Randomised controlled trial comparing the effect of low pressure pneumoperitoneum with deep neuromuscular block versus normal pressure pneumoperitoneum with moderate neuromuscular block during laparoscopic colorectal surgery on early quality of recovery.
Rationale: the laparoscopic approach reduced trauma as compared to open surgery, however, the pressure used to create a PNP with sufficient surgical workspace still leads to significant tissue injury. Prior studies show that the use of low-pressure pneumoperitoneum (PNP) during laparoscopic surgery reduced postoperative pain scores, cumulative opioid consumption and improved bowel function recovery. Deep neuromuscular blockade (NMB) as compared to moderate NMB decreases the amount of intra-abdominal pressure required to achieve similar surgical conditions and enables the use of low-pressure PNP without compromising the quality of the surgical field and patient safety. Therefore, the use of deep NMB with low-pressure PNP could be a significant addition to the conventional Enhanced Recovery After Surgery (ERAS) protocols. Objective: to establish the relationship between the use of low pressure pneumoperitoneum with deep neuromuscular blockade and the early quality of recovery after laparoscopic colorectal surgery. Study design: a multi-center, blinded, randomized controlled clinical trial. Study population: adult individuals scheduled for laparoscopic colorectal surgery with a primary colonic anastomosis. Intervention: participants will be randomly assigned in a 1:1 fashion to either the experimental group (group A): low pressure PNP (8 mmHg) with deep NMB (PTC 1-2) or the control group (group B): normal pressure PNP (12 mmHg) with moderate NMB (TOF count 1-2). Primary endpoint: Quality of recovery score (QoR-40) 24 hours after surgery. Secondary endpoints: QoR-40 score (day 3 and 7 after surgery), McGill pain- and RAND-36 score (1 day before and 3 months after surgery), pain scores, PONV, analgesia use, length of hospital stay, postoperative complications, surgical conditions and time to reach discharge criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
178
Lowering intra-abdominal pressure during laparoscopic surgery
Deep (PTC 1-2) versus moderate (Tof count 1-2) neuromuscular block
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands
Martini general hospital
Groningen, Netherlands
Maxima Medisch Centrum
Veldhoven, Netherlands
Total score on the Quality of Recovery-40 questionnaire
The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200.
Time frame: 24 hours after surgery
Total score on the Quality of Recovery-40 questionnaire
The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200.
Time frame: Day 3 and day 7 after surgery
McGill pain Questionnaire
Validated questionnaire for the assessment of quality and intensity of pain
Time frame: Upon admission and 3 months after surgery
RAND-36 general health questionnaire
Validated patient-reported survey of health
Time frame: Upon admission and 3 months after surgery
Pain scores
Pain at rest and pain upon movement (NRS 0-10), is pain acceptable yes or no, referred shoulder pain yes or no?
Time frame: 1, 8, 24, and 72 hours after surgery
Post-operative nausea and vomiting (PONV)
NRS 0-10
Time frame: 1, 8, 24 and 72 hours after surgery
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Cumulative use of analgesics and anti-emetics
Total dose of opiates, other analgesics and anti-emetic drugs
Time frame: 1, 8, 24 and 72 hours after surgery
Length of hospital stay
Total number of days from admission to discharge after surgery (not including readmission)
Time frame: From date of admission until date of discharge from the hospital (usually several days), assessed up to 3 months.
Surgical conditions
Rating of the surgical conditions with the Leiden Surgical Rating Scale (L-SRS). The L-SRS is scored by the surgeon and ranges from 1-5 for quality of the surgical field. A score of 5 means optimal conditions: a wide laparoscopic field with no patient movements or muscle contractions, 1 means extremely poor conditions: the surgeon is unable to obtain a visible laparoscopic field because of inadequate muscle relaxation.
Time frame: Intraoperative: after introduction of the trocars and every 15 minutes until the end of the pneumoperitoneum.
Intraoperative complications
Complications during surgery graded according to the Clavien-Dindo classification
Time frame: During surgery
Postoperative complications
Postoperative complications
Time frame: Up to 3 months after surgery
Time to reach discharge criteria
Number of days to reach the following criteria after surgery: adequate pain control with oral medication, passage of flatus or defecation, intake of solid food tolerated, patient is mobilized and independent and patient accepts discharge.
Time frame: From date of surgery until date of actual discharge from the hospital (usually several days), assessed up to 3 months.