Analgesia Clinical Trial
— PENGITOfficial title:
Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty: a Double Blind, Non-inferiority Study
The aim of this clinical trial is to compare the analgesic effect of pericapsular nerve block (PENG) with intrathecal morphine in patients scheduled for total hip replacement surgery. The main question to be answered is whether the PENG block is equivalent to intrathecal morphine in reducing postoperative pain. Participants will be randomised into two groups. Patients assigned to the PENG group will receive spinal anaesthesia with local anaesthetic (isobaric bupivacaine) alone and a PENG block. Patients assigned to the intrathecal morphine (ITM) group will receive spinal anaesthesia with a mixture of local anaesthetic (isobaric bupivacaine) and morphine (100 mcg) and a sham PENG block to ensure patient blinding.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | May 1, 2027 |
Est. primary completion date | January 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male and female patients - ASA (American Society of Anaesthesiologists) I-III - 18 years of age or older - Patients scheduled for elective primary hip arthroplasty - Able to give written conformed consent autonomously Exclusion Criteria: - Refusal or inability to give consent - Allergy to any of: ropivacaine, paracetamol, ibuprofen, ketorolac, morphine, ondansetron or dexamethasone - Bleeding diathesis - Neurological deficit of the operative side - Existing preoperative opioid use - Renal insufficiency (GFR<30ml/min according to the Cockroft-Gault formula) - Hepatic insufficiency - Pregnant or lactating women |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital of Lausanne | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Vaudois |
Switzerland,
Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20. — View Citation
Anger M, Valovska T, Beloeil H, Lirk P, Joshi GP, Van de Velde M, Raeder J; PROSPECT Working Group* and the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guideline for total hip arthroplasty: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Aug;76(8):1082-1097. doi: 10.1111/anae.15498. Epub 2021 May 20. — View Citation
Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847. — View Citation
Gonvers E, El-Boghdadly K, Grape S, Albrecht E. Efficacy and safety of intrathecal morphine for analgesia after lower joint arthroplasty: a systematic review and meta-analysis with meta-regression and trial sequential analysis. Anaesthesia. 2021 Dec;76(12):1648-1658. doi: 10.1111/anae.15569. Epub 2021 Aug 27. — View Citation
Hu J, Wang Q, Hu J, Kang P, Yang J. Efficacy of Ultrasound-Guided Pericapsular Nerve Group (PENG) Block Combined With Local Infiltration Analgesia on Postoperative Pain After Total Hip Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2023 Jun;38(6):1096-1103. doi: 10.1016/j.arth.2022.12.023. Epub 2022 Dec 16. — View Citation
Kearns R, Macfarlane A, Grant A, Puxty K, Harrison P, Shaw M, Anderson K, Kinsella J. A randomised, controlled, double blind, non-inferiority trial of ultrasound-guided fascia iliaca block vs. spinal morphine for analgesia after primary hip arthroplasty. Anaesthesia. 2016 Dec;71(12):1431-1440. doi: 10.1111/anae.13620. Epub 2016 Oct 7. — View Citation
Kuchalik J, Granath B, Ljunggren A, Magnuson A, Lundin A, Gupta A. Postoperative pain relief after total hip arthroplasty: a randomized, double-blind comparison between intrathecal morphine and local infiltration analgesia. Br J Anaesth. 2013 Nov;111(5):793-9. doi: 10.1093/bja/aet248. Epub 2013 Jul 19. — View Citation
Lin DY, Brown B, Morrison C, Fraser NS, Chooi CSL, Cehic MG, McLeod DH, Henningsen MD, Sladojevic N, Kroon HM, Jaarsma RL. The Pericapsular Nerve Group (PENG) block combined with Local Infiltration Analgesia (LIA) compared to placebo and LIA in hip arthroplasty surgery: a multi-center double-blinded randomized-controlled trial. BMC Anesthesiol. 2022 Aug 6;22(1):252. doi: 10.1186/s12871-022-01787-2. — View Citation
Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1. — View Citation
Roofthooft E, Joshi GP, Rawal N, Van de Velde M; PROSPECT Working Group* of the European Society of Regional Anaesthesia and Pain Therapy and supported by the Obstetric Anaesthetists' Association. PROSPECT guideline for elective caesarean section: updated systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 May;76(5):665-680. doi: 10.1111/anae.15339. Epub 2020 Dec 28. — View Citation
Souron V, Delaunay L, Schifrine P. Intrathecal morphine provides better postoperative analgesia than psoas compartment block after primary hip arthroplasty. Can J Anaesth. 2003 Jun-Jul;50(6):574-9. doi: 10.1007/BF03018643. — View Citation
Vitola E, Buraka N, Erts R, Golubovska I, Miscuks A. Effect of different low doses of intrathecal morphine (0.1 and 0.2 mg) on pain and vital functions in patients undergoing total hip arthroplasty: a randomised controlled study. BMC Anesthesiol. 2022 Dec 5;22(1):377. doi: 10.1186/s12871-022-01919-8. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative postoperative morphine consumption at day 1 | total consumption in mg | 24 hours postoperatively | |
Secondary | Morphine consumption in the recovery room | consumption in mg | from admission till discharge from the recovery room, up to 2 hours | |
Secondary | PCA administered morphine consumption at day 2 | consumption in mg administered by PCA | at day 2 postoperatively | |
Secondary | rest and dynamic pain scores | Visual Analogue Scale(VAS), 0-10 | at 2 hours, day 1 and day 2 postoperatively | |
Secondary | Incidence of postoperative nausea and vomiting | Presence of nausea or vomiting in the postoperative period | at 2 hours, day 1 and day 2 postoperatively | |
Secondary | Incidence of pruritus | Presence of pruritus in the postoperative period | at 2 hours, day 1 and day 2 postoperatively | |
Secondary | Incidence of urinary retention requiring bladder catheterisation | Urinary retention requiring catheterisation | from surgery till day 2 postoperatively | |
Secondary | Duration of analgesia | Time between study procedure and the first dose of iv morphine | from the time the study procedure is performed up to 36 hours after surgery | |
Secondary | operated limb quadriceps strength | Medical Research Council Manual Muscle Testing scale, 0-5 | at day 1 and day 2 postoperatively | |
Secondary | Walking test | maximum distance travelled (meters) | at day 1 and 2 postoperatively |
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