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Prospective randomized controlled trial comparing standard analgesia with combined intra-operative cystic plate and port-site local anesthesia for post-operative pain management in elective laparoscopic cholecystectomy

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Abstract

Background

Various mechanisms, including somatic and visceral nociceptive stimulation, have been suggested as a cause for pain after laparoscopic cholecystectomy (LC). We therefore conducted a prospective randomized controlled trial (PRCT) to evaluate whether somatovisceral pain blockade reduces pain after LC.

Hypothesis

Analgesic efficacy of multimodal analgesia is superior to standard analgesia for patients undergoing elective LC for symptomatic cholelithiasis. Specifically, topical cystic plate and port-site injection with 0.25 % bupivacaine significantly reduces pain after LC.

Design

This study was designed as single-blinded PRCT.

Setting

This study was conducted in an academic medical center.

Patients and methods

Between February and May 2010 we randomly assigned 63 patients with symptomatic cholelithiasis in a 1:1 ratio to non-opioid/opioid analgesic combinations (Control Group, n = 32) and non-opioid/opioid analgesic combinations plus topical 0.25 % bupivacaine onto the cystic plate and local 0.25 % bupivacaine port-site injection, post-LC (Study Group, n = 31). Primary endpoint was patient-reported pain 1, 4, 6, 12, 24 h and 1 week post-LC using the Visual Analog Scale (VAS 0–10).

Results

Study groups were comparable clinicopathologically. There were no adverse events. A statistically significant reduction in mean pain score was apparent in Study Group patients in comparison with Control Group (mean VAS 4.83 ± 2.33 vs. 6.80 ± 1.87; p < 0.001) at all early (1–6 h) post-operative time points following LC.

Conclusion

This PRCT shows significantly improved pain control with somatovisceral pain blockade over non-opioid/opioid analgesic combinations following LC for symptomatic cholelithiasis. For centers not utilizing adjunctive local anesthetic for LC, this topical use of bupivacaine may improve patient comfort during recovery.

This trial was registered on www.ClinicalTrials.gov NCT# 01972620.

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Abbreviations

ADL:

Activities of daily living

ASA:

American Society of Anesthesiologists

BMI:

Body mass index

CONSORT:

Consolidated standards of reporting trials consensus statement

IRB:

Institutional review board

LC:

Laparoscopic cholecystectomy

NSAIDs:

Nonsteroidal anti-inflammatory drugs

PRCT:

Prospective randomized controlled trial

QOL:

Quality of life

RCT:

Randomized controlled trial

VAS:

Visual Analog Scale

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Acknowledgments

We are grateful to our study biostatistician, Zoran Potic, Dipl. Eng., Agency for Consulting and Management, for his statistical expertise and contributions to this clinical trial.

Funding

This study was supported by the California Oncology Research Institute (CORI).

Author contributions

Veljkovic and Protic were involved in conception and design; Protic, Veljkovic, Popovic, and Kresoja participated in acquisition of data; Popovic and Veljkovic contributed to outcomes assessment and recording; Protic, Veljkovic, Popovic, Kresoja, Avital, and Stojadinovic were involved in analysis and interpretation of data; Protic, Veljkovic, Popovic, Avital, and Stojadinovic drafted the manuscript; Bilchik, Nissan, Avital, and Stojadinovic were involved in critical revision; Protic, Avital, and Stojadinovic provided statistical expertise; Veljkovic, Bilchik, Avital, and Stojadinovic were involved in supervision of the study.

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We certify that all individuals who qualify as authors have been listed; each has participated in one or more of the following areas: conception and design of this work, the acquisition and/or analysis of data, the writing, and/or critical revision of the document, and supervision of this cooperative research effort. All contributing authors approve of the submission of this version of the document and assert that it represents valid work. If information derived from another source was used in this document, we obtained all necessary approvals to use it and made appropriate acknowledgments in the document. All contributing authors take public responsibility for this work.

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Correspondence to Mladjan Protic.

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Drs. Mladjan Protic, Radovan Veljkovic, Anton J. Bilchik, Ana Popovic, Milana Kresoja, Aviram Nissan, Itzhak Avital, and Alexander Stojadinovic have no conflicts of interest or financial ties to disclose.

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Mladjan Protic and Radovan Veljkovic have contributed equally to this study and will share first authorship.

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Protic, M., Veljkovic, R., Bilchik, A.J. et al. Prospective randomized controlled trial comparing standard analgesia with combined intra-operative cystic plate and port-site local anesthesia for post-operative pain management in elective laparoscopic cholecystectomy. Surg Endosc 31, 704–713 (2017). https://doi.org/10.1007/s00464-016-5024-5

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