Matias V Madsen1, Olav Istre, Anne K Staehr-Rye, Henrik H Springborg, Jacob Rosenberg, Jørgen Lund, Mona R Gätke. 1. From the Department of Anaesthesiology, Herlev Hospital, University of Copenhagen, Herlev, Denmark (MVM, AKS-R, MRG), Department of Anaesthesiology and Center for Minimal Invasive Gynaecology, Aleris-Hamlet Hospitals Copenhagen, Søborg, Denmark (OI, HHS, JL), and Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark (JR).
Abstract
BACKGROUND:Postoperative shoulder pain remains a significant problem after laparoscopy. Pneumoperitoneum with insufflation of carbon dioxide (CO2) is thought to be the most important cause. Reduction of pneumoperitoneum pressure may, however, compromise surgical visualisation. Recent studies indicate that the use of deep neuromuscular blockade (NMB) improves surgical conditions during a low-pressure pneumoperitoneum (8 mmHg). OBJECTIVE: The aim of this study was to investigate whether low-pressure pneumoperitoneum (8 mmHg) and deep NMB (posttetanic count 0 to 1) compared with standard-pressure pneumoperitoneum (12 mmHg) and moderate NMB (single bolus of rocuronium 0.3 mg kg with spontaneous recovery) would reduce the incidence of shoulder pain and improve recovery after laparoscopic hysterectomy. DESIGN: A randomised, controlled, double-blinded study. SETTING:Private hospital in Denmark. PARTICIPANTS: Ninety-nine patients. INTERVENTIONS: Randomisation to either deep NMB and 8 mmHg pneumoperitoneum (Group 8-Deep) or moderate NMB and 12 mmHg pneumoperitoneum (Group 12-Mod). Pain was assessed on a visual analogue scale (VAS) for 14 postoperative days. MAIN OUTCOME MEASURES: The primary endpoint was the incidence of shoulder pain during 14 postoperative days. Secondary endpoints included area under curve VAS scores for shoulder, abdominal, incisional and overall pain during 4 and 14 postoperative days; opioid consumption; incidence of nausea and vomiting; antiemetic consumption; time to recovery of activities of daily living; length of hospital stay; and duration of surgery. RESULTS:Shoulder pain occurred in 14 of 49 patients (28.6%) in Group 8-Deep compared with 30 of 50 (60%) patients in Group 12-Mod. Absolute risk reduction was 0.31 (95% confidence interval 0.12 to 0.48; P = 0.002). There were no differences in any secondary endpoints including area under the curve for VAS scores. CONCLUSION:Deep NMB and low-pressure pneumoperitoneum (8 mmHg) reduced the incidence of shoulder pain after laparoscopic hysterectomy in comparison to moderate NMB and standard-pressure pneumoperitoneum (12 mmHg). TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01722097.
RCT Entities:
BACKGROUND: Postoperative shoulder pain remains a significant problem after laparoscopy. Pneumoperitoneum with insufflation of carbon dioxide (CO2) is thought to be the most important cause. Reduction of pneumoperitoneum pressure may, however, compromise surgical visualisation. Recent studies indicate that the use of deep neuromuscular blockade (NMB) improves surgical conditions during a low-pressure pneumoperitoneum (8 mmHg). OBJECTIVE: The aim of this study was to investigate whether low-pressure pneumoperitoneum (8 mmHg) and deep NMB (posttetanic count 0 to 1) compared with standard-pressure pneumoperitoneum (12 mmHg) and moderate NMB (single bolus of rocuronium 0.3 mg kg with spontaneous recovery) would reduce the incidence of shoulder pain and improve recovery after laparoscopic hysterectomy. DESIGN: A randomised, controlled, double-blinded study. SETTING: Private hospital in Denmark. PARTICIPANTS: Ninety-nine patients. INTERVENTIONS: Randomisation to either deep NMB and 8 mmHg pneumoperitoneum (Group 8-Deep) or moderate NMB and 12 mmHg pneumoperitoneum (Group 12-Mod). Pain was assessed on a visual analogue scale (VAS) for 14 postoperative days. MAIN OUTCOME MEASURES: The primary endpoint was the incidence of shoulder pain during 14 postoperative days. Secondary endpoints included area under curve VAS scores for shoulder, abdominal, incisional and overall pain during 4 and 14 postoperative days; opioid consumption; incidence of nausea and vomiting; antiemetic consumption; time to recovery of activities of daily living; length of hospital stay; and duration of surgery. RESULTS: Shoulder pain occurred in 14 of 49 patients (28.6%) in Group 8-Deep compared with 30 of 50 (60%) patients in Group 12-Mod. Absolute risk reduction was 0.31 (95% confidence interval 0.12 to 0.48; P = 0.002). There were no differences in any secondary endpoints including area under the curve for VAS scores. CONCLUSION: Deep NMB and low-pressure pneumoperitoneum (8 mmHg) reduced the incidence of shoulder pain after laparoscopic hysterectomy in comparison to moderate NMB and standard-pressure pneumoperitoneum (12 mmHg). TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01722097.
Authors: D M D Özdemir-van Brunschot; A E Braat; M F P van der Jagt; G J Scheffer; C H Martini; J F Langenhuijsen; R E Dam; V A Huurman; D Lam; F C d'Ancona; A Dahan; M C Warlé Journal: Surg Endosc Date: 2017-06-22 Impact factor: 4.584
Authors: Edoardo De Robertis; Anna Caprino Miceli; Giorgio L Colombo; Antonio Corcione; Yigal Leykin; Luigia Scudeller; Enrico Vizza; Paolo Scollo Journal: JMIR Res Protoc Date: 2018-07-09