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Ultrasound-guided subcostal transversus abdominis plane blocks with liposomal bupivacaine vs. non-liposomal bupivacaine for postoperative pain control after laparoscopic hand-assisted donor nephrectomy: a prospective randomised observer-blinded study

Anaesthesia. 2016 Aug;71(8):930-7 doi: 10.1111/anae.13502.

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Ovid Technologies, Inc.

Abstract

We compared the effect of subcostal transversus abdominis plane (TAP) block with liposomal bupivacaine to TAP block with non-liposomal bupivacaine on postoperative maximal pain scores in patients undergoing donor nephrectomy. Sixty patients were prospectively randomly assigned to receive ultrasound-guided bilateral TAPs with either 1.3% liposomal bupivacaine and normal saline or 0.25% non-liposomal bupivacaine with adrenaline. There was a significant decrease in maximal pain scores in the liposomal bupivacaine TAP group when compared with the non-liposomal bupivacaine group median (IQR [range]), 24-48 h after injection, 5 (3.0-5.2 [0-10]) vs. 6 (4.5-7.0 [1--9]) p = 0.009; 48-72 h after injection, 3 (2.0-5.0 [0-8]) vs. 5 (3.0-7.0 [0-10]) p = 0.02; and in opioid use 48-72 h after injection, mean (SD) μg equivalents of fentanyl 105 (97) vs. 182 (162) p = 0.03. Liposomal bupivacaine via subcostal TAP infiltration provided superior analgesia up to 72 h after injection when compared with non-liposomal bupivacaine.

CET Conclusion

Reviewer:	Dr Liset Pengel, Centre for Evidence in Transplantation, The Royal College of Surgeons of England.
Conclusion:	This RCT compares transversus abdominis plane (TAP) blocks using liposomal bupivacaine versus non-liposomal bupivacaine with adrenaline in patients undergoing donor nephrectomy. The study was partly blinded as staff performing the block were not blinded but patients and outcome assessors were blinded to the intervention. The sample size calculation showed that 30 patients per arm were needed to achieve a power of 80% taking into account loss to follow, conversion to open surgery or change in surgical site, or noncompliance. 59 out of 60 randomised patients were analysed and provided pain scores up to 72 hours postoperatively. The liposomal bupivacaine group had lower median maximum pain scores between 24-72 hrs postoperatively and lower opoid use between 48-72 hrs postoperatively. There was no difference in ketorolac use between groups. Nausea and vomiting were reported less frequently and the median length of hospital stay was significantly shorter for the liposomal bupivacaine group.

Reviewer:

Dr Liset Pengel, Centre for Evidence in Transplantation, The Royal College of Surgeons of England.

Conclusion:

This RCT compares transversus abdominis plane (TAP) blocks using liposomal bupivacaine versus non-liposomal bupivacaine with adrenaline in patients undergoing donor nephrectomy. The study was partly blinded as staff performing the block were not blinded but patients and outcome assessors were blinded to the intervention. The sample size calculation showed that 30 patients per arm were needed to achieve a power of 80% taking into account loss to follow, conversion to open surgery or change in surgical site, or noncompliance. 59 out of 60 randomised patients were analysed and provided pain scores up to 72 hours postoperatively. The liposomal bupivacaine group had lower median maximum pain scores between 24-72 hrs postoperatively and lower opoid use between 48-72 hrs postoperatively. There was no difference in ketorolac use between groups. Nausea and vomiting were reported less frequently and the median length of hospital stay was significantly shorter for the liposomal bupivacaine group.

Expert Review

Reviewer:	Dr Cristiano Amarelli, Monaldi, Azienda dei Colli, Naples, Italy.
Conflicts of Interest:	No
Clinical Impact Rating	4
Review:	This carefully designed trial demonstrates with a sufficient statistical power (80%), the superiority of ultrasound-guided liposomal Bupivacaine as anesthetic for transversus abdominis plane (TAP) blocks in 59 nephrectomies for kidney's living donation. Being an RCT on a surgical procedure the lack of surgical details dampened its generalizability. No data are recorded regarding clinical and/or echographic incidence of ematomas, bleedings and other surgical variables that could have led to increased pain in the control arm, then biasing the results. If an equal surgical trauma could have been demonstrated, the RCT's impact on clinical practice could have been greater thus favouring the adoption of liposomal Bupivacain as first choice drug for TAP also for similar surgical procedures. Next trials should better address surgical variables that may impact the result of an anesthetic policy over another.

Methodological quality

Jadad score	3
Allocation concealment	YES
Data analysis	MODIFIED INTENTION TO TREAT

Study Details

Aims:	To compare the effect of subcostal transversus abdominis plane (TAP) blocks using liposomal bupivacaine with TAP blocks using non-liposomal bupivacaine on postoperative maximal pain scores in patients undergoing donor nephrectomy.
Interventions:	Participants were randomized to undergo TAP block with either 1.3% liposomal bupivacaine with normal saline, versus non-liposomal 0.25% bupivacaine with adrenaline 1:200,000.
Participants:	60 donor nephrectomy patients.
Outcomes:	The primary outcome measured was maximal pain score. Other outcomes measured included opioid and ketorolac use, minimum pain scores, nausea and vomiting, and length of stay.
Follow Up:	72 hours

Metadata

Funding:	Non-industry funding
Publication type:	Comparative Study, Randomized Controlled Trial, Randomised Controlled Trial
Trial registration:	Clinicaltrials.gov - NCT02287623
Organ:	Kidney
Author email:	hutc0079@umn.edu
MeSH terms:	Abdominal Muscles; Adult; Anesthetics, Local; Bupivacaine; Female; Humans; Laparoscopy; Male; Middle Aged; Nephrectomy; Nerve Block; Pain, Postoperative; Prospective Studies; Tissue Donors; Ultrasonography, Interventional; Kidney Transplantation; 0 (Anesthetics, Local); Y8335394RO (Bupivacaine)