Local and intra-articular infiltration of bupivacaine before surgery: Effect on postoperative pain after anterior cruciate ligament reconstruction

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<ul><li><p>Local and Intra-articular Infiltration of Bupivacaine Before Surgery: Effect on Postoperative Pain After Anterior </p><p>Cruciate Ligament Reconstruction </p><p>Jt t rgen H6her , M.D. , Dan i e l Kers ten , M.D. , Ber t i l Boui l lon , M.D. , E d w a r d N e u g e b a u e r , Ph.D. , </p><p>a n d T h o m a s T i l i n g , M . D . </p><p>Summary: In a double-blind, randomized trial, 40 patients undergoing open ante- rior cruciate ligament (ACL) reconstruction using a bone-patellar tendon-bone autograft were randomly allocated to two groups: group A (n = 20) received an intra-articular instillation of 20 mL bupivacaine (0.25%) and a local infiltration of 20 mL bupivacaine (0.5%) 15 minutes before surgery. Group B (n = 20) received an injection of saline solution in the same manner. Patient-controlled on-demand analgesia (PCA) with intravenous piritramid was used for postoperative pain con- trol. A significant decrease in pain scores on a visual analog scale (VAS scale, 0 to 10) was found in the bupivacaine group (group A) at bedrest on the day of surgery only (pain score, 5.5 v 7.3 (scale, 0 to 10), P &lt; .05). At all other times, no significant differences were found. The overall supplemental opioid require- ments were not different between the study groups (63.9 v 62.6 mg piritramid/72 hours). A long-lasting, clinically relevant, pain-reducing effect with infiltration of bupivacaine before surgery could not be shown with this study. Key Words: Local anesthetic--Postoperative pain control--Opioid--Patient-controlled analgesia-- Knee surgery--Anterior cruciate ligament. </p><p>A nterior cruciate ligament (ACL) reconstruction using a bone-pate l lar tendon-bone autograft leads to significant postoperative pain, usually in the first 2 days after the operation, m Several methods con- tribute to a reduction in postoperative pain in knee surgery and have been used in the past (Table 1). 3-5 Despite many nonpharmacological methods being helpful in pain reduction, intravenously administered opioids are frequently used for analgesia after sur- gery. 2,6,7 </p><p>From the Division of Trauma Surgery, and the Biochemical and Experimental Division (E.N.), lind Department of Surgery, Univer- sity of Cologne, Ostmerheimer Strasse 200, 51109 Cologne, Ger- many. </p><p>Address correspondence and reprint requests to Jiirgen HOher, M.D., Division of Trauma Surgery, Second Department of Surgery, University of Cologne, Ostmerheimer St200, D-51109, Cologne, Germany. </p><p> 1997 by the Arthroscopy Association of North America 0749-8063/97/1302-149053.00/0 </p><p>Local anesthetics have been shown to be effective for analgesia of the knee for knee arthroscopies with minor surgery. 812 Many investigators suggest the in- stillation of local anesthetics into the knee joint at the end of arthroscopic surgery under general anesthesia for postoperative pain reduction. 13-19 </p><p>Others recommend the application of local anesthe- tics at the beginning of surgery under general anesthe- sia to reduce postoperative pain. 2-24 It is hypothesized that the neural blockade by analgetics or local anesthe- sia prevents the transmission of nociceptor impulses to the central nervous system during and immediately after surgery. Thus, a sustained hyperexictable state in the central nervous system responsible for the mainte- nance of postoperative pain is suppressed. 24-26 Some experimental studies support the effectiveness of this concept, 27'28 whereas others do not. z9 Clinical studies also have controversial results; some show a significant postoperative pain decrease with this procedure 3'31 and some do not. 32-38 In tonsillectomies, herniotomies, and </p><p>210 Arthroscopy." The Journal of Arthroscopic and Related Surgery, Vol 13, No 2 (April), 1997: pp 210-217 </p></li><li><p>L O C A L INTRA-ARTICULAR I N F I L T R A T I O N OF B UPIVA CAINE 211 </p><p>TABLE 1. Methods Used to Reduce Postoperative Pain in ACL Surgery </p><p>Preoperative Patient counselling and encouragement (explanation of the </p><p>procedure, talking about anxiety, mental counselling) Intraoperative </p><p>Pharmacological Local anesthetic infiltration of the wound and knee joint </p><p>before surgery (pre-emptive analgesia) Local anesthetic infiltration of the knee joint at the end of </p><p>surgery Limitation of surgical trauma </p><p>Length of operation/tourniquet time Kind of reconstructive procedure (autograft-allograft) Operative technique (arthroscopic, miniarthrotomy, additional </p><p>lateral incision) Application of wound drainages (size and localization) </p><p>Postoperative Pharmacological </p><p>Regional Femoral nerve block Lumbar plexus block Peridural catheter </p><p>Systemic NSAI-drugs (oral or IV) IV opioids (PCA or nurse-controlled) IM opioids </p><p>Nonpharmocological Local ice application Positioning of the leg, knee immobilizer, wound wrapping Mode of physical activity Patient counselling, placebo effects </p><p>NOTE. See references 3-5. </p><p>orthopaedic foot operations a significant reduction of postoperative pain was shown after infiltration of bupi- vacaine at the beginning of surgery) '21'24 The concept of local infiltration of drugs at the beginning of surgery is still controversial and the subject of contradicting opinions. </p><p>An infiltration of local anesthetics at the beginning of ACL reconstruction has not yet been described in the literature. It was the objective of this study to inves- tigate the effect of local and intra-articular infiltration of bupivacaine at the begin of surgery on the postopera- tive pain in patients undergoing ACL reconstruction. </p><p>PATIENTS AND METHODS </p><p>Study Design and Patient Selection The study was designed as a prospective, controlled, </p><p>double-blind, randomized trial. The study protocol was approved by our local ethical committee (University of Cologne, Germany), and written informed consent was obtained from each patient before surgery. Patients over the age of 18 years who were admitted to our hospital for ACL reconstruction were included into </p><p>the study. Exclusion criteria were spinal anesthesia, a history of chronic drug abuse (analgesics, alcohol, ille- gal drugs), metabolic diseases like diabetes mellitus, liver disease, known allergy against the applied drugs, insufficient knowledge of the German language, disap- proval of randomization, and additional open knee sur- gery. Eleven patients could not be enrolled because of exclusion criteria (spinal anesthesia in 6 cases, a his- tory of illegal drug consumption in 1 case, and addi- tionnal interventions during surgery (medial collateral ligament repair and patellar tendon graft harvesting from the contralateral knee) in 4 cases. Patients suitable for inclusion were informed of the aim and characteris- tics of the study the day before the operation. On the same day, the postoperative pain treatment with a pa- tient-controlled analgesia system (PCA system) was explained to the patient. Forty patients were enrolled into the study and were randomly allocated into two groups. </p><p>Performance of the Study On the morning of the operation, one randomization </p><p>card (dosed envelope) was picked by the operating room nurse. For one group of patients (group A, n = 20), an intra-articular injection (syringe l) with 20 mL bupivacaine 0.25% (Carbostesin; Astra Chemicals, Wedel, Germany) was prepared. A second, subcutane- ous injection (syringe 2) was prepared with 20 mL bupivacaine 0.5%. Another group of patients (group B, n = 20) received an intra-articular and subcutaneous injection with 20 mL saline solution). The intra-articu- lar injection into the lateral superior pouch of the knee was performed by the surgeon after the desinfection of the knee. The knee was then moved through the range of motion three times. With the second injection, the peripatellar tendon tissue, the periosteum of tibia's tubercle, the distal aspect of the patella, and the antero- medial aspect of the proximal tibia were infiltrated. </p><p>For all patients, a standardized anesthetic technique was used. Premedication consisted of midazolam (7.5 rag) orally 1 hour before surgery. General anesthesia was induced with atropine 0.5 mg and thiopentane (4 mg/kg). After administration of succinylcholine and pancuronium, endotracheal intubation was performed. Anesthesia was maintained with isofluorane or fluo- thane and mechanical ventilation. Arthroscopy was performed through an anterolateral and anteromedial portal of the joint. To harvest the patellar tendon graft, an anterolateral incision of approximately 8 to 10 cm was made. The knee joint was opened by incision of the infrapatellar fat pad through the graft defect of the patellar tendon. The tibial bone tunnel was drilled with </p></li><li><p>212 J. HOHER ET AL. </p><p>a 9-mm cannulated reamer over a previously placed k-wire. At the femoral insertion of the ACL, a 40-mm bone tunnel was drilled in an inside-out-direction with a 8-ram cannulated reamer over a previously placed k-wire. Before drilling the femoral tunnel, isometry of the bone tunnels was tested with a house-custom technique. Afterwards, the graft was pulled into the knee joint and the bone blocks were secured with inter- ference screws (7 20 mm, De Puy Corp, Limbach, Germany). Two suction drains (14F and 12F, respec- tively) were inserted into the knee joint and into the subcutanous layer of the anteromedial tibia. After wound closure, an immobilization brace (Stortz Corp, Cologne, Germany) was applied to the knee and in bed the leg was placed at slight elevation. </p><p>Immediately after the end of anesthesia, the patients received the opioids pethidine (Dolantin; Hoechst AG, Frankfurt, Germany) or piritramid (Dipidolor; Janssen GmbH, Neuss, Germany) intravenously for acute pain treatment by our anethesiologists. After discharge from the recovery room to the general ward, intravenous on- demand analgesia was started (PACOM on-demand analgesia computer system; Fresenius AG, Bad Hom- burg, Germany). For on-demand analgesia piritramid (Dipidolor) was used. The pharmacodynamic proper- ties of piritramid are similar to morphine. The demand dose was 2 mg with a pump refractory time of 5 min- utes between valid demands, the maximum dose was set to 60 mg in 16 hours and 90 mg in 24 hours, respectively, s9 The consumption of piritramid was re- corded by the PACOM software system and analyzed by a personal computer. Intravenous on-demand anal- gesia was usually discontinued when no request for pain medication had been made for more than 8 hours. After removal of the wound drains on the second post- operative day, the pain treatment was usually changed to oral analgesic medication with ibuprofen 500 mg orally 3 tablets per day (Imbun; Merckle Corp, Ulm, Germany). </p><p>Study Data and Endpoints Study data included patient age, gender, weight, </p><p>height, and the determination of acute or chronic in- jury. Additionally, the time between bupivacaine infil- tration and inflation of the torniquet, the time interval between infiltration and start of surgery, the length of the operation, and the overall torniquet time and the amount of analgesics applied in the recovery room before PCA-analgesia were documented. </p><p>The primary study endpoints were the intensity of pain assessed by the visual analog scale (VAS) with regard to the level of physical activity (bedrest, ambu- </p><p>TABLE 2. Demographic and Clinical Data of the Study Population </p><p>Group A Group B (n = 20) (n = 20) </p><p>M e ~ SD Mean SD </p><p>Age (yr) 25.2 4.0 25.1 5.3 Height (cm) 179.2 7.8 175.3 7.5 Body weight (kg) 76.2 9.4 72.1 10.4 Time interval: injection to begin </p><p>of tourniquet (min) 8.8 8.0 10.5 5.5 Time interval: injection to begin </p><p>of surgery (min) 14.1 5.1 14.9 4.2 Duration of surgery (min) 117.4 15.8 123.2 26.7 Duration of tourniquet (rain) 110.9 16.7 111.4 28.4 Gender (M/F) 17:3 14:6 Type of injury (acute/chronic) 8:12 7:13 </p><p>NOTE. Group A, bupivacaine group; group B, saline group (con- uol). No statistical differences were determined between the study groups. SD, standard deviation. </p><p>lation, physical therapy) and the requirements of anal- gesics. </p><p>Pain intensity was assessed with a modified VAS that consisted of 11 continuously lined up boxes an- chored by two extreme pain values ("no pain" and the other "worst pain imaginable"). The patients were asked to mark the actual intensity of pain with the related kind of physical activity every 2 hours on a prepared sheet. Thus, a continuous intensity of pain profile could be drawn for the postoperative period. For comparative analysis, the maximum perceived pain during the day at bedrest, during ambulation, and dur- ing physiotherapy was documented by the patient on a VAS in the evening of days 0, 1, 2, 3, and 7 after surgery on a separate sheet. </p><p>The consumption of analgesics was documented ex- actly by the PCA software regarding time and amount of medication. By means of computer protocol analy- sis, interval consumption rates were calculated during the first 6 hours after the operation, and until the morn- ing and the evening (8 AM and 8 PM) of each day after surgery, until the PCA application was discontinued. Additionally, the overall consumption of analgesics was calculated for each patient with regard to body weight. To compare different pain medication, equiva- lent doses for tramadole and pethidine were calculated. Additionally, the patient was asked to report side ef- fects and the localization of pain at the evening of every day with intravenous analgesic application. </p><p>Statistics For an estimated reduction of pain intensity of 1.5 </p><p>according to VAS (range, 0 to 10; standard deviation, </p></li><li><p>LOCAL INTRA-ARTICULAR INFILTRATION OF BUPIVACAINE 213 </p><p>&lt; &gt; </p><p>10 </p><p>9 </p><p>8 * </p><p>7 , m </p><p>6 - - - </p><p>4 </p><p>3 </p><p>2 </p><p>1 </p><p>0 l 0 </p><p>days after surgery </p><p>2 </p><p>bupivacaine </p><p>m saline </p><p>3 // 7 </p><p>FIG 1. Intensity of Pain at bedrest: max imum score (VAS) during the day. *Mean of bupivacaine group significantly different than mean of saline group (P &lt; .05). </p><p>O3 &lt; &gt; </p><p>10 </p><p>9 </p><p>8 </p><p>7 </p><p>6 </p><p>5 </p><p>4 </p><p>3 </p><p>2, </p><p>0 I </p><p>days after surgery </p><p>I 2 3 </p><p>bupivacaine </p><p>m saline </p><p>ill // 7 </p><p>F IG 3. Intensity of Pain during physical therapy: maximum score during the day. Score numbers missing at the day of the operation because no regular physical therapy was performed. </p><p>1.5) the sample size was calculated to be 17 patients per group for an alpha-error of 0.05 and a beta error of 0.20. In the final study protocol, the desired number of patients per group was set at 20. </p><p>Data were analyzed by a statistical package on a personal computer (Stat View; Abacus Concepts Inc, Berkely, CA). Groups were compared using rank tests (Mann-Whitney U-Test) for pain intensity data and continuous variables. Values of P &lt; .05 were consid- ered significant. </p><p>RESULTS </p><p>Demographic and Clinical Data Table 2 shows the personal and clinical data of the </p><p>patients. There were no significant differences found </p><p>10 ' ' " ;sine </p><p>9 </p><p>8 </p><p>7 </p><p>6 O3 &lt; 5 &gt; </p><p>4 </p><p>3 </p><p>2 </p><p>1 </p><p>0 1 2 3 7 </p><p>days after surgery </p><p>FIG 2. Intensity of Pain when getting out of bed: maximum score (VAS) during the day. Score values missing at the day of the opera- fion because patients usually did not get up. </p><p>between study groups (P &gt; .05, Mann-W...</p></li></ul>


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