18 years.
- Robotic assisted surgery and laparoscopic surgery (urological, gynecologic, gastroenterological)
- Trendelenburg with or without lithotomy positioning on operating table.
- Planned room time > 1.5 hours.
- Speak and understand Norwegian.
- Cooperate (clinical examination).
Who cannot join
- Preexisting neuropathies.
- Neurological disease.
- Impaired cognitive function.
- Drug misuse.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Symptoms, Functional Status and Quality of Life in Patients Undergoing Robotic-assisted and Laparoscopic Surgery in Steep Trendelenburg With or Without Lithotomy Positioning on the Operating Table.
Robotic assisted laparoscopic and laparoscopic gynecological, colon-rectal and urological surgical procedures require that patients be placed in steep Trendelenburg positioning with or without lithotomy on operating table. Steep Trendelenburg positioning is a variation of supine positioning in which the patient lies face up with the head and body tilted 250-450 downwards. In lithotomy position the legs are placed in stirrups and knees bent flexing the leg on the operating table. Lithotomy position can be graded in four levels according to what access the surgeon needs. The arms are tucked and padded parallel to the body, or the arms left on an arm board at an angel of less 900. Intraoperative peripheral nerve injury (IPNI) may follow incorrect positioning, inadequate fixation, or prolonged time in positioning. IPNI is defined as new (within 48 h) sensory and/or motor deficits and occurs following a combination of stretch, ischemia and/or compression during surgery and the injuries are either temporary or permanent. In a systematic review we found that IPNI was related to lithotomy positioning with steep Trendelenburg in upper and lower extremity and the incidence of IPNI ranges from 0.16% to 10 %. IPNI after patient positioning on operating table has been described to result in pain and other symptoms as numbness, weakness, and tingling. As demonstrated in our systematic review many of the patients with IPNI did not report pain, which also supported in a recent review. In addition, our systematic review showed that the symptoms appeared immediately after surgical procedures and usually subside within three months. The systematic review also demonstrates that a few patients continue to have pain or/and other symptoms of IPNI up to one year following the surgery. Furthermore, previous studies have demonstrated that pain intensity and duration of pain influence daily activities and quality of life negatively.
Positioning of the patients on operating table is a teamwork where the operating room nurse (ORN) has a pivotal role in order to protect the patients from experiencing injuries due to e.g. nerve compression and compromised circulation. The purpose of this study is to increase the knowledge of IPNI related to positioning in patients undergoing robotic-assisted laparoscopic surgery and laparoscopic surgery. As IPNI is an unclear phenomenon that can be difficult to diagnose, we want to identify pain and other symptoms immediately after surgery that might have an impact on development of IPNI. Several studies have reported persistent pain after surgery like neuropathic pain and that neuropathic pain occur soon after nerve lesion. To get at a broader picture of IPNI we want to explore pain and other symptoms and to characterize how these symptoms might change, and to identify risk factors associated with IPNI. Therefore, the aims of the present study are:
- Identify the incidence of IPNI up to 12 months after surgery.
- Explore pain, other symptoms, physical function and quality of life up to 12 months after surgery.
- Explore risk factors associated with IPNI.
- Explore associations between IPNI and quality of life.
- Conditions
- Peripheral Neuropathy, Intraoperative Injury, Intraoperative Complications, Patient Positioning, Operating Table
- Being tested
- Patient positioning on operating table
- Medical subject headings
- Peripheral Nervous System Diseases, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient positioning on operating tableOther
The patients are either positioned in Trendelenburg with lithotomy positioning or in Trendelenburg without lithotomy positioning on the operating table when undergoing robotic assisted laparoscopic surgery or laparoscopic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Trendelenburg with lithotomy positioning on the operating table. | The patient is positioned in Trendelenburg with lithotomy positioning on the operating table. Receives: Other: Patient positioning on operating table | |
| Trendelenburg without lithotomy positioning on the operating table. | The patient is positioned in Trendelenburg without lithotomy positioning on the operating table. Receives: Other: Patient positioning on operating table |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic pain
Douleur Neuropathies (DN4) will be used to evaluate neuropathic pain. DN4 is a validated tool to screen the neuropathic origin of pain. It includes three items about the type of pain (burning/painful cold/electric shock), four items about the associated symptoms (tingling/pins and needles/numbness/itching), two about the existence of numbness in painful area (on contact/on pinching), and one about initiation or enhancement of pain rubbing. Three or more positive answers on the seven questions are defined as neuropathic pain. At baseline a study nurse will help the patients to complete the questionnaire. At follow up, for use in this study the questions are adapted for completion by the patients.
Measured: 3 months
Pain
Brief pain inventory (BPI) will be used to measure pain occurrence, pain intensity, pain interference with function and pain relieve. Occurrence is examined using one item where the patients' ticked yes or no if they are generally bothered by pain. Three items measure pain intensity (pain now, worst pain and average pain) and seven items' measures pain interference with functioning (i.e., daily activity, mood, walking ability, normal work, sleep, enjoyment of life, relations with others). The items are scored on an 11-point numeric rating scale from 0-10. The BPI has been reported to be sensitive to change for pain intensity, and a change of two units on the 11-point scale is considered clinically significant. The BPI has been established as a reliable and valid measure of pain in a Norwegian sample.
Measured: 3 months
Neuropathic symptoms
It is developed a study specific questionnaire about neuropathic symptoms (i.e., burning, tingling, numbness, electric shocks) as a supplement to DN4. It is also designed questions to reveal if the patients have reduced muscular force or reduced sensibility in the extremities.
Measured: 3 months
Secondary outcomes (2)
Physical function
Oswestry Disability Index (ODI) will be used to measure physical function related to pain. The ODI contains 10 items concerning intensity of pain (i.e., lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality and ability to travel). Each item is scored on a 6-point scale, with a sum score ranging from 0 (no limitation) to 100 (maximal limitation). The version 2.0 is recommended for general use, is a modification of the original ODI. ODI is a reliable and valid tool and has been translated and adapted for Norwegian patients.
Measured: 12 months
Health related quality of life (Rand 12)
Rand 12 (SF-12 version 1) consists of 12 items; each scored on a 6-point Likert scale. The items assess eight health concepts (i.e., physical functioning, role-physical, bodily pain, general health, energy/fatigue, social functioning, role-emotional and mental health) that comprise a physical component summary (PCS) score and a mental component summary (MCS) score. It is extensively used and validated for many patient groups as well as the general population.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study startFeb 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Signe Berit Bentsen, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237700
- Sponsor's protocol ID
- 104764
- Status last verified
- Feb 2022
- First submitted
- 20 Jan 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptoms, Functional Status and Quality of Life in Patients Undergoing Robotic-assisted and Laparoscopic Surgery in Steep Trendelenburg With or Without Lithotomy Positioning on the Operating Table.
- ClinicalTrials.gov ID
- NCT05237700
- Acronym / sponsor ID
- 104764
- Conditions
- Peripheral Neuropathy, Intraoperative Injury, Intraoperative Complications, Patient Positioning, Operating Table
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Feb 2022 (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.
Robotic assisted laparoscopic and laparoscopic gynecological, colon-rectal and urological surgical procedures require that patients be placed in steep Trendelenburg positioning with or without lithotomy on operating table. Steep Trendelenburg positioning is a variation of supine positioning in which the patient lies face up with the head and body tilted 250-450 downwards. In lithotomy position the legs are placed in stirrups and knees bent flexing the leg on the operating table. Lithotomy position can be graded in four levels according to what access the surgeon needs. The arms are tucked and padded parallel to the body, or the arms left on an arm board at an angel of less 900. Intraoperative peripheral nerve injury (IPNI) may follow incorrect positioning, inadequate fixation, or prolonged time in positioning. IPNI is defined as new (within 48 h) sensory and/or motor deficits and occurs following a combination of stretch, ischemia and/or compression during surgery and the injuries are either temporary or permanent. In a systematic review we found that IPNI was related to lithotomy positioning with steep Trendelenburg in upper and lower extremity and the incidence of IPNI ranges from 0.16% to 10 %. IPNI after patient positioning on operating table has been described to result in pain and other symptoms as numbness, weakness, and tingling. As demonstrated in our systematic review many of the patients with IPNI did not report pain, which also supported in a recent review. In addition, our systematic review showed that the symptoms appeared immediately after surgical procedures and usually subside within three months. The systematic review also demonstrates that a few patients continue to have pain or/and other symptoms of IPNI up to one year following the surgery. Furthermore, previous studies have demonstrated that pain intensity and duration of pain influence daily activities and quality of life negatively.
Positioning of the patients on operating table is a teamwork where the operating room nurse (ORN) has a pivotal role in order to protect the patients from experiencing injuries due to e.g. nerve compression and compromised circulation. The purpose of this study is to increase the knowledge of IPNI related to positioning in patients undergoing robotic-assisted laparoscopic surgery and laparoscopic surgery. As IPNI is an unclear phenomenon that can be difficult to diagnose, we want to identify pain and other symptoms immediately after surgery that might have an impact on development of IPNI. Several studies have reported persistent pain after surgery like neuropathic pain and that neuropathic pain occur soon after nerve lesion. To get at a broader picture of IPNI we want to explore pain and other symptoms and to characterize how these symptoms might change, and to identify risk factors associated with IPNI. Therefore, the aims of the present study are:
- Identify the incidence of IPNI up to 12 months after surgery.
- Explore pain, other symptoms, physical function and quality of life up to 12 months after surgery.
- Explore risk factors associated with IPNI.
- Explore associations between IPNI and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trendelenburg with lithotomy positioning on the operating table. | – | Other: Patient positioning on operating tableThe patient is positioned in Trendelenburg with lithotomy positioning on the operating table. |
| Trendelenburg without lithotomy positioning on the operating table. | – | Other: Patient positioning on operating tableThe patient is positioned in Trendelenburg without lithotomy positioning on the operating table. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted at three of the locations of Oslo University Hospital (OUS), Radium-, Ullevål- and Aker Hospital. We will include 500 patients undergoing elective robotic-assisted or laparoscopic urological, gynecologic and gastroenterological surgery in steep Trendelenburg with or without lithotomy positioning.
Key inclusion criteria (6 listed)
- Above 18 years.
- Robotic assisted surgery and laparoscopic surgery (urological, gynecologic, gastroenterological)
- Trendelenburg with or without lithotomy positioning on operating table.
- Planned room time > 1.5 hours.
- Speak and understand Norwegian.
Key exclusion criteria (4 listed)
- Preexisting neuropathies.
- Neurological disease.
- Impaired cognitive function.
- Drug misuse.
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 |
|---|---|---|
| Patient positioning on operating tableThe patients are either positioned in Trendelenburg with lithotomy positioning or in Trendelenburg without lithotomy positioning on the operating table when undergoing robotic assisted laparoscopic surgery or laparoscopic surgery. | Other | Trendelenburg with lithotomy positioning on the operating table., Trendelenburg without lithotomy positioning on the operating table. |
Primary outcome
Neuropathic pain
Time frame: 3 months
Douleur Neuropathies (DN4) will be used to evaluate neuropathic pain. DN4 is a validated tool to screen the neuropathic origin of pain. It includes three items about the type of pain (burning/painful cold/electric shock), four items about the associated symptoms (tingling/pins and needles/numbness/itching), two about the existence of numbness in painful area (on contact/on pinching), and one about initiation or enhancement of pain rubbing. Three or more positive answers on the seven questions are defined as neuropathic pain. At baseline a study nurse will help the patients to complete the questionnaire. At follow up, for use in this study the questions are adapted for completion by the patients.
Pain
Time frame: 3 months
Brief pain inventory (BPI) will be used to measure pain occurrence, pain intensity, pain interference with function and pain relieve. Occurrence is examined using one item where the patients' ticked yes or no if they are generally bothered by pain. Three items measure pain intensity (pain now, worst pain and average pain) and seven items' measures pain interference with functioning (i.e., daily activity, mood, walking ability, normal work, sleep, enjoyment of life, relations with others). The items are scored on an 11-point numeric rating scale from 0-10. The BPI has been reported to be sensitive to change for pain intensity, and a change of two units on the 11-point scale is considered clinically significant. The BPI has been established as a reliable and valid measure of pain in a Norwegian sample.
Neuropathic symptoms
Time frame: 3 months
It is developed a study specific questionnaire about neuropathic symptoms (i.e., burning, tingling, numbness, electric shocks) as a supplement to DN4. It is also designed questions to reveal if the patients have reduced muscular force or reduced sensibility in the extremities.
2 secondary outcomes
Physical function
Time frame: 12 months
Health related quality of life (Rand 12)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
Related trials for Peripheral Neuropathy
RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy, Diabetes Complication
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
Recruiting
Effect of TMS on Neuropathic Pain for Patients With Spinal Cord Injury
Spinal Cord Injury, Neuropathic Pain
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Not yet recruiting
Ultrasound-Guided Electrical Dry Needling for Chronic Cervical Radiculopathy: A Randomized Controlled Trial
Cervical Radiculopathy
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Neuropathy and Intraoperative Injury, run by Oslo University Hospital.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benedikte Bjøro (0047 90176072, berabj@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic pain (time frame: 3 months). The study lists 3 primary outcomes in all. 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 14 Feb 2022.