|Year : 2014 | Volume
| Issue : 2 | Page : 111-116
The effect of fascia iliaca compartment block versus gabapentin on postoperative pain and morphine consumption in femoral surgery, a prospective, randomized, double-blind study
Abdolreza Najafi Anaraki1, Kamran Mirzaei2
1 Department of Anaesthesiology and Intensive Care Unit, Faculty of Medicine, Bushehr University of Medical Sciences, Bushehr, Iran
2 Department of Community Medicine, Faculty of Medicine, Bushehr University of Medical Sciences, Bushehr, Iran
|Date of Web Publication||20-May-2014|
Department of Community Medicine, Faculty of Medicine, Bushehr University of Medical Sciences, Rishehr, Bushehr
Source of Support: None, Conflict of Interest: None
Background and Objective: Pain, after orthopedic surgery, is a severe and leading cause of chronic pain with many attempts to reduce it without a total success. Gabapentin is effective in reducing acute and chronic pain. Fascia iliaca compartment block (FICB) is a simple, rapid, effective, and safe method of achieving excellent pain relief. The purpose of this study is to compare effect of pre-emptive gabapentin with FIC on reducing postoperative pain and morphine consumption in femoral surgery. Materials and Methods: Seventy-eight patients scheduled for elective open reduction internal fixation of femur were enrolled in the study and separated into two groups. The control group received 600 mg of gabapentin orally two hours before surgery and the case group received FICB under general anesthesia. Data, including blood pressure, heart rate, sedation score, visual analogous scale at several hours and first need to analgesic post operatively was collected. Results: The post operation pain in FICB group was significantly lower than gabapentin group (P = 0.000). Patients in FICB group had more of postoperative satisfaction and the time of first need of analgesic and total analgesic consumption was significantly lower than gabapentin group (P < 0.05). There were no significant differences in complications among the study groups. Conclusion: Fascia iliaca compartment block is a safe, low skill and inexpensive way to reduce postoperative pain after femur surgery in the first hours of postoperative and can be a part of multi-modal therapy with no side effects.
Keywords: Fascia iliaca compartment block, femur surgery, gabapentin, postoperative pain
|How to cite this article:|
Anaraki AN, Mirzaei K. The effect of fascia iliaca compartment block versus gabapentin on postoperative pain and morphine consumption in femoral surgery, a prospective, randomized, double-blind study. Indian J Pain 2014;28:111-6
|How to cite this URL:|
Anaraki AN, Mirzaei K. The effect of fascia iliaca compartment block versus gabapentin on postoperative pain and morphine consumption in femoral surgery, a prospective, randomized, double-blind study. Indian J Pain [serial online] 2014 [cited 2020 Sep 22];28:111-6. Available from: http://www.indianjpain.org/text.asp?2014/28/2/111/132852
| Introduction|| |
Pain after femoral surgery is moderate to severe and pain management after it is a major concern. , It can affect heart, lung, wound healing, postoperative immune function and rehabilitation.  Postoperative pain is treated basically by intravenous opioid, patient controlled analgesia (PCA) with several unwanted side effects , and some kind of pain is not fully responsive to opioid therapy.  Gabapentin is a structural analogous of gabaaminobuteric acid that was introduced in 1990 and used to treat chronic pain.  Gabapentin has some effects on nociceptive pain involving central sensitization.  Some studies show effect of gabapentin in reducing post operative pain and morphine consumption after the surgery. , A new single injection procedure, the fascia iliaca compartment block (FICB) for blocking the femoral, lateral cutaneous was described by Dalens et al., on children and is a low skill and inexpensive method of preoperative pain reliever without any need for use of nerve stimulator.  This nerve block may be performed before induction, during the course of anesthesia, or after emergence.  The technique consists of injecting local anesthetics behind the fascia illica at the union of the lateral with the two medial thirds of the inguinal ligament, and forcing it upward by finger compression.  There is no clinical trial to investigate the effects of gabapentine and fascia iliaca block on postoperative pain and morphine consumption. The primary aim of our study was to investigate the effects of gabapentin and fascia iliaca block on pain score and morphine consumption after femoral shaft surgery. Secondary aim consists of side effects and patient's satisfaction.
| Materials and Methods|| |
This randomized double-blinded clinical trial was conducted between May 2012 and September 2013 in our educational hospitals and was approved by the ethics committee of our University and is registered at the Clinical Trials.gov database (reference no. IRCT201203021936N9). This study was performed according to the requirements of the declaration of Helsinki. After obtaining the informed consent from 78 patients (American Society of Anesthesiologists (ASA) physical statuses I to III) scheduled for elective open reduction internal fixation of femur were enrolled in the study. Patients between the ages of 15 and 45 years and of ASA physical statuses I-III were eligible for the study. Patient with contraindications to nerve block or to any study medication, peripheral neuropathy, simultaneous fracture of other bones, hepatitis, chronic use of gabapentin or opioid, patients with psychological problem and duration of surgery more than 3 hours were excluded. ,, Patients were randomly divided to two equal groups (n = 39) with a computerized random number generator. Patient in gabapentin group (control group) received 600 milligram of gabapentin capsule orally by the nurse staff who were not involved in study two hours before surgery. In fascia illica block group (case group) patients received lactose capsule in same color as that of the capsules given to control group by nurse staff, not involved in study two hours before the surgery. Patient demographic data including weight, age and duration of surgery were recorded. The routine monitoring was designed to be entirely identical in both the study groups. All the patients in both experimental and control groups were catheterized with IV line 18-gauge and received 500 ml of normal saline solution before induction of anesthesia. All patients in both the groups were given a premedication with 1 mg of IV midazolam. All patient in case and control groups received general anesthesia by injection of thiopental sodium (4 mg/kg) plus atracurium (0.6 mg/kg) and fentanyl (3 μg/kg). All patients were intubated by intrathecal tube size number 7.5 and the anesthesia maintenance in both groups were accomplished by using IV infusion of propofol and atracurium in order to have a normal PaCO 2 , the tidal volume and respiratory rate, which were kept at 10 mL/kg and 10 per min, respectively. It is of note that the FiO 2 in both the groups were the same (50%). Fascia illiaca compartment block was performed at the side of operation in case group under general anesthesia before surgery as described by Dalens et al., to block the femoral and the lateral femoral cutaneous nerves.  The injection is administered approximately 1 cm below the inguinal ligament, at the junction of the lateral third and the medial two thirds of a line that joins the pubic spine to the anterior superior iliac spine. After the short bevel needle traverses the skin, two pops are felt. The first corresponds to the fascia lata, the second to the fascia illiaca. A loss of resistance is experienced later. Forty milliliters of bupivacaine, 0.5%, was injected.
Morphine (0% 01 mg. kg) was given to all patient 20 minutes before the end of surgery. Neuromuscular blockage was antagonized with neostigmine (0% 4 mg.kg) plus atropine (0% 2 mg.kg) at the end of surgery. All the patients were transferred to the post anesthetic care unit and routine monitoring was done. Patient transferred to ward with aldrete score of 9.  In accordance with Dahlgren, a 100 mm Visual Analog Scale (VAS) (o = no pain.100 = the worst imaginable pain) was used post operatively to assess pain on rest and after coughing.  The degree of sedation was assessed in five-point scale: 1 = fully awake and oriented, 2 = drowsy, 3 = eyes closed but arousable to command, 4 = eyes closed but arousable to mild physical stimulation and 5 = eyes closed but unarousable to mild physical stimulation.  Sedation grade 3 and 4 are considered as 'deep sedation'.
Postoperative analgesia consisted of PCA with i.v. morphine. The settings were 2 mg bolus, 15 min lockout time, and a maximum hourly limit of 7 mg if VAS of the patients were more than 4 after 30 minute of postanaesthesia care unit (PACU) admission, the incremental dose of morphine (1 mg.ml) was injected by staff of the wards. Patients were evaluated in PACU and ward and 2, 4, 6, 12 and 24 hours postsurgery for pain score, heart rate (HR), partial oxygen saturation (Spo 2 ), blood pressure (BP), respiratory rate, level of sedation and total dosage of morphine use by anesthesiologist not involved in the study. Side effects such as respiratory depression nausea and vomiting, somnolence, pruritus and dizziness were recorded. Opioid was stopped if the patient had a respiratory rate less than 10 breaths per minute, oxygen saturation measured by pulse oximetry less than %95 or Sedation grade 3 and 4. Nausea and pruritus were assessed on modified four point ordinal scales (0 = absent, 1 = mild, 2 = moderate, 3 = severe). 
Pruritus was treated with diphenhydramine 25 mg IV. Sustained nausea or vomiting lasting longer than 4 min treat by ondansetron (4 mg IV). Satisfaction with pain management was assessed by numerical rating scale (NRS) from 0 to 10 (0 = not satisfaction, 10 = completely satisfied). 
Calculations and analyses were done using the Statistical Package for the Social Sciences software (SPSS version 16.0 for Windows, Chicago, IL, USA, 2011). Univariable statistics (eg., mean, median and frequency ) were used to assess the distribution of data for each variable. Mann-Whitney test were used to compare differences between groups with statistical significance defined as P < 0 .05.
| Results|| |
There was no significant difference between groups in terms of demographic and surgical data [Table 1]. The systolic and diastolic blood pressure, amount of Pulse Rate, O2 saturation, time of surgery were equal in groups after each time interval (P > 0.05).
The VAS showed significant difference between gabapentin group FICB group at 2, 4 and 6 hours postoperation and after patients transferred to PACU. (P = 0.000, P = 0.000, P = 0.001 and P = 0.000, respectively). VAS in these hours was significantly lower in FICB group than in gabapentin group [Figure 1] but at 12 and 24 hours postoperation, the VAS showed no significant difference.
The mean time of first need analgesic and total analgesic consumption postoperation in gabapentin group and FICB group were showed in [Table 1]. The time of 1 st need analgesic and total analgesic consumption in FICB group was significantly lower than gabapentin group.
There were no significant differences in complications among the study groups.
The median level of patients' satisfaction postoperation in FICB group was significantly higher than gabapentin group (6.00 and 7.00, respectively, P = 0.001).
| Discussion|| |
Result of our study showed that FICB is a safe method, with low postoperative complications and an acceptable patient satisfaction to reduce postoperative pain in patients, whohad undergone femur surgery and can be a part of multimodal therapy with no side effects. Unfortunately, there are no clinical trials that compare the effect of FICB and gabapentin on postoperative pain.
Wathen, Joe E  compare FIC nerve block with intravenous morphine sulfate for the initial pain management of femur fracture patients presenting to a pediatric emergency department. They used a prospective, randomized, unblinded, controlled trial on children (fifty-five patients) aged 15 months to 18 years, with acute femur fractures. Patients were randomized to receive intravenous morphine sulfate or a fascia iliaca compartment nerve block with ropivacaine (Naropin). Pain scores were recorded at initial analgesic administration (baseline), at 5, 10, 15, 30, and 60 minutes, and then every hour up to 6 hours from baseline by trained nursing observers and the research baseline pain score was similar (9.4 FIC nerve block and 9.5 morphine sulfate). Pain score at 30 minutes after initial treatment was 5.87 for FIC nerve block, and 7.54 for morphine sulfate, with a difference of 1.67 in pain reduction between the 2 groups, according to the average baseline score of 9.45. Similar lower pain scores were observed in the FIC nerve block group as early as 10 minutes from baseline and throughout the 6-hour duration of the study. Patients who received a FIC nerve block showed lower scores by approximately 15% compared with patients who received morphine sulfate. Median duration of analgesia was longer in the FIC nerve block group compared with that in the morphine sulfate group (313 minutes versus 60 minutes). Fewer additional medications were given to patients, who received the FIC nerve block. Any complications related to nerve block has occurred. They concluded FIC nerve block provided clinically superior pain management compared with intravenous morphine sulfate at 30 minutes from baseline and throughout the initial 6 hours of medical treatment of children 16 months to 15 years, who had isolated acute femur fractures. Findings of this study confirm lower pain score at PACU and at first six hours after surgery.
Yun, M. J.  studied 40 patients (n = 20) in a prospective randomized trial and compared the analgesic effect of a FICB with intravenous (i.v.) alfentanil when administered to facilitate positioning for spinal anaesthesia in elderly patients undergoing surgery for a femoral neck fracture. Patients in alfentanil group (IVA) received a bolus dose of i.v. alfentanil 10 μg/kg, followed by a continuous infusion of alfentanil 0.25 μg/kg/min starting 2 min before the spinal block, and FIC received a FIC block with 30 ml of ropivacaine 3.75 mg/ml (112.5 mg) 20 min before the spinal block. They compared VAS scores, time to achieve spinal anesthesia, quality of patient positioning, and patient acceptance. VAS scores during positioning were lower in the FIC group than in the IVA group and time to achieve spinal anesthesia was shorter in the FIC group. Patient acceptance was also better in the FIC group than in the IVA group. They concluded FIC block is more efficacious than i.v. alfentanil in terms of facilitating the lateral position for spinal anesthesia in elderly patients undergoing surgery for femoral neck fractures. The results of this study confirmed our findings.
Monzon et al.,  studied 63 adult emergency patients (43 women, 20 men; ages 37-96 years, mean 73.5 years) with radiographically diagnosed hip fractures. They inserted a 21 g, 2-inch intramuscular injection needle to do fascia iliaca block. They injected 0.3 ml/kg of 0.25 bupivacaine after loss of resistance was felt (fascia lata and fascia iliaca). They tested the block's efficacy by assessing sensory loss. Pain assessments were done with VAS before, and at 15 min, 2 hours, and 8 hours post-block. Post-procedure pain was reduced in all patients, but not completely abolished in any. The average pain before block was 8.5 (ranged from 2 to 10 points) using the VAS; at 15 min post-injection, it ranged from 1 to 7 points (average 2.9); at 2-h post-injection, it ranged from 2 to 6 points (average 2.3); at 8-h post-injection, it ranged from 4 to 7 points. They found FICB as a simple, rapid, effective, and safe method of achieving excellent pain control in emergency department Short, J et al.,  studied effects of 300 or 600 mg oral gabapentin, or placebo on post operative pain after delivery. One hundred thirty-two women were randomized in this study. Pain assessments at rest and on movement (VAS 0 to 100 mm) were recorded at 6, 12, 24, and 48 hours after surgical incision. Pain on movement at 24 hours was recorded. Patient satisfaction with analgesia, supplemental opioid consumption, lactation difficulties, neonatal outcomes, maternal sedation, and other adverse effects were recorded. Result showed no obvious difference between groups. They concluded a single preoperative dose of gabapentin (300 mg and 600 mg) was not adequate to improve post-cesarean analgesia compared to placebo in the context of a multi-modal analgesic regimen and a larger study is required. The findings of this study are against us. Finding of this study explains no difference between case and control groups in pain score at 12 and 24 hours postoperatively.
The effect of preoperative administration of gabapentin on postoperative pain investigated in a systematic review (meta-analysis) included 12 randomized controlled trials of 896 patients undergoing a variety of surgical procedures.  This study showed VAS for pain at 4 hours and 24 hours were significantly less in those patients who received gabapentin. Opioid usage by those patients who received gabapentin also decreased. Gabapentin administration was associated with more sedation and anxiolysis, but not associated with a difference in light headedness, dizziness, nausea, or vomiting. Based on this systematic review, authors concluded that pre-operative oral gabapentin is a useful adjunct for the management of postoperative pain that provides analgesia through a different mechanism than opioids and other analgesic agents and would make a reasonable addition to a multimodal analgesic treatment plan. The finding of this study are against us.
Bang SR et al., performed a randomized, double-blinded, placebo-controlled study to determine the effect of low-dose gabapentin on postoperative pain management in patients undergoing arthroscopic rotator cuff repair.  They divided 46 patients (n = 23) into two groups according to the drug administered two hours before surgery, either 300 mg of gabapentin or placebo. They measured the VAS score at 2, 6, 12, and 24 hours postoperatively, fentanyl consumption and side effects during the first two hours in the post-anesthesia care unit and then at 6 and 24 hours, postoperatively. The patients also were evaluated for side effects including nausea, vomiting, respiratory depression, dizziness, drowsiness, voiding difficulty, and pruritus. The VAS scores at 2, 6, and 12 hours postoperatively were significantly lower in the gabapentin group than in the placebo group. The consumption of fentanyl, over a period of 24 hours, was not different in the comparisons between the groups. The incidence of side effects was similar in the 2 groups. They concluded a single dose of 300 mg of gabapentin reduced the VAS score during the first 24 hours postoperatively in patients undergoing shoulder arthroscopic rotator cuff repair, without significant side effects when compared with placebo. However, the fentanyl consumption did not differ between the gabapentin and placebo groups.
In an active placebo-controlled, double blind, randomized study the hypothesis that gabapentin reduces the postoperative need for additional pain treatment (postoperative opioid sparing effect of gabapentin in humans) had been tested.  They gave 1200 mg of gabapentin or 15 mg of oxazepam (active placebo) 2.5 h prior to induction of anesthesia to patients undergoing elective vaginal hysterectomy. Gabapentin reduced the need for additional postoperative pain treatment (PCA boluses of 50 μg of fentanyl) by 40% during the first 20 postoperative hours. During the first 2 postoperative hours pain scores at rest and worst pain score (VAS 0-100 mm) were significantly higher in the active placebo group compared to the gabapentin-treated patients. Additionally, pretreatment with gabapentin reduced the degree of postoperative nausea and incidence of vomiting/retching possibly either due to the diminished need for postoperative pain treatment with opioids or because of an anti-emetic effect of gabapentin itself.
We had one limitation in our study as it was not possible for us to use ultrasonography and did more accurate injection. It could affect pain score at 12 and 24 post operatively.
| Conclusion|| |
Pre-emptive use of FICB is a safe, low skill and inexpensive method way to reduce postoperative pain, especially in first hours postoperatively and reduce morphine consumption in elective open reduction internal fixation of femur surgery and can be one part of multimodal therapy with no side effects.
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