Clinical trial NCT03201744: Prospective Randomized Trial of Moderate vs Deep Neuromuscular Blockade During Laparoscopic Ventral Hernia Repair
Official title: Prospective Randomized Trial of Moderate vs Deep Neuromuscular Blockade During Laparoscopic Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Ventral
Neuromuscular Blockade
Pneumoperitoneum
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-06-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study aims to assess the effect of different levels of muscle relaxation on the success of low-pressure insufflation, surgical conditions and patient recovery following laparoscopic repair of a ventral hernia (VHR) between 2 and 10cm in diameter. Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation.

Specific Aim 1. Compare two different modes of neuromuscular blockade (moderate and deep) on the ability to maintain low insufflation pressure during laparoscopic VHR. All procedures will start with low-pressure insufflation (8 mm Hg). Surgeon assessment of the conditions will be serially performed during surgery on an established visual scale. If conditions are deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up to 15 mm Hg. Outcome for this specific aim will be the mean insufflation pressure during each procedure, and the ability to perform low-pressure laparoscopic VHR.

Specific Aim 2. Evaluate the success of moderate neuromuscular blockade on the ability to maintain good conditions (visual scale grade 4 or 5) for each. Surgical conditions will be considered successful when scores are maintained at 4 or 5 throughout the duration of the procedure. Outcome for this aim will be the mean score for surgical condition assessment for each procedure, using a previously published surgeon-driven scoring system (score 4-5 will be used as a surrogate of good visualization).

Specific Aim 3. Assess patient recovery with low and high insufflation pressures during laparoscopic VHR. Patient overall satisfaction with recovery, pain level, pain medication requirement, PONV incidence and severity will be assessed in multiple time points following surgery. Outcomes for this aim will be mean pain (visual scale), PONV severity (analogue score) and incidence (binary outcome), and patient satisfaction using the QoR-15 survey. Assessments will be performed at 30 minutes, 1, 12 and 24 hours following surgery.


Eligibility criteria: Inclusion Criteria:

* Patients age 18-75 years old
* Umbilical, ventral, epigastric, spigelian or incisional hernia
* Plan for laparoscopic ventral hernia repair with mesh
* Estimated fascial defect between 2-10 cm in maximum diameter

Exclusion Criteria:

* Allergy to medications delineated in the protocol (muscle blockade, anesthetics, reversal agents)
* Inability to provide informed consent
* Body mass index of 35 or over
* Multiple recurrent hernias (\>1)
* Creatinine clearance \< 30 ml/min (using the Cockcroft-Gault calculation)

Primary outcomes:
measure: Mean insufflation pressure during each procedure as a continuous variable
timeFrame: will be assessed every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair)
Secondary outcomes:
measure: Surgical condition assessment
timeFrame: every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair)
measure: PONV severity (analogue score) and incidence (binary)
timeFrame: it will be assessed at 30 minutes, 1 hour, 12 hours and 24 hours after the completion of laparoscopic ventral hernia repair
measure: Patient satisfaction (QoR-15).
timeFrame: it will be assessed 24 hours after the completion of laparoscopic ventral hernia repair
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Shabana Humayon
state: New York
Study officials:
affiliation: StonyBrook University Hospital
name: Konstantinos Spaniolas, MD
role: PRINCIPAL_INVESTIGATOR
References: