ROBOTIC ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY VERSUS RETROPUBIC RADICAL PROSTATECTOMY: A PROSPECTIVE ASSESSMENT OF POSTOPERATIVE PAIN

0022-5347/05/1743-0912/0 THE JOURNAL OF UROLOGY® Copyright © 2005 by AMERICAN UROLOGICAL ASSOCIATION

Vol. 174, 912–914, September 2005 Printed in U.S.A.

DOI: 10.1097/01.ju.0000169455.25510.ff

ROBOTIC ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY VERSUS RETROPUBIC RADICAL PROSTATECTOMY: A PROSPECTIVE ASSESSMENT OF POSTOPERATIVE PAIN TODD M. WEBSTER, S. DUKE HERRELL,* SAM S. CHANG, MICHAEL S. COOKSON, ROXELYN G. BAUMGARTNER, LAURA W. ANDERSON AND JOSEPH A. SMITH, JR.† From the Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee

ABSTRACT

Purpose: Laparoscopic prostatectomy, whether or not coupled with robotic assistance, is often considered less invasive than open radical retropubic prostatectomy (RRP). Minimal postoperative pain has been reported following robot assisted laparoscopic prostatectomy (RALP) but there have been few comparative studies with RRP. We compared perioperative narcotic use and patient reported pain in a prospective patient series. Materials and Methods: Between June 2003 and May 2004, 314 patients underwent radical prostatectomy at our institution, including RALP in 159, RRP in 154 and conversion in 1. All patients were treated on a postoperative clinical pathway that included 30 mg ketorolac intravenously immediately postoperatively, followed by 15 mg intravenously every 6 hours. No regional anesthesia (epidural/spinal) narcotics or patient controlled analgesic pumps were used. All narcotic use was converted to morphine sulfate equivalents for purpose of analysis. A Likert scale of 0 to 10 was used to assess pain on the day of surgery, and on postoperative days 1 and 14. Results: The total mean morphine sulfate equivalent ⫾ SD in patients in the RALP and RRP groups was low and, when corrected for length of stay, it was not statistically different (22.41 ⫾ 1.13 vs 23.01 ⫾ 1.16 mg, p ⫽ 0.72). Mean Likert pain perception scores were low at all time points in the RALP and RRP groups but statistically lower on the day of surgery in the RALP cohort (2.05 ⫾ 1.99 vs 2.60 ⫾ 2.25, p ⫽ 0.027). Patient reported mean pain scores were almost identical for RALP vs RRP on postoperative days 1 (1.76 ⫾ 1.87 vs 1.73 ⫾ 1.77, p ⫽ 0.880) and 14 (2.51 ⫾ 1.91 vs 2.42 ⫾ 1.84, p ⫽ 0.722). Conclusions: Perioperative narcotic use and patient reported pain are low regardless of the surgical approach used for radical prostatectomy. RALP did not provide a clinically meaningful decrease in pain compared with RRP, primarily because of the low pain scores reported in each group. Outcomes other than pain will ultimately determine the role of laparoscopic radical prostatectomy and RALP. KEY WORDS: prostate, robotics, prostatectomy, laparoscopy, pain

For many operations 1 of the decided advantages of a laparoscopic approach is the less invasive aspect compared with an open surgical incision. Minimally invasive incisions for laparoscopy may create less postoperative pain and decrease the analgesic requirement. Minimizing the amount of perioperative narcotics can significantly impact several measures of postoperative morbidity, including pulmonary function and ileus duration. Postoperative treatment in patients undergoing radical retropubic prostatectomy (RRP) has changed substantially in the last decade.1 Earlier patient discharge from the hospital has been shown to be not only feasible, but also safe with no apparent increase in postoperative complications.2 Pain from the surgical incision or prolonged ileus, partially attributable to narcotic analgesic use, are the factors that most commonly limit early discharge home after RRP.2 Many patients and clinicians alike assume that laparo-

scopic prostatectomy is less morbid and associated with less postoperative pain than RRP. However, experienced surgeons recognize that patients often require relatively minimal analgesia for the lower midline abdominal incision used for contemporary RRP. Virtually all opinions regarding postoperative pain with radical prostatectomy are based on anecdotal experience or observations from retrospective series of patients undergoing a single surgical technique. We report a prospective comparison of patient reported pain and the analgesic requirement between patients undergoing robot assisted laparoscopic prostatectomy (RALP) and RRP. MATERIALS AND METHODS

All patients undergoing radical prostatectomy at our institution between June 2003 and May 2004 were included in this prospective study. Study design and informed consent documentation were approved by the Institutional Review Board at Vanderbilt University Medical Center and obtained from all patients. All patients had clinically localized carcinoma of the prostate and underwent RRP or RALP. The choice of surgical approach was according to patient preference after discussion of the risks, benefits and alternatives with the attending surgeon. No demographic, clinical or oncological criteria were used to select the surgical approach.

Submitted for publication August 16, 2004. Study received Institutional Review Board, Vanderbilt University Medical Center approval. * Financial interest and/or other relationship with Ethicon Endosurgery, Aesculap and Intuitive Surgical. † Correspondence: Department of Urologic Surgery, Vanderbilt University Medical Center, A 1302 Medical Center North, Nashville, Tennessee 37232-2765 (telephone: 615-343-0234; FAX: 615-3228990). 912

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Patients were treated on a common perioperative care pathway. General anesthesia was used in all patients. Those undergoing RRP underwent a midline incision that generally extended from several cm below the umbilicus to the pubis with a Bookwalter self-retaining retractor used for exposure. For RALP a 5 port technique was used. The 12 mm camera port was placed at the umbilicus and 3, 8 mm ports were placed for the robotic arms. A 12 mm port was placed in the right lower quadrant for the table side assistant surgeon. Pelvic lymphadenectomy was performed routinely in all cases. Nerve sparing was performed if indicated clinically, as guided by patient age, preoperative erectile function and oncological parameters. The specimen was extracted by enlarging the umbilical port. A single closed suction drain was placed in all patients in each group. No regional anesthetic injections or catheters were used intraoperatively or postoperatively. Ketorolac was prescribed at the same dose, route and frequency in all patients in this study until discharge home unless contraindicated with 30 mg administered intravenously immediately postoperatively and 15 mg administered intravenously every 6 hours for 24 hours. Patient controlled analgesia was not used. Intravenous morphine or oral oxycodone was administered as necessary at patient request. Narcotic use during hospitalization was converted to morphine sulfate equivalents (MSEs) and corrected for length of hospital stay. Patient reported pain was collected using a validated questionnaire and a 10-point Likert reporting system. Pain was assessed 6 hours, 24 hours and 2 weeks postoperatively by the patient, who completed the Likert pain severity score. At discharge home patients were given a prescription for oral oxycodone to use as needed for the next 2 weeks. Statistical comparisons were performed using SPSS for the Social Sciences, version 11.5 for Windows (SPSS, Chicago, Illinois). RESULTS

Between June 2003 and May 2004, 314 patients underwent radical prostatectomy at our institution, including RALP in 159, RRP in 154 and conversion in 1. They were similar with respect to age, race and clinical parameters (see table). Mean prostate specific antigen ⫾ SD was statistically higher in the RRP group (6.31 ⫾ 4.80 vs 8.62 ⫾ 8.64 ng/ml, p ⫽ 0.004) but the median was similar for RALP vs RRP (5.3 vs 5.7 ng/ml). Clinical stage and Gleason score were not statistically different. Total MSE use exclusive of ketorolac in patients in the RALP vs RRP groups was low and, when corrected for length of stay, it was not statistically different (22.41 ⫾ 1.13 vs 23.01 ⫾ 1.16 mg, p ⫽ 0.72, see table). In the RALP group 11 patients (7%) did not receive ketorolac compared with 10 (6%) in the RRP group. Mean Likert pain perception scores were low in the 2 groups but statistically lower on the day of surgery in the RALP cohort (2.05 ⫾ 1.99 vs 2.60 ⫾ 2.25, p ⫽ 0.27). On postoperative day (POD) 1 patient reported mean pain scores were almost identical in the RALP vs RRP groups (1.76 ⫾ 1.87 vs 1.73 ⫾ 1.77, p ⫽ 0.880). On POD 14 there was no statistically significant difference between RALP and RRP groups (2.51 ⫾ 1.91 vs 2.42 ⫾ 1.84, p ⫽ 0.722, see table). DISCUSSION

Laparoscopic surgery has assumed an important role in urology as well as in other surgical specialties, primarily because of its minimally invasive character compared with alternative surgical approaches. Pure and hand assisted laparoscopic nephrectomy have been shown to decrease postoperative pain and allow more rapid convalescence.3, 4 Furthermore, the decreased analgesic requirement with laparoscopic surgery can affect narcotic related morbidity, such as impaired pulmonary function, decreased mental status and intestinal ileus.

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Demographic and clinical data, MSE and patient reported pain Variable No. pts (% white) Age Prostate specific antigen (ng/ml) MSE (mg): Total Corrected for LOS POD pt reported pain (range 1–10): 0 1 14 * Statistically significant.

Mean RALP ⫾ SD

Mean RRP ⫾ SD

p Value

159 (91.5) 59.42 ⫾ 7.02 6.31 ⫾ 4.80

154 (89.3) 60.06 ⫾ 7.78 8.62 ⫾ 8.64

(0.573) 0.443 0.004*

21.07 ⫾ 14.87 22.41 ⫾ 1.13

24.39 ⫾ 14.31 23.01 ⫾ 1.16

0.041* 0.717

2.05 ⫾ 1.99 1.76 ⫾ 1.87 2.51 ⫾ 1.91

2.60 ⫾ 2.25 1.73 ⫾ 1.77 2.42 ⫾ 1.84

0.027* 0.880 0.722

Pain after RRP has been the subject of considerable attention in recent years. Various methods of analgesia are used. Good results have been reported with continuous epidural analgesia, intrathecal injections, patient controlled analgesia and nonsteroidal anti-inflammatory drugs.5⫺7 An explanation for the success of these various methods may be that the lower midline abdominal incision required for radical prostatectomy does not usually cause severe pain. For RALP the cumulative size of the incisions is approximately 5 to 6 cm after specimen removal, which is slightly less than the standard RRP incision. However, pain related to surgical incisions varies depending on several factors. Upper abdominal incisions are generally more painful than those in the lower abdomen because of the involvement of the upper abdomen with respiration. Incisions that follow anatomical demarcations such as the linea alba may be less painful than those that require incision through musculature. A lower midline abdominal incision allows separation without actual incision of the rectus muscles. Furthermore, radical prostatectomy can be accomplished through a minimal incision of 8 to 10 cm. Thus, unlike the situation with nephrectomy, in which a generous upper abdominal incision is required for an open surgical approach, there is less opportunity for significant improvement in postoperative pain with laparoscopic radical prostatectomy. Our results are at variance with reports showing decreased pain with RALP or pure laparoscopic prostatectomy.8⫺10 In fact, the most striking finding in our study was the excellent pain control achieved in the 2 groups. Neither RRP nor RALP was associated with a mean patient reported pain score exceeding 3 of 10 at any time point postoperatively. In general pain scores less than 4 are descriptively termed mild pain.11 Our patients reported minimal pain, although neither patient controlled analgesia nor regional blockage (epidural or intrathecal narcotic) was used. The total amount of narcotic analgesia in the 2 cohorts was extremely small and not statistically different when adjusted for length of stay. Ketorolac is an effective postoperative analgesic that avoids many side effects of narcotics.12 Its routine use in our patients was highly effective for controlling postoperative pain. This is a prospective but nonrandomized study. A further limitation is that we prospectively compared RRP, in which the primary surgeon had experience with performing more than 2,000 of these operations, with an RALP cohort incorporating our initial experience with this surgical approach. Early in our experience the longer duration of the robotic surgery and accompanying pneumoperitoneum could have increased postoperative pain in the RALP group. Furthermore, the quality of some vesicourethral anastomoses early in our series was less than desirable and may have allowed intraperitoneal urine leakage, which might have contributed to postoperative pain. Nonetheless, we observed no significant difference when comparing our earliest RALP experience with later results. Furthermore, even considering these

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factors it is highly unlikely that RALP would show a clinically meaningful improvement compared with RRP, given the low pain scores and narcotic use in the RRP group. Postoperative pain is only 1 outcome measure to consider after radical prostatectomy and few patients would consider it the most important one. Comparison of margin status, postoperative continence and erectile function ultimately determine the role of RALP. However, our data are important since laparoscopic prostatectomy is frequently promoted as a less invasive procedure than RRP and 1 associated with significantly less postoperative pain. Our data do not support that contention. CONCLUSIONS

The surgical approach (RRP or RALP) to radical prostatectomy does not appear to significantly influence patient perioperative pain or analgesic requirements. Each group had excellent pain control with minimal narcotic use. Outcome measures other than postoperative pain ultimately determine the role of RALP. REFERENCES

1. Holzbeierlein, J. M. and Smith, J. A.: Radical prostatectomy and collaborative care pathways. Semin Urol Oncol, 18: 60, 2000 2. Koch, M. O., Smith, J. A., Jr., Hodge, E. M. and Brandell, R. A.: Prospective development of a cost-efficient program for radical retropubic prostatectomy. Urology, 44: 311, 1994 3. Dunn, M. D., Portis, A. J., Shalhav, A. L., Elbahnasy, A. M., Heidorn, C., McDougall, E. M. et al: Laparoscopic versus open radical nephrectomy: a 9-year experience. J Urol, 164: 1153, 2000 4. Nelson, C. P. and Wolf, J. S., Jr.: Comparison of hand assisted versus standard laparoscopic radical nephrectomy for suspected renal cell carcinoma. J Urol, 167: 1989, 2002 5. Eandi, J. A., deVere White, R. W., Tunuguntla, H. S., Bohringer, C. H. and Evans C. P.: Can single dose preoperative intrathecal morphine sulfate provide cost-effective postoperative analgesia and patient satisfaction during radical prostatectomy in the current era of cost containment? Prostate Cancer Prostatic Dis, 5: 226, 2002 6. Frank, E., Sood, O. P., Torjman, M., Mulholland, S. G. and Gomella, L. G.: Postoperative epidural analgesia following radical retropubic prostatectomy: outcome assessment. J Surg Oncol, 67: 117, 1998 7. Stanley, B. K., Noble, M. J., Gilliland, C., Weigel, J. W., Mebust, W. K. and Austenfeld, M. S.: Comparison of patient-controlled analgesia versus intramuscular narcotics in resolution of postoperative ileus after radical retropubic prostatectomy. J Urol, 150: 1434, 1993 8. Menon, M., Tewari, A., Baize, B., Guillonneau, B. and Vallancien, G.: Prospective comparison of radical retropubic prostatectomy and robot-assisted anatomic prostatectomy: the

Vattikuti Urology Institute experience. Urology, 60: 864, 2002 9. Guillonneau, B. and Vallancien, G.: Laparoscopic radical prostatectomy: the Montsouris technique. J Urol, 163: 1643, 2000 10. Bhayani, S. B., Pavlovich, C. P., Hsu, T. S., Sullivan, W. and Su, L. M.: Prospective comparison of short-term convalescence: laparoscopic radical prostatectomy versus open radical retropubic prostatectomy. Urology, 61: 612, 2003 11. Serlin, R. C., Mendoza, T. R., Nakamura, Y., Edwards, K. R. and Cleeland, C. S.: When is cancer pain mild, moderate or severe? Grading pain severity by its interference with function. Pain, 61: 277, 1995 12. Gwirtz, K. H., Kim, H. C., Nagy, D. J., Young, J. V., Byers, R. S., Kovach, D. A. et al: Intravenous ketorolac and subarachnoid opioid analgesia in the management of acute postoperative pain. Reg Anesth, 20: 395, 1995 EDITORIAL COMMENT An experienced surgeon with open and robotic RRP, and a pioneer in clinical care paths routinely provides intravenous ketorolac for postoperative pain to minimize the adverse side effects of supplemental opioids. Consequently patients typically have an uneventful postoperative course and know what to expect. This minimizes length of stay and leaves little room for improvement. The prospective but not randomized comparison of postoperative pain and hospital narcotic use adjusted for length of stay in patients treated with open and robotic RRP reported reveals no material difference between open and robotic RRP. However, 1 group could have required more oral oxycodone after discharge home. Although the result differs from that usually reported from such comparisons, the authors provide a valid explanation of why open RRP, with a small lower midline abdominal incision that does not transect muscle, is not a particularly painful operation. William J. Catalona Department of Urology Northwestern Feinberg School of Medicine Clinical Prostate Cancer Program Robert H. Lurie Comprehensive Cancer Center Northwestern Memorial Hospital Chicago, Illinois REPLY BY AUTHORS Our failure to show a statistically significant difference in postoperative pain between the 2 treatment groups was because of the low pain scores after both operations. Based on an experience with more than 2,000 radical retropubic prostatectomies by the senior author of our study, we did not expect to find much difference in postoperative pain when we started performing robotic assisted laparoscopic prostatectomy over 2 years ago. Significant advantages of the robotic assisted laparoscopic approach may emerge but with appropriate postoperative analgesic management and use of a relatively small incision, pain is not a prominent feature of recovery from radical prostatectomy regardless of the surgical approach.