Controlling Pain After Total Hip and Knee Arthroplasty Using a Multimodal Protocol With Local Periarticular Injections

The Journal of Arthroplasty Vol. 22 No. 6 Suppl. 2 2007 Controlling Pain After Total Hip and Knee Arthroplasty Using a Multimodal Protocol With Local Periarticular Injections A Prospective Randomized Study Hari K. Parvataneni, MD,* Vineet P. Shah, DO, MPH,y Holly Howard, BA,y Naida Cole, BA,y Amar S. Ranawat, MD,y and Chitranjan S. Ranawat, MDy Abstract: In this prospective randomized study, patients undergoing total hip () or knee arthroplasty () were randomized to either a study group receiving periarticular injections or a control group receiving patient-controlled analgesia with or without femoral nerve block ( patients). All patients received a comprehensive multimodal perioperative protocol. Pain, recovery of functional milestones, and overall satisfaction were assessed. The study group demonstrated significantly lower average pain scores and higher overall satisfaction than the control group. There was no significant difference in pain scores between the study and control groups in the cohort. Both study groups demonstrated lower narcotic usage and side effects as well as improved early functional recovery. Periarticular injection with a multimodal protocol was shown to safely provide excellent pain control and functional recovery and can be substituted for conventional pain control modalities. Key words: total knee arthroplasty, total hip arthroplasty, periarticular injection, pain, functional recovery. 2007 Published by Elsevier Inc. From the *Massachusetts General Hospital, Boston, Massachusetts; and yranawat Orthopaedic Center, Lenox Hill Hospital, New York, New York. Submitted January 24, 2007; accepted March 27, 2007. No benefits or funds were received in support of this study. Reprint requests: Amar S. Ranawat, MD, Ranawat Orthopaedic Center, Lenox Hill Hospital, 100 East 77th St, New York, NY 10021. 2007 Published by Elsevier Inc. 0883-5403/07/1906-0004$32.00/0 doi:10.1016/j.arth.2007.03.034 Orthopedic procedures have been reported to be among the most painful of surgical procedures [1,2]. One of the most significant patient concerns regarding total joint arthroplasty is the anticipated pain directly related to surgical trauma during the postoperative recovery period. It has been reported that more than half of postoperative patients receive suboptimal pain control [3,4] and half of all patients undergoing total hip () or knee arthroplasty () will experience severe pain [5] in the early postoperative period. after and is tied directly to pain and comfort levels. Earlier mobilization, ambulation, and earlier return of normal gait are associated with more optimal pain control [6,7]. In addition, arthrofibrosis and diminished postoperative range of motion are closely related to postoperative pain and related joint splinting and immobilization [8]. Patient perceptions of surgical success are closely matched to residual pain, functional limitations, and speed of recovery [9,10]. The concept of multimodal pain control including local periarticular injection has received increasing interest in the recent literature [11-13], and published results are promising in terms of improved perioperative pain control, reduced need for narcotic medications, and reduced associated side effects [11,12]. Recent reports have used periarticular injections as a supplement to conventional pain control modalities including patient-controlled anesthesia (PCA) pumps and femoral nerve blocks 33

34 The Journal of Arthroplasty Vol. 22 No. 6 Suppl. 2 September 2007 Table 1. Components of a Multimodal Approach for and Preoperative patient education/clarification of expectations Preemptive analgesia Anesthesia technique Surgical Technique Intraoperative agents (including use of a novel periarticular injection) Postoperative analgesia (FNBs). In addition, most of the data reported have been on predischarge pain control and functional recovery. The study reported here evaluates a multimodal pain protocol using local periarticular injection as a substitute for conventional perioperative pain control modalities. We also report on postdischarge pain control, patient satisfaction, and functional recovery. Materials and Methods A detailed description of this multimodal perioperative pain control protocol has been published previously [14]. The key aspects of the described multimodal approach to pain control after or are outlined in Table 1. In summary, a comprehensive protocol is used for all patients. Preoperative patient education specific to recovery goals and timelines is emphasized and this is intended to reduce patient anxiety and misconceptions in the postoperative period that can negatively affect the patients' perception of pain. The specific pharmacologic agents used are selected to deemphasize use of high-dose, short-acting narcotics. The side effects and inconsistent effectiveness of narcotics is well established and narcotics are reserved for breakthrough or persistent pain. The specific use of analgesics and anti-inflammatories acting via different pathways is emphasized for a multimodal approach. Preemptive analgesia is a key component of this protocol and is initiated preoperatively on admission and continued through the postoperative period. Early conversion from parenteral to oral agents as well as the maintenance of an adequate baseline level of pain control with long-acting agents is important. The specific agents administered preoperatively are outlined in Table 2. All patients enrolled had a diagnosis of noninflammatory osteoarthritis. Patient factors such as body mass index (BMI) and comorbidities were not considered during the enrollment process. Patients were not excluded from the study because of significant comorbidity or included because of good general health or low BMI. The authors feel that the patients enrolled represent the population of a typical arthroplasty service. All patients received spinal anesthesia performed by 1 of 4 trained and experienced anesthesiologists working as part of the arthroplasty team. All patients must achieve complete anesthesia before incision. Supplementation with general anesthesia or systemic analgesia is considered a failure of regional technique. In addition, for patients receiving femoral blocks, the femoral blocks were performed by these same anesthesiologists and were verified to be successful with a complete block before the start of the procedure. Patients with incomplete blocks were eliminated from the study. The technique of reduced tissue trauma surgery is used in all patients. Inappropriate stretching, tearing, and maceration of the soft tissues including the skin is minimized by sharp dissection, adequate exposure, and appropriate tissue releases. Incision lengths varies between 10 and 20 cm depending on patient factors such as amount fat, resistance of the soft tissues, level of deformity, prior operations, and amount of contracture. For, a standard posterolateral approach to the hip was performed in all cases involving release of posterior structures from the piriformis tendon proximally to the gluteus maximus tendon distally. All released structures including the capsule are repaired at the end of the procedure. For, application of a pneumatic tourniquet is minimized. Direct mechanical trauma to the quadriceps and hamstring muscle compartments as well as ischemic injury to the entire distal extremity is therefore minimized. In addition, the pressure applied during use is maintained at approximately 100 mm Hg above the systolic blood pressure. The tourniquet is used for a brief period only for the cementation of the final implants. A standard extensile medial parapatellar approach was used in all patients. A deep drain is used routinely in all cases for 24 hours to minimize hematoma formation. Table 2. Perioperative Pain Management Protocol for and Preemptive analgesia/medications (admission area) 1. Celecoxib 200/400 mg orally 2. Oxycodone SR 10/20 mg orally 3. Pantoprazole 40 mg orally 4. Warfarin 5 mg orally Intraoperative injection 1. 0.5% Bupivacaine 200-400 mg 2. Morphine sulfate (0.4-1.0 ml) 4-10 mg 3. Epinephrine 1/1000 (0.3 ml) 300 μg 4. Methylprednisolone acetate 40 mg 5. Cefuroxime (10 ml) 750 mg 6. Normal saline 22 ml No steroids in diabetic/immunocompromised patients Vancomycin if allergic to penicillin Clonidine transdermal patch applied in operating room: 100 μg/24 h Postoperative analgesia/medications Recovery room 1. Ketorolac intravenously every 6 h (15 mg if >65 y, 30 mg if <65 y, hold if renal impairment) 2. If ketorolac is ineffective, morphine 2 to 4 mg intravenously every 15 min Orthopedic floor 1. Ketorolac intramuscularly every 6 h as needed (15 mg if >65 y, 30 mg if <65 y, hold if renal Impairment) 2. If ketorolac is ineffective, morphine 2 to 4 mg intramuscularly every 2 to 4 h 3. Celecoxib 200 mg orally daily for 10 d 4. Oxycodone SR 10/20 mg orally every 12 h for 48 h 5. Oxycodone 5 mg orally every 6 h as needed 6. Acetaminophen 1000 mg orally every 6 h 7. Pantoprazole 40 mg orally daily

Controlling Pain After and Parvataneni et al 35 Table 3. Injection Sites for Intraoperative Periarticular Injection Before final reduction Anterior capsule Iliopsoas tendon and insertion site After final reduction (before irrigation and closure) Abductors Fascia lata Gluteus maximus and its insertion Posterior capsule and short external rotators Synovium Before insertion of liner and reduction Posterior capsule Posteromedial and posterolateral structures After reduction Extensor mechanism Synovium Capsule Pes anserinus, anteromedial capsule, and periosteum Iliotibial band Collateral ligaments and origins The components of the intraoperative periarticular injection are detailed in Table 2 and the sites of injection are outlined in Table 3. This is considered to be the most important and effective component of this pain protocol. Direct analgesic effect is produced by a long-acting local anesthetic as well as local opioid via different mechanisms. In addition, epinephrine prolongs the action of the local agents by decreasing absorption by vasoconstriction via its α-adrenergic effects. In addition, it may have an effect in decreasing postoperative bleeding and hematoma. Morphine exerts its analgesic effects centrally, regionally, and locally by its effect on opioid receptors. Local administration allows sustained effect with a minimum of the typical opioid side effects (eg, sedation, nausea, and respiratory depression) which occur through central opioid receptors. Local administration of morphine has demonstrated advantages in reduction of postoperative pain in joint arthroplasty [15]. Clonidine exerts its effect via its α 2 -adrenergic actions. It results in potentiation of the actions of local anesthetic agents and local opioids via synergistic effects [16,17]. Transdermal administration allows sustained action for several days while minimizing potential side effects including bradycardia and hypotension. Corticosteroid is a key component of this injection. Numerous studies have demonstrated potent local antiinflammatory effects as well as reductions in the local stress responses to surgical trauma. By potently suppressing these physiologic responses to surgery, pain is improved and functional recovery should be improved. Local injection of corticosteroids has been used extensively in musculoskeletal tissues and joints without impairment of wound healing or other complications [18-20]. Institutional review board approval was obtained for this prospective, randomized clinical trial. All patients received the comprehensive perioperative pain protocol described and all patients underwent primary or for osteoarthritis. Surgery was performed by 1 of 2 senior surgeons. For the group, patients were randomized to receive a PCA (control group) or a local periarticular injection (study group). For the group, patients were randomized to either the control group (FNB at the end of the procedure and a PCA for 24 hours after surgery) or the study group (local periarticular injection only). As mentioned previously, all other aspects of the rehabilitation process and perioperative pain protocol were identical between groups. The only difference was the substitution of the local periarticular injection for the FNB + PCA ( group) or PCA ( group). A power analysis was performed to determine the number of subjects required. To demonstrate a 20% difference in each parameter with a P value of less than.05, it was determined that 30 patients were needed for each group for a total number of 120. Seventy-one patients were enrolled in the groups and 60 in the groups. The independent (unpaired) t test was used for determining statistical significance. Data was collected on each postoperative day of hospitalization and at 6 weeks and 3 months after surgery. All data were collected by research personnel who were blinded to the randomization. Pain control was evaluated by using the visual analog scale (0-10, with 0 being pain free and 10 being the worst pain), patient satisfaction scores (0-10, with 10 being the most satisfied), as well as patient expectations. Narcotic usage was documented using total dosage used. Side effects of narcotics including but not limited to nausea, vomiting, confusion, itching, rash, constipation, ileus, and urinary retention were documented. Functional recovery was evaluated using range of motion ( group), straight leg raising, onset of assisted ambulation, independent ambulation, use of walking aides, stair climbing, and recovery of milestones. Demographic Data Results Between October 2005 and March 2006, 71 patients were enrolled in the group and 60 patients in the group. For the group, 36 patients were randomized to the control group and 35 patients to the study group. For the group, 29 patients were randomized to the control group and 31 patients to the study group. There were no statistically significant differences between comparison groups demographically and in relation to the length of surgical incision. These data are summarized in Table 4. Pain control, satisfaction, and functional recovery data are summarized in Tables 5 and 6. Complications There were no manipulations performed. There were no cases of delayed wound healing, prolonged wound

36 The Journal of Arthroplasty Vol. 22 No. 6 Suppl. 2 September 2007 Table 4. Demographic Data and Incision Length Table 6. Functional Recovery PCA Group PCA Group No. of patients 35 36 Mean age (y) 64.0 61.3 Sex 14 female, 21 male 14 female, 22 male Mean BMI (kg/m 2 ) 26.9 28.1 Mean incision length (cm) 14.6 15.1 FNB + PCA Group No. of patients 31 29 Mean age (y) 68.5 70.5 Sex 14 female, 17 male 15 female, 14 male Mean BMI (kg/m 2 ) 29.0 29.4 Mean incision length (cm) 18.6 19.4 drainage, or wound infections. There were no cases requiring repeat surgery during the study period. Pain Control Patients in the hip study group had significantly lower pain scores on each day of hospitalization compared with those in the control group. On postoperative day 1, the mean pain score for the study group was 3.8 compared with 5.6 for the control group (P =.0067). Similarly, on postoperative days 2 and 3, the study group had mean pain scores of 2.8 and 2.6, respectively, vs 4.1 and 4.5, respectively, for the control group. Patient satisfaction was significantly higher for the study group during hospitalization (9.2 vs 6.7 for the control group). Overall narcotic usage was lower for the study group during hospitalization. Pain and satisfaction scores were comparable between groups at 6 weeks and 3 months after surgery. Table 5. Pain Control and Satisfaction PCA Group Mean pain score POD 1 3.8 5.6 POD 2* 2.8 4.1 POD 3* 2.6 4.5 POD 14 2.5 2.7 Mean satisfaction level, POD 1* 9.2 6.7 Mean pain score, POD 1 Mean satisfaction level, POD 1 POD indicates postoperative day. *P <.05 (statistically significant). FNB + PCA Group 4.3 5.3 9.0 7.8 SLR (POD 1)* 52% 15% Mean hospital stay (d)* 3.2 4.2 Disposition postdischarge 30% 50% 70% Home 50% Home FNB + PCA Group SLR (POD 1)* 63% 21% Mean hospital stay (d) 3.2 3.2 Disposition postdischarge 45% 80% 55% Home 20% Home Mean range of motion 66 62 (POD 2) Mean range of motion (3 mo) 118 114 SLR indicates straight leg raise. *P <.05 (statistically significant). Patients in the knee study group had lower pain scores on postoperative day 1 than the control group (4.3 vs 5.3) but this was not statistically significant. On subsequent days, pain scores were comparable. Patient satisfaction scores during hospitalization were 9.0 for the knee study group and 7.8 for the knee control group. For the knee study group, 56.5% of patients reported their pain to be less than expected compared with 37.5% for the control group. The knee control group consumed the highest amount of narcotics in this series. Six of the 29 patients in this group were confused during a portion of their hospitalization (vs 1 for the knee study group). Four of 29 patients in the knee control group had episodes of emesis on postoperative day 1 and 8 had episodes during their hospitalization (vs 2 and 3, respectively, in the knee study group). Pain and satisfaction scores were comparable between groups at 6 weeks and 3 months after surgery. Functional Recovery For the hip study group, 52% of patients were able to straight leg raise by postoperative day 1 vs 15% in the control group. The mean length of hospitalization was shorter for the study group (3.2 and 4.2 days, respectively). In addition, 70% of patients from the study group went home instead of to a rehabilitation vs 50% from the control group. For the knee study group, 63% of patients were able to straight leg raise by postoperative day 1 vs 21% in the control group. The mean length of hospitalization was 3.2 days for both groups, but 55% of patients from the study group went home instead of to a rehabilitation vs 20% from the control group. Mean knee range of motion was similar between groups on postoperative day 2 (66 for the study group vs 62 for

Controlling Pain After and Parvataneni et al 37 the control group) and at 3 months after surgery (117.7 and 114.0, respectively). Ambulation distances, use of assistive devices, stair climbing ability, limp, and functional ability were similar between groups at 6 weeks and 3 months after surgery for both the and series. Discussion There has been a significant push in the marketing and promotion of minimally invasive surgery (MIS) for total joint arthroplasties. Recent literature has been unable to demonstrate objective advantages in terms of improved pain and functional recovery from MIS as has been marketed [21-23]. In fact, complications including wound healing problems, component malposition, and femoral fracture may be increased [24,25]. The marketing claims made by MIS- and MIS- proponents have given misguided perceptions to the public regarding the current standard of care. It appears that pain control plays a much larger role in functional recovery than incision length. Key components of the protocol described include the use of a variety of pharmacologic agents exerting effects via differing mechanisms resulting in superior pain control with reduction of adverse side effects. In addition, use of these agents before the physiologic responses are at their peak results in a superior clinical response. Minimizing soft tissue damage via meticulous surgical technique and adequate exposure is another major component of this protocol. Finally, meticulous periarticular infiltration with the novel injection mixture described produces early potent analgesic and anti-inflammatory effects. This injection forms the core of the advanced multimodal pain protocol described. The results of this prospective randomized clinical trial demonstrate excellent pain relief and functional recovery after and with use of the multimodal protocol described. 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