Clinical trial NCT05237700: Steep Trendelenburg With or Without Lithotomy Positioning on the Operating Table.
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Neuropathy
Intraoperative Injury
Intraoperative Complications
Patient Positioning
Operating Table
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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:

1. Identify the incidence of IPNI up to 12 months after surgery.
2. Explore pain, other symptoms, physical function and quality of life up to 12 months after surgery.
3. Explore risk factors associated with IPNI.
4. Explore associations between IPNI and quality of life.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* Preexisting neuropathies.
* Neurological disease.
* Impaired cognitive function.
* Drug misuse.

Primary outcomes:
measure: Neuropathic pain
timeFrame: 3 months
measure: Pain
timeFrame: 3 months
measure: Neuropathic symptoms
timeFrame: 3 months
Secondary outcomes:
measure: Physical function
timeFrame: 12 months
measure: Health related quality of life (Rand 12)
timeFrame: 12 months
Other outcomes:
measure: Multiple symptoms (MSAS)
timeFrame: 12 months
Locations:
Study officials:
References: