Philadelphia -- A pain-relief system that provides continuous infusion of local anesthetic directly to the surgical site appears effective for reducing pain after breast augmentation surgery, but it is questionable whether patients are willing to pay extra to use the pump and achieve that benefit, said Richard L. Dolsky, M.D., at the American Academy of Cosmetic Surgery Symposium on Body Augmentation and Contouring.
The pain relief system (On-Q, I-Flow) consists of a balloon pump/anesthetic reservoir worn in a fanny pack. Tubing connects the reservoir to miniature "soaker" catheters that are inserted intraoperatively through the lateral breast into the submuscular pocket prior to placing the implant. The reservoir is filled with lidocaine 1 percent, which is delivered at a rate of 2 cc/hour for 72 hours. The catheters are then easily removed from the surgical site. When the pump is used, patients also receive 10 cc of a long-acting local anesthetic (0.5 percent Marcaine with epinephrine) instilled directly into the pocket prior to implant placement.
To evaluate the efficacy of the pump in controlling pain in breast augmentation patients, Dr. Dolsky, chairman, department of plastic and reconstructive surgery, Mercy Surgery Center, Havertown, Pa., performed a comparative study with three parallel arms. In one group, 10 women received the intraoperative long-acting local anesthetic with the pump, a control group of five women received intraoperative long-acting local anesthetic alone, and a third group of seven women received no adjunctive local treatment for pain. All procedures were performed with the same technique, which involved periareolar incisions with subpectoral implant placement.
Efficacy was judged by asking patients to rate the severity of their pain at one hour after surgery and again at 48 hours postoperative. For more objective determination of pain, the number of narcotic analgesic pills (Percocet) taken while the patient was in the post-anesthesia care unit (PACU) and during the first 48 hours after surgery were counted.
Results may not justify extra cost
The results of all of those measures except for the last favored the pain pump when compared with both control groups, while there was also a benefit for using intraoperative long-acting local anesthetic alone versus no anesthetic in the same three endpoints. However, of patients who have been told about the availability of the pump, only a single woman has been willing to pay the extra $225 to cover its cost, Dr. Dolsky said.
"There is no doubt that breast augmentation is the most painful cosmetic procedure a patient can undergo, especially with subpectoral implant placement," he said. "That background motivated me to evaluate a potential role for this device, but also made it particularly interesting to find that patients have been so averse to paying an additional charge, which is relatively small when compared with the total cost of the procedure."
"I have no doubt more woman might use the pump if there was no extra fee, and that leads to the questions of whether it is worthwhile to raise the fee for the surgery itself to cover the cost of the pump and attain the benefit of decreased pain, or should one just put the long-acting local anesthetic into the wound intraoperatively and achieve almost the same pain reduction at a much lower cost."
In the study, the subjective pain ratings were made using a scale of 0 (no pain) to 5 (worst pain imaginable). Mean scores at one hour after surgery for the pump, long-acting local anesthetic, and no-anesthetic controls were 1.8, 2.6, and 3.1, respectively, and the mean number of pain pills consumed in the PACU per patient for those corresponding groups was 0.2, 0.4, and 0.9, respectively.
At 48 hours after surgery, patients who had the pump rated their pain at an average level of 1.9. The mean pain ratings for the long acting local anesthetic and no anesthetic controls were 2.5 and 3.3, respectively. Counter-intuitively, however, the mean number of pain pills consumed during the first 48 hours after surgery was least in the no-anesthetic control group, intermediate in the pump group, and highest for women who received the long-acting local anesthetic alone, 7 versus 8 versus 10, respectively.
"One explanation for those unexpected results might be that women who received the intraoperative anesthetic developed more severe pain when its effect wore off after 10 to 12 hours and then tried to catch up, while the women in the control group had a more constant level of pain throughout the postop period," Dr. Dolsky said.
The pump catheters were easy to place and not associated with any complications. Once familiarized with the system, Dr. Dolsky said its use probably added no more than five minutes to the procedure.
There were no adverse reactions associated with the catheters or local anesthetic, although in a single patient, a catheter became dislodged unilaterally during transfer from the operating table. That woman was not asked to differentiate the severity of pain on her right and left sides.
Dr. Dolsky has no financial interest in I-Flow. That company provided him with two pumps at no charge, but he paid for the rest of the pumps used in the study.