Safety and effectiveness of adding fentanyl or sufentanil to spinal anesthesia: systematic review and meta-analysis of randomized controlled trials

Fonseca, Neuber Martins; Guimarães, Gabriel Magalhães Nunes; Pontes, João Paulo Jordão; Azi, Liana Maria Tores de Araujo; de Ávila Oliveira, Ricardo

doi:10.1016/j.bjane.2021.10.010

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Brazilian Journal of Anesthesiology

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Sumário

Systematic Review • para Braz. J. Anesthesiol. 73 (2) • Mar-Apr 2023 • https://doi.org/10.1016/j.bjane.2021.10.010 copy

Safety and effectiveness of adding fentanyl or sufentanil to spinal anesthesia: systematic review and meta-analysis of randomized controlled trials

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Introduction

Spinal infusions of either fentanyl or sufentanil have been reported in international reports, articles, and scientific events worldwide. This study aimed to determine whether intrathecal fentanyl or sufentanil offers safety in mortality and perioperative adverse events.

Methods

MEDLINE (via PubMed), EMBASE, CENTRAL (Cochrane library databases), gray literature, hand-searching, and clinicaltrials.gov were systematically searched. Randomized controlled trials with no language, data, or status restrictions were included, comparing the effectiveness and safety of adding spinal lipophilic opioid to local anesthetics (LAs). Data were pooled using the random-effects models or fixed-effect models based on heterogeneity.

Results

The initial search retrieved 4469 records; 3241 records were eligible, and 3152 articles were excluded after reading titles and abstracts, with a high agreement rate (98.6%). After reading the full texts, 76 articles remained. Spinal fentanyl and sufentanil significantly reduced postoperative pain and opioid consumption, increased analgesia and pruritus. Fentanyl, but not sufentanil, significantly reduced both postoperative nausea and vomiting, and postoperative shivering; compared to LAs alone. The analyzed studies did not report any case of in-hospital mortality related to spinal lipophilic opioids. The rate of respiratory depression was 0.7% and 0.8% when spinal fentanyl or sufentanil was added and when it was not, respectively. Episodes of respiratory depression were rare, uneventful, occurred intraoperatively, and were easily manageable.

Conclusion

There is moderate to high quality certainty that there is evidence regarding the safety and effectiveness of adding lipophilic opioids to LAs in spinal anesthesia.

KEYWORDS
Anesthesia, spinal; Fentanyl; Sufentanil; Safety; Drug-related side effects and adverse reactions

	Study	Surgery	Patient gender		Country	Number of patients		Control		Experiment		Opioid	Dose (µg)
	Study	Surgery	Male	Female	Country	Control	Experiment	LA	Dose (mg)	LA	Dose (mg)	Opioid	Dose (µg)
01	Abdollahpour et al. 2015	Cesarean section	0	50	Iran	25	25	Bupivacaine 0.5%	12,5	Bupivacaine 0.5%	12,5	Sufentanil	1.5
02	Acharya et al. 2019	Cesarean section	0	60	Nepal	30	30	Bupivacaine 0.5%	10	Bupivacaine 0.5%	10	Fentanyl	12.5
03	Agrawal et al. 2016	Cesarean section	0	40	India	20	20	Bupivacaine 0.5%	12.5	Bupivacaine 0.5%	12.5	Fentanyl	25
04	Akan et al. 2013	TURP	60	0	Turkey	20	20/20	Levobupivacaine 0.5%	10	Levobupivacaine 0.5%	7.5/7.5	Fentanyl/Sufentanil	25/2.5
05	Asokumar et al. 1998	Labor analgesia	0	41	United States of America	19	22	Bupivacaine 0.25%	2.5	Bupivacaine 0.25%	2.5	Fentanyl	25
06	Atallah et al. 2003	Transurethral Cystoscopic Surgery	NS	NS	Egypt	40	40	Bupivacaine 0.1%	5	Bupivacaine 0.1%	5	Fentanyl	20
07	Atallah et al. 2006	Percutaneous nephrolitotomy	64	41	Egypt	54 (ITT)	54 (ITT)	Bupivacaine 0.5%	7.5	Bupivacaine 0.5%	7.5	Fentanyl	10
08	Attri et al. 2015	Infraumbilical surgeries	83	17	India	50	50	Levobupivacaine 0.5%	10	Levobupivacaine 0.5%	10	Fentanyl	25
09	Aydın et al. 2011	Arthroscopic knee surgery	25	25	Turkey	25	25	Bupivacaine 0.5%	10	Bupivacaine 0.5%	5	Sufentanil	2.5
10	Bang et al. 2012	Cesarean section	0	105	South Korea	35	35/35	Bupivacaine 0.5%	6.5-11	Bupivacaine 0.5%	6.5-11	Sufentanil	2.5/5
11	Ben-David et al. 1997	Arthroscopic knee surgery	40	10	Israel	25	25	Bupivacaine 0.5%	5	Bupivacaine 0.5%	5	Fentanyl	10
12	Ben-David et al. 2000	Surgery repair of hip fracture	2	18	Israel	10	10	Bupivacaine 0.5%	10	Bupivacaine 0.5%	4	Fentanyl	20
13	Bidikar et al. 2017	Cesarean section	0	60	India	30	30	Levoupivacaine 0.5%	10	Levoupivacaine 0.5%	7.5	Fentanyl	12.5
14	Biswas et al. 2002	Cesarean section	0	40	India	20	20	Bupivacaine 0.5%	10	Bupivacaine 0.5%	10	Fentanyl	12.5
15	Braga et al. 2003	Cesarean section	0	80	Brazil	20	20/20/20	Bupivacaine 0.5%	12.5	Bupivacaine 0.5%	12.5	Sufentanil	2.5/5/7.5
16	Braga et al. 2012	Cesarean section	0	48	Brazil	24	24	Bupivacaine 0.5%	10	Bupivacaine 0.5%	10	Sufentanil	5
17	Chandra et al. 2008	Cesarean section	0	60	India	20	20/20	Bupivacaine 0.5%	7.5	Bupivacaine 0.5%	7.5	Fentanyl/Sufentanil	25/5
18	Chilvers et al. 1997	Gynecological laparoscopy	0	63	Canada	21	21/21	Lidocaine 1%	20	Lidocaine 1%	20	Fentanyl	10/25
19	Cowan et al. 2002	Cesarean section	0	50	United Kingdom	25	25	Bupivacaine 0.5%	13.75	Bupivacaine 0.5%	13.75	Fentanyl	20
20	Dahlgren et al. 1997	Cesarean section	0	80	Sweden	20	20/20/20	Bupivacaine 0.5%	12.5	Bupivacaine 0.5%	12.5	Fentanyl/Sufentanyl	F10/S2.5/S5
21	Demiraran et al. 2006	Cesarean section	0	100	Turkey	25	25/25/25	Bupivacaine 0.5%	12.5	Bupivacaine 0.5%	12.5	Sufentanil	1.5/2.5/5
22	Derakhshan et al. 2018	Lower limb surgery	32	28	Iran	30	30	Bupivacaine 0.5%	15	Bupivacaine 0.5%	15	Sufentanil	5
23	Desai et al. 2019	Femur surgery	39	21	India	30	30	Bupivacaine 0.5%	12.5	Bupivacaine 0.5%	7.5	Fentanyl	25
24	Doger et al. 2014	TURP	20	0	Nigeria	20	20	Bupivacaine 0.5%	10	Bupivacaine 0.5%	7.5	Sufentanil	5
25	Donadoni et al. 1987	Urological procedures	35	3	Belgium	20 (ITT)	20 (ITT)	Lidocaine 5%	75	Lidocaine 5%	75	Sufentanil	5
26	Farzi et al. 2017	Cesarean Section	0	92	Iran	33 (ITT)	33 (ITT)/33(ITT)	Bupivacaine 0.5%	12.5	Bupivacaine 0.5%	12.5	Fentanyl/Sufentanil	25/2.5
27	Gauchan et al. 2014	Cesarean Section	0	70	Nepal	35	35	Bupivacaine 0.5%	12	Bupivacaine 0.5%	10	Fentanyl	20
28	Girgin et al. 2008	Inguinal herniorrhaphy	31	7	Turkey	20 (ITT)	20 (ITT)	Levoupivacaine 0.5%	7.5	Levoupivacaine 0.5%	5	Fentanyl	25
29	Gupta et al. 2013	Urological procedures	66	24	India	30	30/30	Bupivacaine 0.5%	7.5	Bupivacaine 0.5%	7.5	Fentanyl/Sufentanil	25/10
30	Gurbet et al. 2008	Anorrectal surgery	24	11	Turkey	20 (ITT)	20 (ITT)	Bupivacaine 0.5%	5	Bupivacaine 0.5%	2.5	Fentanyl	25
31	Hakkim et al. 2015	Lower abdomen, urological, and lower extremities	55	45	India	50	50	Bupivacaine 0.5%	12.5	Bupivacaine 0.5%	12.5	Sufentanil	5
32	Hassani et al. 2014	Lower Extremity Surgery	67	23	Iran	30	30/30	Bupivacaine 0.5%	15	Bupivacaine 0.5%	15	Fentanyl/Sufentanil	25/2.5
33	Hoda et al. 2007	Hip fracture surgery	NS	NS	Pakistain	30	30/30	Bupivacaine 0.5%	10	Bupivacaine 0.5%	8/6	Fentanyl	20/20
34	Hunt et al. 1989	Cesarean section	0	55	United States of America	9	6/8/7/7/6/7/5	Bupivacaine 0.5%	7.5-11	Bupivacaine 0.5%	7.5-11	Fentanyl	2.5/5/6.25/12.5/25/37.5/50
35	Jain et al. 2004	Cesarean section	0	45	India	15	15/15	Bupivacaine 0.5%	7.5	Bupivacaine 0.5%	7.5	Fentanyl	10/20
36	Kararmaz et al. 2003	TURP	40	0	Turkey	20	20	Bupivacaine 0.5%	7.5	Bupivacaine 0.5%	4	Fentanyl	25
37	Kaur et al. 2011	Urological procedures	55	5	India	30	30	Bupivacaine 0.5%	12.5	Bupivacaine 0.5%	7.5	Sufentanil	10
38	Kezri et al. 2014	Cesarean section	0	60	Iran	30	30	Bupivacaine 0.5%	10	Bupivacaine 0.5%	10	Fentanyl	25
39	Korhonen et al. 2003	Knee arthroscopy	47	51	Finland	50 (ITT)	50 (ITT)	Bupivacaine 0.5%	4	Bupivacaine 0.5%	3	Fentanyl	10
40	Kuberan et al. 2018	Cesarean section	0	36	India	18 (ITT)	18 (ITT)	Bupivacaine 0.5%	2,5	Bupivacaine 0.5%	2	Fentanyl	15
41	Kuusniemi et al. 2000	Urological procedures	35	45	Finland	20	20/20/20	Bupivacaine 0.5%	10	Bupivacaine 0.5%	10/7.5/7.5	Fentanyl	25/25/25
42	Lauretti et al. 1998	Abdominal hysterectomy	0	50	Brazil	10	10/10/10	Bupivacaine 0.5%	15	Bupivacaine 0.5%	15	Fentanyl	25/10/25
43	Lee et al. 2005	Urological procedures	NS	NS	Hong Kong	25	25	Levobupivacaine 0.5%	13	Levobupivacaine 0.5%	11.5	Fentanyl	15
44	Lee et al. 2009	Lower extremity surgery	19	16	Korea	20/20	20	Bupivacaine 0.5%	10/5	Bupivacaine 0.5%	5	Fentanyl	10
45	Lee et al. 2011	Cesarean section	0	72	Korea	24	24/24	Bupivacaine 0.5%	6.5-12	Bupivacaine 0.5%	6.5-12	Fentanyl/Sufentanil	20/2.5
46	Mahajan et al. 2005	Cesarean section	0	24	India	12	12	Bupivacaine 0.5%	7.5	Bupivacaine 0.5%	7.5	Fentanyl	20
47	Makwana et al. 2014	Abdominal hysterectomy	0	60	India	30	30	Bupivacaine 0.5%	15	Bupivacaine 0.5%	15	Fentanyl	25
48	Martin et al. 1999	Oocyte retrieval procedures	0	78	EUA	40	38	Lidocaine 1,5%	45	Lidocaine 1,5%	45	Fentanyl	10
49	Martyr et al. 2001	Hip fractures	9	33	Australia	25 (ITT)	23 (ITT)	Bupivacaine 0.5%	12.5	Bupivacaine 0.5%	7.5	Fentanyl	20
50	Neeta et al. 2015	Urologic, Gynecologic, Orthopedics and general surgery	NS	NS	India	20	20/20	Bupivacaine 0.5%	15	Bupivacaine 0.5%	15	Fentanyl/Sufentanil	25/5
51	Ngiam et al. 1998	Cesarean section	0	60	Singapore	20 (ITT)	20/20 (ITT)	Bupivacaine 0.5%	7.5	Bupivacaine 0.5%	7.5	Fentanyl/Sufentanil	15/10
52	Olofsson et al. 2004	Hip fractures	NS	NS	Sweden	25	25	Bupivacaine 0.5%	15	Bupivacaine 0.5%	7.5	Sufentanil	5
53	Ozyilkan et al. 2013	Cesarean section	0	93	Turkey	31	31/31	Levobupivacaine 0.5%	2.2 ± 0.2 mL	Levobupivacaine 0.5%	2.2 ± 0.2 mL	Fentanyl/Sufentanil	10/2,5
54	Palmer et al. 1995	Cesarean section	0	28	EUA	14	14	Hyperbaric lidocaine 1,5%	80	Hyperbaric lidocaine 1,5%	80	Fentanyl	15
55	Rajbhandari et al. 2020	Emergency appendectomy	52	68	Nepal	30	30/30/30	Bupivacaine 0.5%	15	Bupivacaine 0.5%	15/15/15	Fentanyl	10/20/30
56	Randalls et al. 1991	Cesarean section	0	48	UK	12	12/12/12	Bupivacaine 0.5%	12.5	Bupivacaine 0.5%	12.5	Fentanyl	10
57	Sadegh et al. 2012	Cesarean section	0	80	Iran	40	40	Bupivacaine 0.5%	12.5	Bupivacaine 0.5%	12.5	Fentanyl	25
58	Seewal et al. 2007	Inguinal hernia repair	60	0	UK	12	12/12/12/12	Bupivacaine 0.5%	11	Bupivacaine 0.5%	11/11/11/11	Fentanyl	10/20/30/50
59	Sertoz et al. 2014	Knee arthroscopy	33	26	Turkey	33 (ITT)	29	Bupivacaine 0.5%	5	Bupivacaine 0.5%	5	Sufentanil	2,5
60	Seyhan et al. 2006	Cesarean section	0	45	Turkey	15	15/15	Bupivacaine 0.5%	9	Bupivacaine 0.5%	9	Fentanyl	10/20
61	Shahriari et al. 2007	Cesarean section	0	40	Iran	20	20	Lidocaine 5%	80	Lidocaine 5%	80	Fentanyl	15
62	Shende et al. 1998	Cesarean section	0	40	UK	20	20	Bupivacaine 0.5%	12.5	Bupivacaine 0.5%	12.5	Fentanyl	15
63	Shim et al. 2018	Anorectasl surgery	35	45	Korea	40	40	Bupivacaine 0.5%	5	Bupivacaine 0.5%	5	Fentanyl	15
64	Singh et al. 1995	Genitourinary surgery	43	0	USA	22	21	Bupivacaine 0.5%	13.5	Bupivacaine 0.5%	13.5	Fentanyl	25
65	Sung et al. 2013	Inguinal hernia repair	68	4	Korea	38 (ITT)	36	Bupivacaine 0.5%	14	Bupivacaine 0.5%	13	Fentanyl	10
66	Techanivate et al. 2004	Appendectomy	NS	NS	Thailand	20	20	Bupivacaine 0.5%	20	Bupivacaine 0.5%	20	Fentanyl	20
67	Tyagi et al. 2013	Cesarean section	0	90	India	30	30/30	Bupivacaine 0.5%	10	Bupivacaine 0.5%	10/10	Fentanyl	12,5/25
68	Unal et al. 2012	Knee arthroscopy	18	25	Turkey	15	15 (ITT)/15 (ITT)	Bupivacaine 0.5%	4	Bupivacaine 0.5%	4/3	Fentanyl	25/25
69	Venkata et al. 2015	Cesarean section	0	50	India	25	25	Bupivacaine 0.5%	10	Bupivacaine 0.5%	7,5	Fentanyl	25
70	Vyas et al. 2010	Cesarean section	0	60	India	30	30	Bupivacaine 0.5%	11	Bupivacaine 0.5%	11	Sufentanil	5
71	Wang et al. 2019	Total Hip Arthroplasty	55	5	China	33 (ITT)	32 (ITT)	Bupivacaine 0.5%	10	Bupivacaine 0.5%	7,5	Fentanyl	20
72	Walsh et al. 2003	TURP	30	0	Ireland	15 (ITT)	15 (ITT)	Bupivacaine 0.5%	15	Bupivacaine 0.5%	10	Fentanyl	25
73	Waxler et al. 2004	Rectal ambulatory surgery	37	12	USA	21	28	Hyperbaric lidocaine 1,5%	15	Hyperbaric lidocaine 5%	50	Sufentanil	10
74	Weigl et al. 2016	Cesarean section	0	59	Poland	30 (ITT)	30 (ITT)	Bupivacaine 0.5%	7.5-15	Bupivacaine 0.5%	7.5-15	Fentanyl	25
75	Yi-chun et al. 2006	TURP	90	0	China	30	30/30	Bupivacaine 0.5%	15	Bupivacaine 0.5%	7.5/7.5	Sufentanil	5/7,5
76	Zohar et al. 2007	Transurethral procedures	100	0	Israel	25	25/25/25	Bupivacaine 0.5%	7.5	Bupivacaine 0.5%	5/4/3	Fentanyl	20/20/20

Sociedade Brasileira de Anestesiologia (SBA) Rua Professor Alfredo Gomes, 36, Botafogo , cep: 22251-080 - Rio de Janeiro - RJ / Brasil , tel: +55 (21) 97977-0024 - Rio de Janeiro - RJ - Brazil
E-mail: editor.bjan@sbahq.org

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[1] ⁎ Corresponding author. E-mail:neubermf@gmail.com (N.M. Fonseca).