Comparative Evaluation of Intrathecal Administration of Levobupivacaine (Hyperbaric) Alone and Low-Dose Levobupivacaine (Hyperbaric) in Combination with Fentanyl in Lower Limb Surgeries: A Prospective Randomized Controlled Trial

Salomi A Sangma; Vishawjeet Singh; Shyamli Jamwal; Shalini Sharma; Manjula Sharma

doi:10.55489/njmr.150420251164

Authors

Salomi A Sangma Department of Anaesthesiology, SLBS Government Medical College, Ner Chowk, Mandi, Himachal Pradesh, India
Vishawjeet Singh Department of Anaesthesiology, SLBS Government Medical College, Ner Chowk, Mandi, Himachal Pradesh, India
Shyamli Jamwal Department of Anaesthesiology, SLBS Government Medical College, Ner Chowk, Mandi, Himachal Pradesh, India
Shalini Sharma Department of Anaesthesiology, SLBS Government Medical College, Ner Chowk, Mandi, Himachal Pradesh, India
Manjula Sharma Department of Anaesthesiology, SLBS Government Medical College, Ner Chowk, Mandi, Himachal Pradesh, India

DOI:

https://doi.org/10.55489/njmr.150420251164

Keywords:

Levobupivacaine, Fentanyl, Spinal Anaesthesia, Lower Limbs Surgery, Haemo-dynamic Parameters

Abstract

Background: Spinal anaesthesia is a preferred method for lower limb surgeries. Levobupivacaine, an S-enantiomer of bupivacaine, is associated with fewer cardiotoxic effects. Fentanyl, an opioid adjuvant, may enhance the efficacy of local anaesthetics. The purpose was to compare the efficacy and safety of intrathecal hyperbaric levobupivacaine alone versus low-dose levobupivacaine with fentanyl in lower limb surgeries.

Methodology: Eighty ASA I-II patients undergoing elective lower limb surgeries were randomly divided into two groups. Group L received 15 mg hyperbaric levobupivacaine; Group LF received 12.5 mg levobupivacaine with 25 µg fentanyl intrathecally. Sensory/motor block characteristics, haemodynamic stability, and side effects were assessed.

Results: The onset of sensory block was faster in Group L (2.86 ± 0.97 min) than Group LF (3.42 ± 0.96 min) (p = 0.011). Sensory block lasted slightly longer in Group LF (102.37 ± 17.72 min vs. 96.88 ± 27.85 min; p = 0.305). Motor block durations were comparable (p = 0.952). Haemodynamic parameters remained stable and similar between groups. Side effects, including hypotension and bradycardia, were slightly more frequent in Group L, but not statistically significant.

Conclusion: Both regimens are effective and safe. Levobupivacaine alone provides faster onset, while the addition of fentanyl permits dose reduction without compromising efficacy. The combination is a clinically useful alternative for lower limb surgeries with minimal side effects.

References

Wang C, Chakrabarti MK, Whitwam JG. Specific enhancement by fentanyl of the effects of intrathecal bupivacaine on nociceptive afferent but not on sympathetic efferent pathways in dogs. Anesthesiology. 1993;79(4):766-773. DOI: https://doi.org/10.1097/00000542-199310000-00019 PMid:8214756 DOI: https://doi.org/10.1097/00000542-199310000-00019

Neal JM. Hypotension and bradycardia during spinal anesthesia: significance, prevention, and treatment. Tech Reg Anesth Pain Manag. 2000;4(4):148-154. DOI: https://doi.org/10.1053/trap.2000.20600 DOI: https://doi.org/10.1053/trap.2000.20600

Choi WS, Samman N. Risks and benefits of deliberate hypotension in anaesthesia: a systematic review. Int J Oral Maxillofac Surg. 2008;37(8):687-703. DOI: https://doi.org/10.1016/j.ijom.2008.03.011 PMid:18511238 DOI: https://doi.org/10.1016/j.ijom.2008.03.011

Cheung CC, Martyn A, Campbell N, et al. Predictors of intraoperative hypotension and bradycardia. Am J Med. 2015;128(5):532-538. DOI: https://doi.org/10.1016/j.amjmed.2014.11.030 PMid:25541033 DOI: https://doi.org/10.1016/j.amjmed.2014.11.030

Salinas F V, Sueda LA, Liu SS. Physiology of spinal anaesthesia and practical suggestions for successful spinal anaesthesia. Best Pract Res Clin Anaesthesiol. 2003;17(3):289-303. DOI: https://doi.org/10.1016/S1521-6896(02)00114-3 PMid:14529003 DOI: https://doi.org/10.1016/S1521-6896(02)00114-3

Attri J, Kaur G, Kaur S, Kaur R, Mohan B, Kashyap K. Comparison of levobupivacaine and levobupivacaine with fentanyl in infraumbilical surgeries under spinal anaesthesia. Anesth Essays Res. 2015;9(2):178-184. DOI: https://doi.org/10.4103/0259-1162.152148 PMid:26417124 PMCid:PMC4563977 DOI: https://doi.org/10.4103/0259-1162.152148

Sawhney KY, Kundra S, Grewal A, Katyal S, Singh G, Kaur A. A Randomized Double Blinded Comparison of Epidural Infusion of Bupivacaine, Ropivacaine, Bupivacaine-Fentanyl, Ropivacaine-Fentanyl for Postoperative Pain Relief in Lower Limb Surgeries. J Clin Diagn Res. 2015 Sep;9(9):UC19-23. DOI: https://doi.org/10.7860/JCDR/2015/15157.6459 PMid:26500984 PMCid:PMC4606313 DOI: https://doi.org/10.7860/JCDR/2015/15157.6459

Bajwa SJS, Arora V, Kaur J, Singh A, Parmar SS. Comparative evaluation of dexmedetomidine and fentanyl for epidural analgesia in lower limb orthopedic surgeries. Saudi J Anaesth. 2011;5(4):365-370. DOI: https://doi.org/10.4103/1658-354X.87264 PMid:22144922 PMCid:PMC3227304 DOI: https://doi.org/10.4103/1658-354X.87264

Naik D, Koppal R, Mathpati V, Hulkund S. A comparative study of intrathecal 0.5% isobaric levobupivacaine with fentanyl and 0.5% isobaric levobupivacaine with nalbuphine in infraumbilical surgeries: A randomized double blind clinical trial. Indian J Clin Anaesth. 2019;6(2):203-208. DOI: https://doi.org/10.18231/j.ijca.2019.038 DOI: https://doi.org/10.18231/j.ijca.2019.038

Jagtap S, Chhabra A, Dawoodi S, Jain A. Comparison of intrathecal ropivacaine-fentanyl and bupivacaine-fentanyl for major lower limb orthopaedic surgery: A randomised double-blind study. Indian J Anaesth. 2014;58(4):442-446. DOI: https://doi.org/10.4103/0019-5049.138985 PMid:25197113 PMCid:PMC4155290 DOI: https://doi.org/10.4103/0019-5049.138985

Choi DH, Ahn HJ, Kim MH. Bupivacaine-sparing effect of fentanyl in spinal anesthesia for cesarean delivery. Reg Anesth Pain Med. 2000 May-Jun;25(3):240-5. doi: 10.1016/s1098-7339(00)90005-1. PMID: 10834777. DOI: https://doi.org/10.1097/00115550-200005000-00006

Jørgensen H, Wetterslev J, Møiniche S, Dahl JB. Epidural local anaesthetics versus opioid-based analgesic regimens on postoperative gastrointestinal paralysis, PONV and pain after abdominal surgery. Cochrane Database Syst Rev. 2000;(4):CD001893. DOI: https://doi.org/10.1002/14651858.CD001893. Update in: Cochrane Database Syst Rev. 2016 Jul 16;7:CD001893. DOI: https://doi.org/10.1002/14651858.CD001893.pub2. PMID: 11034732. DOI: https://doi.org/10.1002/14651858.CD001893.pub2

Uike DS, Choudhary DS, Jain DA. Comparative study of analgesic effect of intrathecal bupivacaine and bupivacaine with fentanyl during and after cesarean delivery. Int J Med Res Rev. 2015;3(3):256-262. DOI: https://doi.org/10.17511/ijmrr.2015.i3.045 DOI: https://doi.org/10.17511/ijmrr.2015.i3.045

Singh V, Gupta LK, Singh GP. Comparison among intrathecal fentanyl and butorphanol in combination with bupivacaine for lower limb surgeries. J Anaesthesiol Clin Pharmacol. 2006;22(4):371-375.

Chanchayanon T, Chearong M, Vasinanukorn P, Withayanuphakorn N, Sangkaew T. Incidence of hypotension between intrathecal hyperbaric bupivacaine with and without fentanyl in geriatric patients undergoing urological surgeries. J Heal Sci Med Res. 2019;37(2):93-99. DOI: https://doi.org/10.31584/jhsmr.201944 DOI: https://doi.org/10.31584/jhsmr.201944

Khosravi F, Sharifi M, Jarineshin H. Comparative study of fentanyl vs dexmedetomidine as adjuvants to intrathecal bupivacaine in cesarean section: A randomized, double-blind clinical trial. J Pain Res. 2020;Volume 13:2475-2482. DOI: https://doi.org/10.2147/JPR.S265161 PMid:33116789 PMCid:PMC7548853 DOI: https://doi.org/10.2147/JPR.S265161

Shah VR, Mehta S, Khan DA. Comparative study of intrathecal fentanyl with bupivacaine and fentanyl midazolam with bupivacaine in spinal anaesthesia. Indian J Clin Anaesth. 2021;8(2):302-309. DOI: https://doi.org/10.18231/j.ijca.2021.056 DOI: https://doi.org/10.18231/j.ijca.2021.056

Malawat A, Sachdeva S, M Parekh K, Jethava D, Mansuri T. Comparison of intrathecal dexmedetomidine and intrathecal fentanyl as an adjuvant with hyperbaric bupivacaine for spinal anaesthesia in lower limb surgeries: A prospective randomized clinical trial. Indian J Clin Anaesth. 2020;7(2):226-232. DOI: https://doi.org/10.18231/j.ijca.2020.041 DOI: https://doi.org/10.18231/j.ijca.2020.041

Routray SS, Ravi K, Mishra D. Effect of intrathecal dexmedetomidine and fentanyl as adjuvant to hyperbaric bupivacaine for orthopaedic lower limb and lower abdominal procedures: A double blind control Study. Indian J Clin Anaesth. 2015;2(4):204-208. DOI: https://doi.org/10.5958/2394-4994.2015.00030.X DOI: https://doi.org/10.5958/2394-4994.2015.00030.X

Ben-David B, Solomon E, Levin H, Admoni H, Goldik Z. Intrathecal fentanyl with small-dose dilute bupivacaine. Anesth Analg. 1997;85(3):560-565. DOI: https://doi.org/10.1097/00000539-199709000-00014 PMid:9296409 DOI: https://doi.org/10.1097/00000539-199709000-00014

De Santiago J, Santos-Yglesias J, Giron J, Jimenez A, Errando CL. Low-dose, low-concentration levobupivacaine plus fentanyl selective spinal anesthesia for knee arthroscopy: a dose finding study. Anesth Analg. 2011;112(2):477-480. DOI: https://doi.org/10.1213/ANE.0b013e318202cd03 PMid:21127284 DOI: https://doi.org/10.1213/ANE.0b013e318202cd03

Gupta M, Pratap R, Singh GP. Efficacy and duration of analgesia with levobupivacaine combined with fentanyl or dexmedetomidine in lower extremity surgery: A meta-analysis. Asian J Med Sci. 2025;16(3):15-23. DOI: https://doi.org/10.71152/ajms.v16i3.4352 DOI: https://doi.org/10.71152/ajms.v16i3.4352

Honca M, Dereli N, Kose EA, et al. Low-dose levobupivacaine plus fentanyl combination for spinal anesthesia in anorectal surgery. Brazilian J Anesthesiol (English Ed. 2015;65(6):461-465. DOI: https://doi.org/10.1016/j.bjane.2014.01.007 PMid:26614142 DOI: https://doi.org/10.1016/j.bjane.2014.01.007

Akan B, Yagan O, Bilal B, Erdem D, Gogus N. Comparison of levobupivacaine alone and in combination with fentanyl and sufentanil in patients undergoing transurethral resection of the prostate. J Res Med Sci. 2013;18(5):378-382. http://www.ncbi.nlm.nih.gov/pubmed/24174940.

Goyal A, Shankaranarayan P, Ganapathi P. A randomized clinical study comparing spinal anesthesia with isobaric levobupivacaine with fentanyl and hyperbaric bupivacaine with fentanyl in elective cesarean sections. Anesth Essays Res. 2015;9(1):57-62. DOI: https://doi.org/10.4103/0259-1162.150169 PMid:25886422 PMCid:PMC4383120 DOI: https://doi.org/10.4103/0259-1162.150169

Gupta P, Chouhan RS, Jangir KG, Rathore VS, Audichya PC, Goyal S. A Comparison of Intrathecal Dexmedetomidine and Fentanyl as Adjuvants to 0.5% Hyperbaric Levobupivacaine for Lower Abdominal Surgeries: A Prospective, Double-Blinded, Randomized Controlled Trial. Cureus. 2024 Dec 23;16(12):e76292. DOI: https://doi.org/10.7759/cureus.76292. PMID: 39850166; PMCID: PMC11754921. DOI: https://doi.org/10.7759/cureus.76292

Raghavi.R, Balamurugan B, Saravanakumar.R VJ. Comparative study of intrathecal isobaric levobupivacaine (0.5%) 3ml with dexmedetomidine 0.5ml (5 mcg) and isobaric levobupivacaine (0.5%) 3ml with fentanyl 0.5ml (25 mcg) in patients undergoing surgeries under subarachnoid block: a prospective randomize. J Chem Heal Risks. 2024;14(2):1656-1666.

Sabertanha A, Makhmalbaf GR, Bayati M, Meshkini A. The Effect of Intrathecal Bupivacaine Plus Dextrose 5% and Fentanyl Compared with Bupivacaine Alone on the Onset and Duration of Analgesia in Patients Undergoing Lower-Limb Orthopedic Surgery. Adv Orthop. 2023 Feb 14;2023:2496557. DOI: https://doi.org/10.1155/2023/2496557 PMid:36824661 PMCid:PMC9943617 DOI: https://doi.org/10.1155/2023/2496557