Jeremy D Kauffman1, Anh Thy H Nguyen2, Cristen N Litz3, Sandra M Farach4, JoAnn C DeRosa5, Raquel Gonzalez6, Ernest K Amankwah7, Paul D Danielson8, Nicole M Chandler9. 1. Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: jkauff10@jhu.edu. 2. Department of Health Informatics, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: anguye57@jhmi.edu. 3. Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: clitz@health.usf.edu. 4. Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: sandrafarach@gmail.com. 5. Clinical and Translational Research Organization, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: joann.derosa@jhmi.edu. 6. Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: rgonza35@jhmi.edu. 7. Department of Health Informatics, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: ernest.amankwah@jhmi.edu. 8. Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: paul.danielson@jhmi.edu. 9. Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: nicole.chandler@jhmi.edu.
Abstract
PURPOSE: The purpose of our study was to compare the effectiveness of transincisional (TI) versus laparoscopic-guided (LG) rectus sheath block (RSB) for pain control following pediatric single-incision laparoscopic cholecystectomy (SILC). METHODS:Forty-eight patients 10-21 years old presenting to a single institution for SILC from 2015 to 2018 were randomized toTI or LG RSB. Apart from RSB technique, perioperative care protocols were identical between groups. Pain scores were assessed with validated measures upon arrival in the postanesthesia care unit (PACU) and at regular intervals until discharge. The patients and those assessing them were blinded to RSB technique. The primary outcome was pain score 60 min after PACU arrival. Secondary outcomes included pain scores throughout the PACU stay, opioids (reported as morphine milligram equivalents (MME) per kg bodyweight) administered in PACU, length of stay, outpatient pain scores and opioid use, and adverse events. Groups were compared on outcomes using t test and generalized estimating equations for continuous variables and Fisher's exact test for categorical variables with significance at α = 0.05. RESULTS:Mean age of the 48 subjects was 15 years (range = 11-20). The majority (79%) were female. Indications for surgery included symptomatic cholelithiasis (n = 41), acute cholecystitis (n = 4), gallstone pancreatitis (n = 2) and choledocholithiasis (n = 1). Mean (standard deviation) operative time was 61 (±23) min overall. No statistically significant differences in demographics, indication, operative time, or intraoperative analgesia were observed between TI (n = 24) and LG (n = 24) groups. The mean 60-min pain score was 3.4 (±2.6) in the LG group versus 3.8 (±2.1) in the TI group (p = 0.573). No significant differences were detected between groups in overall PACU or outpatient pain scores, PACU or outpatient opioid use, length of stay, or incidence of complications. Overall, mean opioid use was 0.1 MME/kg in the PACU and 0.5 MME/kg in the outpatient setting. Mean postoperative length of stay was 0.2 day. There were no major complications. CONCLUSION:Laparoscopic-guided rectus sheath block is not superior to transincisional rectus sheath block for pain control following pediatric single-incision laparoscopic cholecystectomy. The single-incision laparoscopic approach combined with rectus sheath block resulted in effective pain control, low opioid use, and expedited length of stay with no major complications. LEVEL OF EVIDENCE: Level I, treatment study, randomized controlled trial.
RCT Entities:
PURPOSE: The purpose of our study was to compare the effectiveness of transincisional (TI) versus laparoscopic-guided (LG) rectus sheath block (RSB) for pain control following pediatric single-incision laparoscopic cholecystectomy (SILC). METHODS: Forty-eight patients 10-21 years old presenting to a single institution for SILC from 2015 to 2018 were randomized to TI or LG RSB. Apart from RSB technique, perioperative care protocols were identical between groups. Pain scores were assessed with validated measures upon arrival in the postanesthesia care unit (PACU) and at regular intervals until discharge. The patients and those assessing them were blinded to RSB technique. The primary outcome was pain score 60 min after PACU arrival. Secondary outcomes included pain scores throughout the PACU stay, opioids (reported as morphine milligram equivalents (MME) per kg bodyweight) administered in PACU, length of stay, outpatientpain scores and opioid use, and adverse events. Groups were compared on outcomes using t test and generalized estimating equations for continuous variables and Fisher's exact test for categorical variables with significance at α = 0.05. RESULTS: Mean age of the 48 subjects was 15 years (range = 11-20). The majority (79%) were female. Indications for surgery included symptomatic cholelithiasis (n = 41), acute cholecystitis (n = 4), gallstone pancreatitis (n = 2) and choledocholithiasis (n = 1). Mean (standard deviation) operative time was 61 (±23) min overall. No statistically significant differences in demographics, indication, operative time, or intraoperative analgesia were observed between TI (n = 24) and LG (n = 24) groups. The mean 60-min pain score was 3.4 (±2.6) in the LG group versus 3.8 (±2.1) in the TI group (p = 0.573). No significant differences were detected between groups in overall PACU or outpatientpain scores, PACU or outpatient opioid use, length of stay, or incidence of complications. Overall, mean opioid use was 0.1 MME/kg in the PACU and 0.5 MME/kg in the outpatient setting. Mean postoperative length of stay was 0.2 day. There were no major complications. CONCLUSION: Laparoscopic-guided rectus sheath block is not superior to transincisional rectus sheath block for pain control following pediatric single-incision laparoscopic cholecystectomy. The single-incision laparoscopic approach combined with rectus sheath block resulted in effective pain control, low opioid use, and expedited length of stay with no major complications. LEVEL OF EVIDENCE: Level I, treatment study, randomized controlled trial.