Low-pressure pneumoperitoneum with deep neuromuscular blockade versus standard pressure pneumoperitoneum in patients undergoing laparoscopic cholecystectomy for gallstone disease: a non-inferiority randomized control trial.

BACKGROUND: Low-pressure pneumoperitoneum (LPP) is an attempt at improving laparoscopic surgery. However, it has the issue of poor working space for which deep neuromuscular blockade (NMB) may be a solution. There is a lack of literature comparing LPP with deep NMB to standard pressure pneumoperitoneum (SPP) with moderate NMB. METHODOLOGY: This was a single institutional prospective non-inferiority RCT, with permuted block randomization of subjects into group A and B [Group A: LPP; 8-10 mmHg with deep NMB [ Train of Four count (TOF): 0, Post Tetanic Count (PTC): 1-2] and Group B: SPP; 12-14 mmHg with moderate NMB]. The level of NMB was monitored with neuromuscular monitor with TOF count and PTC. Cisatracurium infusion was used for continuous deep NMB in group A. Primary outcome measures were the surgeon satisfaction score and the time for completion of the procedure. Secondarily important clinical outcomes were also reported. RESULTS: Of the 222 patients screened, 181 participants were enrolled [F: 138 (76.2%); M: 43 (23.8%); Group A n = 90, Group B n = 91]. Statistically similar surgeon satisfaction scores (26.1 ± 3.7 vs 26.4 ± 3.4; p = 0.52) and time for completion (55.2 ± 23.4 vs 52.5 ± 24.9 min; p = 0.46) were noted respectively in groups A and B. On both intention-to-treat and per-protocol analysis it was found that group A was non-inferior to group B in terms of total surgeon satisfaction score, however, non-inferiority was not proven for time for completion of surgery. Mean pain scores and incidence of shoulder pain were statistically similar up-to 7 days of follow-up in both groups. 4 (4.4%) patients in group B and 2 (2.2%) in group A had bradycardia (p = 0.4). Four (4.4%) cases of group A were converted to group B. One case of group B converted to open surgery. Bile spills and gallbladder perforations were comparable. CONCLUSION: LPP with deep NMB is non-inferior to SPP with moderate NMB in terms of surgeon satisfaction score but not in terms of time required to complete the procedure. Clinical outcomes and safety profile are similar in both groups. However, it could be marginally costlier to use LPP with deep NMB.

Comparison of inflammatory markers in low-pressure pneumoperitoneum with deep neuromuscular block versus standard pressure pneumoperitoneum among patients undergoing laparoscopic cholecystectomy for gallstone disease: a randomized control trial.

BACKGROUND: Low-pressure pneumoperitoneum (LPP) is an attempt to improve laparoscopic surgery. Lower pressure causes lesser inflammation and better hemodynamics. There is a lack of literature comparing inflammatory markers in LPP with deep NMB to standard pressure pneumoperitoneum (SPP) with moderate NMB in laparoscopic cholecystectomy. METHODOLOGY: This was a single institutional prospective randomized control trial. Participants included all patients undergoing laparoscopic cholecystectomy for symptomatic gall stone disease. Participants were divided into 2 groups group A and B. Group A-Low-pressure group in which pneumoperitoneum pressure was kept low (8-10 mmHg) with deep Neuromuscular blockade (NMB) and Group B-Normal pressure group (12-14 mmHg) with moderate NMB. A convenience sample size of 80 with 40 in each group was selected. Lab investigations like CBC, LFT, RFT and serum IL-1, IL-6, IL-17, TNF alpha levels were measured at base line and 24 h after surgery and compared using appropriate statistical tests. Other parameters like length of hospital stay, post-operative pain score, conversion rate (low-pressure to standard pressure), and complications were also compared. RESULTS: Eighty participants were analysed with 40 in each group. Baseline characteristics and investigations were statistically similar. Difference (post-operative-pre-operative) of inflammatory markers were compared between both groups. Numerically there was a slightly higher rise in most of the inflammatory markers (TLC, ESR, CRP, IL-6, TNFα) in Group B compared to Group A but not statistically significant. Albumin showed significant fall (p < 0.001) in Group B compared to Group A. Post-operative pain was also significantly less (p < 0.001) in Group A compared to Group B at 6 h and 24 h. There were no differences in length of hospital stay and incidence of complications. There was no conversion from low-pressure to standard pressure. CONCLUSION: Laparoscopic cholecystectomy performed under low-pressure pneumoperitoneum with deep NMB may have lesser inflammation and lesser post-operative pain compared to standard pressure pneumoperitoneum with moderate NMB. Future studies with larger sample size need to be designed to support these findings.

The impact of AirSeal® on complications and pain management during robotic-assisted radical prostatectomy: a single-tertiary center study.

PURPOSE: We aimed to compare perioperative outcomes, post-operative complications, and opioid use between AirSeal® and non-AirSeal® robotic-assisted radical prostatectomy (RARP). METHODS: We retrospectively collected data on 326 patients who underwent elective RARP at our institution either with or without AirSeal®. The first 60 cases were excluded accounting for the institutions' learning curve of RARP. Patient demographics, oncologic, pathologic, and surgical characteristics between AirSeal® and non-AirSeal® cases were compared. Furthermore, outcomes of interest including operative time, length of stay, morbidity, and opioid use for pain management were compared between the two groups. Univariate linear and logistic regression models were developed. RESULTS: The AirSeal® group consisted of 125 (38.3%) patients while the non-AirSeal® group consisted of 201 (61.7%) patients. No statistically significant difference was seen in terms of patient demographics, oncologic characteristics, surgical characteristics, and pathologic characteristics between the two groups. In addition, univariate linear regression showed that RARP with AirSeal® displayed shorter operative times by 12.3 min and a shorter length of hospital stay by 0.5 days compared to the non-AirSeal® group (p < 0.001). Furthermore, the AirSeal® group witnessed lower odds of Clavien-Dindo (CVD) Class > 2 complications (OR = 0.102) and a lower need for opioid use (OR = 0.49) compared to the non-AirSeal® group (p < 0.022). CONCLUSION: RARP using AirSeal® is associated with shorter operative times, shorter length of hospital stays, lower odds of CVD > 2 complications, and lower odds of opioid use with respect to non-AirSeal® RARP. The efficacy and cost effectiveness of using the AirSeal® system during RARP should be further studied and evaluated by clinical trials.

Low-impact laparoscopy in colorectal resection-A multicentric randomised trial comparing low-pressure pneumoperitoneum plus microsurgery versus low-pressure pneumoperitoneum alone: The PAROS II trial.

INTRODUCTION: Low-pressure pneumoperitoneum (LLP) in laparoscopy colorectal surgery (CS) has resulted in reduced hospital stay and lower analgesic consumption. Microsurgery (MS) in CS is a technique that has a significant impact with respect to postoperative pain. The combination of MS plus LLP, known as low-impact laparoscopy (LIL), has never been applied in CS. Therefore, this trial will assess the efficacy of LLP plus MS versus LLP alone in terms of decreasing postoperative pain 24 h after surgery, without taking opioids. METHOD: PAROS II will be a prospective, multicentre, outcome assessor-blinded, randomised controlled phase III clinical trial that compares LLP plus MS versus LLP alone in patients undergoing laparoscopic surgery for colonic or upper rectal cancer or benign pathology. The primary outcome will be the number of patients with postoperative pain 24 h after the surgery, as defined by a visual analogue scale rating ≤3 and without taking opioids. Overall, PAROS II aims to recruit 148 patients for 50% of patients to reach the primary outcome in the LLP plus MS arm, with 80% power and an 5% alpha risk. CONCLUSION: The PAROS II trial will be the first phase III trial to investigate the impact of LIL, including LLP plus MS, in laparoscopic CS. The results may improve the postoperative recovery experience and decrease opioid consumption after laparoscopic CS.

Effects of extremely low-pressure pneumoperitoneum on postoperative recovery after single site robot-assisted cholecystectomy: a randomized controlled trial.

PURPOSE: A robotic platform has enabled extremely low-pressure pneumoperitoneum (ELPP, 4 mmHg) to reduce surgical insults to human physiology during a minimally invasive surgery. The objective of this study was to investigate the effect of ELPP in single-site robotic cholecystectomy (SSRC) on postoperative pain, shoulder pain, and physiological changes during surgery compared to a standard pressure pneumoperitoneum (SPP, 12-14 mmHg). METHODS: A total of 182 patients who underwent an elective cholecystectomy were randomized into an ELPP SSRC group (n = 91) and an SPP SSRC group (n = 91). Postoperative pain was assessed at 6, 12, 24, and 48 h after surgery. The number of patients complaining of shoulder pain was observed. Intraoperative changes of ventilatory parameters were also measured. RESULTS: Postoperative pain scores (p = 0.038, p < 0.001, p < 0.001, and p = 0.015 at 6, 12, 24, and 48 h after surgery, respectively) and the number of patients with shoulder pain (p <0.001) were significantly lower in the ELPP SSRC group than in the SPP SSRC group. Intraoperative changes in peak inspiratory pressure (p < 0.001), plateau pressure (p < 0.001), EtCO2 (p < 0.001), and lung compliance (p < 0.001) were also less in the ELPP SSRC group. CONCLUSION: The ELPP during robotic cholecystectomy could significantly relieve postoperative pain and shoulder pain. In addition, the ELPP can reduce changes in lung compliance during surgery and the demand for postoperative analgesics, thereby improving the quality of life of patients during early stages of postoperative rehabilitation.

Low-pressure versus standard-pressure pneumoperitoneum in laparoscopic cholecystectomy: a systematic review and meta-analysis of randomized controlled trials.

INTRODUCTION: It has been previously demonstrated that the rise of intra-abdominal pressures and prolonged exposure to such pressures can produce changes in the cardiovascular and pulmonary dynamic which, though potentially well tolerated in the majority of healthy patients with adequate cardiopulmonary reserve, may be less well tolerated when cardiopulmonary reserve is poor. Nevertheless, theoretically lowering intra-abdominal pressure could reduce the impact of pneumoperitoneum on the blood circulation of intra-abdominal organs as well as cardiopulmonary function. However, the evidence remains weak, and as such, the debate remains unresolved. The aim of this systematic review and meta-analysis was to demonstrate the current knowledge around the effect of pneumoperitoneum at different pressures levels during laparoscopic cholecystectomy. MATERIALS AND METHODS: This systematic review and meta-analysis were reported according to the recommendations of the 2020 updated Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) guidelines, and the Cochrane handbook for systematic reviews of interventions. RESULTS: This systematic review and meta-analysis included 44 randomized controlled trials that compared different pressures of pneumoperitoneum in the setting of elective laparoscopic cholecystectomy. Length of hospital, conversion rate, and complications rate were not significantly different, whereas statistically significant differences were observed in post-operative pain and analgesic consumption. According to the GRADE criteria, overall quality of evidence was high for intra-operative bile spillage (critical outcome), overall complications (critical outcome), shoulder pain (critical outcome), and overall post-operative pain (critical outcome). Overall quality of evidence was moderate for conversion to open surgery (critical outcome), post-operative pain at 1 day (critical outcome), post-operative pain at 3 days (important outcome), and bleeding (critical outcome). Overall quality of evidence was low for operative time (important outcome), length of hospital stay (important outcome), post-operative pain at 12 h (critical outcome), and was very low for post-operative pain at 1 h (critical outcome), post-operative pain at 4 h (critical outcome), post-operative pain at 8 h (critical outcome), and post-operative pain at 2 days (critical outcome). CONCLUSIONS: This review allowed us to draw conclusive results from the use of low-pressure pneumoperitoneum with an adequate quality of evidence.

The impact of low pressure pneumoperitoneum in robotic assisted radical prostatectomy: a prospective, randomized, double blinded trial.

BACKGROUND: Robotic surgery has revolutionized postoperative outcomes across surgical specialties. However, the use of pneumoperitoneum comes with known risks given the change in physiological parameters that accompany its utilization. A recent internal review found a 7% decrease in postoperative ileus rates when utilizing a pneumoperitoneum of 12 mmHg over the standard 15 mmHg in robotic assisted radical prostatectomies (RARP). OBJECTIVE: The purpose of this study is to prospectively evaluate the utility of lower pressure pneumoperitoneum by comparing 8 mmHg and 12 mmHg during RARP. DESIGN, SETTING AND PARTCIPANTS: Patients were randomly assigned to undergo robotic assisted radical prostatectomy at a pneumoperitoneum pressure of 12 mmHg or 8 mmHg. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was development of postoperative ileus and secondary outcomes were length of operation, estimated blood loss and positive surgical margin status. RESULTS AND LIMITATIONS: A total of 201 patients were analyzed; 96 patients at 8 mmHg and 105 patients at 12 mmHg. The groups were adequately matched as there were no differences between demographic parameters or medical comorbidities. There was a decrease in postoperative ileus rates with lower pneumoperitoneum pressures; 2% at 8 mmHg and 4.8% at 12 mmHg. There were no clinically significant differences in estimated blood loss, total length of operative time and positive margin status. CONCLUSIONS: Lower pressure pneumoperitoneum during robotic assisted radical prostatectomy is non-inferior to higher pressure pneumoperitoneum levels and the experienced surgeon may safely perform this operation at 8 mmHg to take advantage of the proposed benefits.

Low-pressure pneumoperitoneum with deep neuromuscular blockade in metabolic surgery to reduce postoperative pain: a randomized pilot trial.

BACKGROUND: For metabolic laparoscopic surgery, higher pressures up to 20 mmHg are often used to create a surgical field of sufficient quality. This randomized pilot study aimed to determine the feasibility, safety and tolerability of low intraabdominal pressure (IAP) and deep neuromuscular blockade (NMB) to reduce postoperative pain. METHODS: In a teaching hospital in the Netherlands, 62 patients eligible for a laparoscopic Roux-en-Y gastric bypass (LRYGB) were randomized into one of four groups in a 2 × 2 factorial design: deep/moderate NMB and standard (20 mmHg)/low IAP (12 mmHg). Patient and surgical team were blinded. Primary outcome measure was the surgical field quality, scored on the Leiden-Surgical Rating Scale (L-SRS). Secondary outcome measures were (serious) adverse events, duration of surgery and postoperative pain. RESULTS: 62 patients were included. L-SRS was good or perfect in all patients that were operated under standard IAP with deep or moderate NMB. In 40% of patients with low IAP and deep NMB, an increase in IAP was needed to improve surgical overview. In patients with low IAP and moderate NMB, IAP was increased to improve surgical overview in 40%, and in 75% of these cases a deep NMB was requested to further improve the surgical overview. Median duration of surgery was 38 min (IQR34-40 min) in the group with standard IAP and moderate NMB and 52 min (IQR46-55 min) in the group with low IAP and deep NMB. CONCLUSIONS: The combination of moderate NMB and low IAP can create insufficient surgical overview. Larger trials are needed to corroborate the findings of this study. TRIAL REGISTRATION: Dutch Trial Register: Trial NL7050, registered 28 May 2018. https://www.trialregister.nl/trial/7050 .

[Low-pressure pneumoperitoneum with abdominal elevation in laparoscopic radical prosta-tectomy in elderly patients with a localized form of prostate cancer.]

Prostate cancer is an actual problem among males of older age groups, while the concomi-tant premorbid background of this category of patients often leads to the development of postopera-tive complications using the standard surgical method. The article presents the results of using low-pressure pneumoperitoneum with anterior abdominal wall lifting for laparoscopic radical prostatec-tomy in elderly patients with a localized form of prostate cancer. Convincingly shown that the use of low-pressure techniques pneumoperitoneum with lifting anterior abdominal wall ensures satis-factory operating field, obtains stable indicators of operational monitoring and allow to reduce the duration of the operation, as well as reduce the duration of hospitalization and incidence of postoperative complications.

Deep neuromuscular blockade improves surgical conditions during low-pressure pneumoperitoneum laparoscopic donor nephrectomy.

BACKGROUND: Evidence indicates that low-pressure pneumoperitoneum (PNP) reduces postoperative pain and analgesic consumption. A lower insufflation pressure may hamper visibility and working space. The aim of the study is to investigate whether deep neuromuscular blockade (NMB) improves surgical conditions during low-pressure PNP. METHODS: This study was a blinded randomized controlled multicenter trial. 34 kidney donors scheduled for laparoscopic donor nephrectomy randomly received low-pressure PNP (6 mmHg) with either deep (PTC 1-5) or moderate NMB (TOF 0-1). In case of insufficient surgical conditions, the insufflation pressure was increased stepwise. Surgical conditions were rated by the Leiden-Surgical Rating Scale (L-SRS) ranging from 1 (extremely poor) to 5 (optimal). RESULTS: Mean surgical conditions were significantly better for patients allocated to a deep NMB (SRS 4.5 versus 4.0; p < 0.01). The final insufflation pressure was 7.7 mmHg in patients with deep NMB as compared to 9.1 mmHg with moderate NMB (p = 0.19). The cumulative opiate consumption during the first 48 h was significantly lower in patients receiving deep NMB, while postoperative pain scores were similar. In four patients allocated to a moderate NMB, a significant intraoperative complication occurred, and in two of these patients a conversion to an open procedure was required. CONCLUSIONS: Our data show that deep NMB facilitates the use of low-pressure PNP during laparoscopic donor nephrectomy by improving the quality of the surgical field. The relatively high incidence of intraoperative complications indicates that the use of low pressure with moderate NMB may compromise safety during LDN. Clinicaltrials.gov identifier: NCT 02602964.