Effects of Calot's Triangle Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy: a Prospective, Randomized, Double-blind, Controlled, Clinical Trial
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Laparoscopic cholecystectomy (LC) is currently regarded as the gold standard treatment for symptomatic gallstone disease. Compared with open cholecystectomy, LC benefits include less postoperative pain, reduced analgesic consumption, and earlier discharge. However, besides the advantages mentioned above, there are exist complexity and diversity of the acute pain after LC, which consists of a somatic, a visceral and a referred pain component. Meanwhile, our team also found many LC patients experience visceral pain after surgery. According to epidemic research show that chronic pain after LC is a common complication with an incidence ranging between 3-56%. Several reports have indicated that early postoperative pain has been shown to be a significant risk factor of chronic pain. In many cases, however, the cause chronic pain after LC remains unknown and visceral hyperalgesia and central sensitizationhave been suggested to be part of the pathophysiology. To reduce the incidence of chronic pain after LC, so we conduct the randomized controlled trial to investigate whether calot's triangle block combined with PCIA is superior to PCIA in reducing the incidence of chronic pain after LC.
This study was approved by the institutional review board of the First Affiliated Hospital of Chongqing Medical University. The protocol design is in accordance with Consolidated Standards of Reporting Trials (CONSORT) statement. All potentially eligible participants will be asked to give written informed consent before they are enrolled in this study. This study is a prospective, randomized, double-blind, controlled clinical trial guided by the standard of good clinical practice (GCP), and eligible participants are divided into two groups: group CTB and group PCIA, and primary assess the outcomes of the incidence of chronic pain after LC and the intensity of acute pain after LC.
Participants in group CTB will receive a single injection of ropivacaine in calot's triangle before surgical dissection combined with PCIA post-operatively.
Participants in group PCIA will receive a single injection in calot's triangle with normal saline before surgical dissection and PCIA post-operatively.
The primary outcome of this study is the incidence of chronic pain after LC.
The secondary outcomes of this study are acute post-operative pain, moderate-severe pain, rescue medication and adverse events associated with the post-operative analgesia.
This study will be conducted under the supervision of an independent auditor. Every week, the auditor checked the data of the participants the day after the surgery was conducted. Assessment of pain intensity and prognostic outcomes must be confirmed by the auditor in sample population. When there is disagreement between surgeon and anesthesiologists in evaluating the prognosis of patients, the auditor must solve this disagreement by discussion with evaluators. Data will be double-entered by two statisticians with limitation of access and locked during statistical analysis.
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
-
-
Chongqing
-
Chongqing, Chongqing, Čína, 400016
- China,Chongqing The First Affiliated Hospital of Chongqing Medical University
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- men or woman over 18 the years and younger than 65 years old who will receive selective laparoscopic cholecystectomy.
Exclusion Criteria:
- age below 18 years or over 65 years
- American Society of Anesthesiologists grade III or greater
- Diabetes
- chronic pain of any kind other than gallbladder disease
- allergic to local anesthetics
- cognitive impairment or communication problems
- peptic ulcer
- received opioids、NSAID or tranquilizers (treatment for over 1 wk before the cholecystectomy)
- history of alcohol or drug abuse
- the operation was converted to an open procedure
- gangrenous cholecystitis
- common bile duct exploration or insertion of a T-drain
- other invasive procedures
- severe hepatic or renal impairment
- post-operative severe complications(e.g. pyogenic infection)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: CTB group
Participants in this group will receive a single injection for calot's triangle block combined with PCIA post-operatively.
CTB will be conducted by bile duct needle and 1.0% 10 ml ropivacaine will be injection in calot's triangle when before surgical dissection.Participants in this group will also receive PCIA after surgery,the regimens of PCIA are included tramadol 800 mg, flurbiprofenaxetil 100 mg with normal saline added up to a volume of 80 ml in total.
|
CTB: A single injection of 1.0% 10ml ropivacaine by bile duct needle in calot's triangle when before surgical dissection.After surgery,participants in this group will also receive PCIA.
|
|
Aktivní komparátor: PCIA group
Participants in this group will receive PCIA post-operatively (tramadol 800 mg and flurbiprofen axetil 100mg with normal saline added up to a volume of 80ml in total ) .The PCIA pump was set up with a 5 ml loading dose, a 2 ml bolus dose, a 15 min lockout interval and background infusion at a rate of 1 ml/h.
|
Vzorec PCIA zahrnoval tramadol 800 mg, flurbiprofen axetil 100 mg s fyziologickým roztokem přidaným do celkového objemu 80 ml.
PCIA pumpa byla nastavena s 5 ml nasycovací dávkou, 2 ml bolusovou dávkou, 15minutovým blokovacím intervalem a infuzí pozadí rychlostí 1 ml/h.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Chronic post-surgical pain
Časové okno: 3 months post-operatively
|
Chronic post-surgical pain intensity will be measured as more than 3 months by numerical rating scale (NRS) for pain
|
3 months post-operatively
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Acute pain post-operatively
Časové okno: 2h,4h,6h,12h,24h, 48h post-operatively
|
Pain intensity will be measured by visual analogue scale(VAS)
|
2h,4h,6h,12h,24h, 48h post-operatively
|
|
Analgesic Rescue
Časové okno: from 2h to 48h post-operatively
|
The dosages of opioid or non-opioid analgesic rescue medications
|
from 2h to 48h post-operatively
|
|
Adverse events associated with post-operative analgesia
Časové okno: from 2h to 48h post-operatively
|
incomplete analgesia; nausea and vomiting; respiratory depression; over-sedation
|
from 2h to 48h post-operatively
|
|
moderate-severe pain
Časové okno: 3,6months postoperatively
|
Pain intensity will be measured by numerical rating scale (NRS)
|
3,6months postoperatively
|
|
chronic post-surgical pain
Časové okno: 6months postoperatively
|
chronic post-surgical pain intensity will be measured by numerical rating scale (NRS) for pain
|
6months postoperatively
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.
- Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.
- Katz J, Jackson M, Kavanagh BP, Sandler AN. Acute pain after thoracic surgery predicts long-term post-thoracotomy pain. Clin J Pain. 1996 Mar;12(1):50-5. doi: 10.1097/00002508-199603000-00009.
- Bisgaard T, Klarskov B, Rosenberg J, Kehlet H. Characteristics and prediction of early pain after laparoscopic cholecystectomy. Pain. 2001 Feb 15;90(3):261-269. doi: 10.1016/S0304-3959(00)00406-1.
- Joris J, Thiry E, Paris P, Weerts J, Lamy M. Pain after laparoscopic cholecystectomy: characteristics and effect of intraperitoneal bupivacaine. Anesth Analg. 1995 Aug;81(2):379-84. doi: 10.1097/00000539-199508000-00029.
- Bisgaard T, Rosenberg J, Kehlet H. From acute to chronic pain after laparoscopic cholecystectomy: a prospective follow-up analysis. Scand J Gastroenterol. 2005 Nov;40(11):1358-64. doi: 10.1080/00365520510023675.
- Blichfeldt-Eckhardt MR, Ording H, Andersen C, Licht PB, Toft P. Early visceral pain predicts chronic pain after laparoscopic cholecystectomy. Pain. 2014 Nov;155(11):2400-7. doi: 10.1016/j.pain.2014.09.019. Epub 2014 Sep 22.
- Lamberts MP, Lugtenberg M, Rovers MM, Roukema AJ, Drenth JP, Westert GP, van Laarhoven CJ. Persistent and de novo symptoms after cholecystectomy: a systematic review of cholecystectomy effectiveness. Surg Endosc. 2013 Mar;27(3):709-18. doi: 10.1007/s00464-012-2516-9. Epub 2012 Oct 6.
- Macrae WA. Chronic pain after surgery. Br J Anaesth. 2001 Jul;87(1):88-98. doi: 10.1093/bja/87.1.88. No abstract available.
- Ingelmo PM, Bucciero M, Somaini M, Sahillioglu E, Garbagnati A, Charton A, Rossini V, Sacchi V, Scardilli M, Lometti A, Joshi GP, Fumagalli R, Diemunsch P. Intraperitoneal nebulization of ropivacaine for pain control after laparoscopic cholecystectomy: a double-blind, randomized, placebo-controlled trial. Br J Anaesth. 2013 May;110(5):800-6. doi: 10.1093/bja/aes495. Epub 2013 Jan 4.
- Donatsky AM, Bjerrum F, Gogenur I. Intraperitoneal instillation of saline and local anesthesia for prevention of shoulder pain after laparoscopic cholecystectomy: a systematic review. Surg Endosc. 2013 Jul;27(7):2283-92. doi: 10.1007/s00464-012-2760-z. Epub 2013 Jan 26.
- Gurusamy KS, Nagendran M, Guerrini GP, Toon CD, Zinnuroglu M, Davidson BR. Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 13;(3):CD007337. doi: 10.1002/14651858.CD007337.pub3.
- Desautels SG, Slivka A, Hutson WR, Chun A, Mitrani C, DiLorenzo C, Wald A. Postcholecystectomy pain syndrome: pathophysiology of abdominal pain in sphincter of Oddi type III. Gastroenterology. 1999 Apr;116(4):900-5. doi: 10.1016/s0016-5085(99)70073-9.
- Shaffer E. Acalculous biliary pain: new concepts for an old entity. Dig Liver Dis. 2003 Jul;35 Suppl 3:S20-5. doi: 10.1016/s1590-8658(03)00089-6.
- SHAFIROFF BG, HINTON JW. Surgical anatomy of the choledochal nerves. Arch Surg (1920). 1950 May;60(5):944-952. doi: 10.1001/archsurg.1950.01250010967009. No abstract available.
- Womack NA, Crider RL. The Persistence of Symptoms Following Cholecystectomy. Ann Surg. 1947 Jul;126(1):31-55. doi: 10.1097/00000658-194707000-00004. No abstract available.
- Kellow JE. Sphincter of Oddi dysfunction type III: another manifestation of visceral hyperalgesia? Gastroenterology. 1999 Apr;116(4):996-1000. doi: 10.1016/s0016-5085(99)70086-7. No abstract available.
- Kurucsai G, Joo I, Fejes R, Szekely A, Szekely I, Tihanyi Z, Altorjay A, Funch-Jensen P, Varkonyi T, Madacsy L. Somatosensory hypersensitivity in the referred pain area in patients with chronic biliary pain and a sphincter of Oddi dysfunction: new aspects of an almost forgotten pathogenetic mechanism. Am J Gastroenterol. 2008 Nov;103(11):2717-25. doi: 10.1111/j.1572-0241.2008.02068.x. Epub 2008 Aug 5.
- Hickey OT, Burke SM, Hafeez P, Mudrakouski AL, Hayes ID, Shorten GD. Severity of acute pain after breast surgery is associated with the likelihood of subsequently developing persistent pain. Clin J Pain. 2010 Sep;26(7):556-60. doi: 10.1097/AJP.0b013e3181dee988.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CYYYMZ-005
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .