Pain control in laparoscopic surgery: a case–control study between transversus abdominis plane-block and trocar-site anesthesia

Abstract

Local anesthesia in laparoscopic operations is gaining increasing consensus. To standardize analgesia, a prospective case–control study was created over a 1-year period, in collaboration with the anesthesiology service in our community hospital. Starting from February 2016, we prospectively enrolled adult patients (more than 16 years old) undergoing laparoscopic appendectomy or cholecystectomy, either in emergency or elective setting. Patients were preoperatively assigned (based on the chart-admission number) either to transversus abdominis plane (TAP) block treatment (Group 1—experimental arm) or trocar-site anesthesia (TSA) (Group 2—experimental arm), and then compared with group of patients not submitted to treatment (Group 3—control arm). Demographic and clinical characteristics of each patient were recorded. Post-operative pain level (primary outcome) was assessed with visual analog scale (VAS) score; analgesic use and length of stay in hospital were defined as secondary outcomes. Forty-two patients were assigned to TAP block treatment (Group 1), fifty-two to TSA (Group 2), and thirty-nine underwent no pre-incisional treatment (Group 3). In the comparison between patients undergoing TAP block or TSA with the control arm, a significance difference in reported pain was recorded in every scheduled time (p < 0.05 at 0, 6, 12, 18, 24, and 48 h from awakening). Both local anesthesia groups share a benefit in terms of primary outcome. The use of pre-incisional TSA for all the patients undergoing laparoscopic cholecystectomy and appendectomy could become a routine practice to reduce post-operative pain both in the elective and emergency setting.

Introduction

Local anesthesia in laparoscopic operations is gaining increasing consensus due to the previous studies which demonstrate a better pain control in the post-operative period, thus permitting an earlier discharge from hospital [1, 2]. Laparoscopic cholecystectomy and laparoscopic appendectomy are two of the most performed operations in a general surgery community practice, and require a short post-operative stay, being they even performed in a day-case asset. The actual standard of care does not yet consider pre-emptive local anesthesia for these cases. To standardize analgesia, a prospective case–control study was created over a 1-year period, in collaboration with the anesthesiology service in our community hospital.

Materials and methods

Starting from February 2016, we prospectively consecutively enrolled adult patients (more than 16 years old) undergoing laparoscopic appendectomy or cholecystectomy, either in emergency or elective setting. Exclusion criteria were neuromuscular or neurodegenerative disease, allergy to local anesthetics, dementia, or other impairments compromising pain description.

Patients were submitted either to transversus abdominis plane (TAP) block treatment (Group 1—experimental arm), trocar-site anesthesia (TSA) (Group 2—experimental arm), or no treatment (Group 3—control arm).

All patients received general anesthesia with endotracheal intubation. A standard multimodal intraoperative intravenous analgesic regimen was used including 1 g of paracetamol and 30 mg of ketorolac. All the operations were performed by surgeons trained in laparoscopy. Standard trocar position included for appendectomy three trocars in umbilical (10 mm, open access), left iliac fossa (5 mm), and supra-pubic (5 or 10/12 mm) areas (Italian position), and for cholecystectomy, four trocars in umbilical (10 mm, open access), left hypochondrium (10/12 mm), sub-xyphoideal (5 mm), and right flank (5 mm) areas (French position).

The experimental arms consisted in a total of 30 mL of 0.375% levobupivacaine injected in divided doses either in the midaxillary line between the costal margin and the iliac crest for Group 1 in the trocar sites for Group 2, both before skin incisions.

In cohort 1, the TAP block was performed using a posterior approach under ultrasound guidance by anesthesiologists with a significant experience with this technique (more than 20 procedures). A high-frequency linear ultrasound probe was positioned in a transverse plane on the anterolateral abdominal wall in the midaxillary line, between the lower costal margin and the iliac crest both on the left side and the right side (Petit’s triangle). Then, a 20-gage 10-cm needle was inserted in the plane of the ultrasound beam and followed visually until it reached the plane between the internal oblique and the transversus abdominis muscles. Two milliliters of the local anesthetic solution were injected to visualize the spread of the solution in the correct plane (“biconvex lens” image) and confirm correct needle position after which the remainder of the 30 mL was administered.

In cohort 2, the surgeon performed infiltration of anesthetic under direct vision for the first trocar entry (open or Hasson technique) in two injections, one in the subdermal tissue before skin incision and the other in the fascial plane before fascial incision. In the remaining 2 or 3 trocars injection was at first subcutaneous in the place of subsequent skin incision, and afterwards, the needle was advanced to the level of the pre-peritoneal space under direct laparoscopic vision: slow injection was performed to tent the peritoneum, and then, the needle was slightly withdrawn to infiltrate the transversus abdominis plane. A diffuse bulge could be visualized expanding anterior to the peritoneum and muscles.

All treatments were performed at the beginning of the surgical procedure and immediately after the intubation. In all patients, the total amount of anesthetic used did not exceed the recommended safe dose of 2.5 mg/kg. Careful aspiration was performed prior to all injections to minimize the risks of intravascular entry and subsequent local anesthetic toxicity.

In cohort 3, no local anesthesia was administered preoperatively, and followed a standard care anesthetic perioperative regimen.

Throughout the post-operative period of all patients, analgesic medication (Ketorolac) was administered on demand in adjunction to a scheduled administration of Paracetamol (1 g every 8 h for the first 24 h). Opioids are considered contraindicated in Italian regulatory rules for gallbladder diseases, and, thus, were not used in our study. Post-operative abdominal pain was assessed at 0 (t0), 2 (t1), 6 (t2), 12 (t3), 24 (t4), and 48 (t5) h from awakening. Each patient received thromboembolism prophylaxis with low-molecular-weight heparin, as required by our institutional protocol for each laparoscopic intervention. During the hospital stay, the nursing staff (blinded in concern to the performed anesthetic treatment) completed all timed assessments.

Patients were asked to subjectively quantify their abdominal pain level using a 10-point visual analog scale (VAS), a simple and validated measure of pain ranging from 0, representing no pain, to 10, representing the worst pain imaginable.

Intraoperative and post-operative analgesic administrations were analyzed, together with demographic and surgical data of each patient, including age, sex, American Society of Anesthesiologists physical status classification, associated diseases, type of surgical operation (appendectomy or cholecystectomy, elective or emergent), operative skin-to-skin time, and length of stay in hospital. In addition, TAP block and TSA procedure time was recorded. The sites of injection of the TAP block and the trocar sites were inspected for hematoma formation or signs of infection.

The primary outcome of the study was the difference in patient-reported pain scores between treated and control patients. Secondary outcomes included total analgesic consumption and local or regional anesthesia-related time and complications.

The study was approved by Surgical Clinic Department.

Statistical analysis

We based the sample size calculation on the assumption that a two-point difference in VAS pain scores would be clinically meaningful. A sample size of 34 patients in each cohort would have been able to detect a difference of 2.0 points in pain score with a power of 80% and a type 1 error (alpha) of 0.05 using a two-tailed test, assuming the SD of the differences to be 4.

Normally distributed continuous variables were described as means with ranges (minimum–maximum). Means were compared between study groups using a Student t test. Differences in mean pain scores between TAP versus infiltration, between TAP versus controls and between infiltration versus controls, were estimated with 95% confidence intervals, and paired t tests were used to test whether the difference in pain scores at each follow-up time was equal to zero. Categorical data were expressed as percentages and then compared between groups using a Chi-square test. P value was considered statistically significant if < 0.05.

Statistical analyses were performed using Microsoft Excel for Windows®.

Results

Between February 2016 and March 2017, 133 patients following inclusion criteria were enrolled in the study.

Forty-two patients were assigned to TAP block treatment (Group 1), fifty-two to TSA (Group 2), and thirty-nine underwent no pre-incisional treatment (Group 3).

There was no significant difference between the three groups of patients with respect to age, sex, American Society of Anesthesiologists physical status, type of surgical treatment, and operative time, as shown in Table 1. The majority of patients were submitted to cholecystectomy (100 patients, 75%) without any statistically significant difference in distribution among three groups (p = 0.19). About 40% of patients were submitted to surgery in emergency setting without any statistically significant difference between three groups, as shown in Table 1. Among these patients, each one had acute cholecystitis or appendicitis without any signs of severe sepsis or hemodynamic instability.

Table 1 Characteristics of patients and surgical procedures

In all patients, the TAP block was easily performed on both abdominal sides, and there were no described complications with either approach. Upon inspection, the sites of injection revealed no bruising, hematomas, swelling, or infection. There were no reported anaphylactic reactions or episodes of toxicity. Mean TAP block procedure time was 9 min (range 4–15). Mean time for TSA was 1.5 min (range 1–2).

Comparing Group 1 with Group 2, there was no significant difference in reported pain when asked at 0, 6, 12, 18, 24, and 48 h from awakening, as illustrated in Table 2.

Table 2 Comparison of mean pain scores (primary outcome)

On the contrary, in the comparison between patients undergoing TAP block or TSA with the control arm, a significance difference in reported pain was recorded in every scheduled time (p < 0.05 at 0, 6, 12, 18, 24, and 48 h from awakening). Both local anesthesia groups share a benefit in terms of primary outcome (Table 2 and Fig. 1).

Fig. 1
figure1

Post-operative pain (DPO)-primary outcome

Concerning post-operative analgesic therapy, Group 3 patients demanded more rescue doses of Ketorolac to control post-operative pain than patients treated with TAP block (Group 1) or with TSA (Group 2), as described in Table 3. Instead, no significant difference was recorded between Group 1 and Group 2 on the need for further analgesic therapy.

Table 3 Secondary outcomes

Finally, the length of stay in hospital was on average 5 days (range 2–13) for Group 3 patients, 3 days (range 2–6) for Group 1 patients, and 3 days (range 1–7) for Group 2 patients with a statistical significant difference comparing Group 1 with Group 3 (p < 0.05) and Group 2 with Group 3 (p < 0.05). For other parameters, no difference between Group 1 and Group 2 was observed (p = 0.56).

Discussion

This study demonstrates that, amongst the good practices in general surgery, in particular for those operations which account for most of the activity, like appendectomy and cholecystectomy, pre-operative local anesthesia could become the standard behavior for all surgeons. The significant difference between the former two groups and the control group enhance the reduction in post-operative pain (measured in the first 48 h, which comprehend most of the in hospital stays), less need for rescue analgesics and consequent faster discharge from hospital. These data confirm the previous results in the literature [3,4,5,6,7,8,9], especially a recent meta-analysis of four studies [10] which collected data from randomized-controlled studies regarding open surgery and mostly gynecologic operations.

In particular, referring to gynecological setting, two randomized-control trials have been published: El Hachem et al. [11] stated that there were no statistically significant difference between transversus abdominis plane-block versus trocar-site infiltration in reducing post-operative pain, as demonstrated in our study. Tam et al. [12] concluded that the post-operative injection of bupivacaine in trocar port sites did not significantly improve pain scores after laparoscopic gynecologic surgery. This finding could be considered in contrast with our results, but, in our protocol, we performed the injection at the beginning of the intervention.

Other comparative studies have been published [13, 14] even if this study is the better “powered” and focused on general surgical practice. Still, the pre-emptive anesthetic treatment has not yet been standardized in guidelines [15]. In consideration of the fact that several recommendations (also those of the World Health Organization) concerning good clinical practices in post-operative pain establish the cut-off of 4 in the VAS pain score as “tolerable”, a pre-emptive local or loco-regional anesthesia can lower the threshold to two or less. For the difference between TAP and TSA, both seem to achieve consistent pain reduction in comparison to control group. The former though requires, at least in our ward, specific skills (generally performed by trained- anesthesiologists), specific instrumentation (ultrasound always disposable in theater), and costlier disposable devices (injection needles and cannulas), and is more time-consuming (a significant difference has been found in comparison with TSA), especially in this specific setting (relatively “fast” operations), in which the median time-consumption was 16% of the total operating time. Moreover, TSA is easily performed also in the sub-xyphoideal 5 mm incision which seems not to be covered by TAP. In fact, some authors prefer subcostal TAP block or rectus sheath TAP block instead of posterior TAP for these applications [16]. Both procedures have more efficacy when applied before any skin incision, as demonstrated by the previous studies [17].

The role of TAP in contemporary practice, however, remains limited, as suggest by a systematic review [18].

Moreover, the other studies demonstrated the efficacy of trocar-site anesthesia in reducing post-operative pain and medication costs [19, 20]. In consideration of our results, supported by the literature available, we have abandoned TAP block in our routine practice in favor of TSA: we have limited the indication to TAP block (mainly subcostal) to laparoscopic ventral hernia repair, in which the fixation of the mesh cannot be covered properly by infiltration anesthesia.

The analysis of the secondary outcomes proves that the beneficial effect of less perceived pain can help patients’ mobilization, ileus and return to normal feeding, and pulmonary and cardiac complications. Moreover, the collateral effects of NSAIDs (gastric pain, gastrointestinal and surgical bleeding) are minimized, even if the statistical proof of these complications would require much larger cohorts of patients or prospective non-comparative studies.

The reduction of pain medication need of our study is confirmed in a randomized-controlled trial of cholecystectomy intervention [21]: the authors concluded that trocar-site local anesthetic infiltration is more effective for post-operative analgesia, easier to apply and safer than other analgesia methods. Morphine consumption is lesser and side effects are fewer; therefore, this method can be used as a part of common practice”.

The choice of levobupivacaine as injection anesthetic is based on the recent literature data confirming a low systemic toxicity and an equivalent anesthetic potency compared to the other pure left-isomers (ropivacaine) or racemic compounds (bupivacaine) [22].

As additional results, following the concept of “yellow island” as reported in the literature [23], we did not observe any inferior epigastric damage during trocar positioning.

Moreover, we did not observe any post-operative complications related to thromboembolism. Our institutional protocol in fact requires that each patient undergoing laparoscopic surgery needs thromboembolism prophylaxis with low-molecular-weight heparin, even though its role is debated in the literature [24, 25].

The choice of appendectomy and cholecystectomy as the surgeries of choice for this study was taken in regard to frequency (they are frequently performed in most clinical practices, also in community or rural hospitals) but also to the fact that major laparoscopic abdominal operations (especially colectomy, gastrectomy, and obesity surgery) generally require an epidural analgesia for the control of post-operative pain and to fulfill the ERAS (Enhanced Recovery After Surgery) protocols.

In conclusion, we recommend the use of pre-incisional TSA for all the patients undergoing laparoscopic cholecystectomy and appendectomy as a routine practice to reduce post-operative pain both in the elective and emergency settings.

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Correspondence to Sarah Molfino.

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Molfino, S., Botteri, E., Baggi, P. et al. Pain control in laparoscopic surgery: a case–control study between transversus abdominis plane-block and trocar-site anesthesia. Updates Surg 71, 717–722 (2019). https://doi.org/10.1007/s13304-018-00615-y

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Keywords

  • Pain control
  • Laparoscopic surgery
  • Post-operative pain
  • TAP block
  • Trocar-site anesthesia