Chronic Pain Clinical Trial
— LIPAHOfficial title:
Lidocaine Infusion for Pain After Herniotomy (LIPAH), A Randomized Placebo-controlled Trial (LIPAH Trial)
This study seeks to investigate lidocaine infusion to reduce occurrence of chronic postoperative pain at 3-month after inguinal herniotomy
Status | Recruiting |
Enrollment | 180 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patients scheduled to undergo unilateral inguino herniotomy Exclusion Criteria: - (1)ASA classification status III or above - (2)Body weight<35kg - (3)Liver cirrhosis - (4)A history of previous herniotomy - (5)Pregnancy - (6)Severe arrhythmia - (7)Congestive heart failure - (8)Opioid or steroid use 6 months before surgery - (9)Allergy to lidocaine - (10)Chronic pain syndrome (any type) - (11)Emergency surgery - (12)Incapacity to give an informed consent, Visual dysfunction or severe mental disorders |
Country | Name | City | State |
---|---|---|---|
China | Guangzhou First People's Hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangzhou First People's Hospital |
China,
Aasvang E, Kehlet H. Chronic postoperative pain: the case of inguinal herniorrhaphy. Br J Anaesth. 2005 Jul;95(1):69-76. Epub 2004 Nov 5. Review. — View Citation
Bailey M, Corcoran T, Schug S, Toner A. Perioperative lidocaine infusions for the prevention of chronic postsurgical pain: a systematic review and meta-analysis of efficacy and safety. Pain. 2018 Sep;159(9):1696-1704. doi: 10.1097/j.pain.0000000000001273. — View Citation
Dworkin RH, Turk DC, Peirce-Sandner S, Baron R, Bellamy N, Burke LB, Chappell A, Chartier K, Cleeland CS, Costello A, Cowan P, Dimitrova R, Ellenberg S, Farrar JT, French JA, Gilron I, Hertz S, Jadad AR, Jay GW, Kalliomäki J, Katz NP, Kerns RD, Manning DC, McDermott MP, McGrath PJ, Narayana A, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Reeve BB, Rhodes T, Sampaio C, Simpson DM, Stauffer JW, Stucki G, Tobias J, White RE, Witter J. Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations. Pain. 2010 May;149(2):177-93. doi: 10.1016/j.pain.2010.02.018. Epub 2010 Mar 6. Review. — View Citation
Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2. Review. Update in: Cochrane Database Syst Rev. 2018 Jun 04;6:CD009642. — View Citation
Wang JL, Zhang WJ, Gao M, Zhang S, Tian DH, Chen J. A cross-cultural adaptation and validation of the short-form McGill Pain Questionnaire-2: Chinese version in patients with chronic visceral pain. J Pain Res. 2017 Jan 5;10:121-128. doi: 10.2147/JPR.S116997. eCollection 2017. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of chronic pain | Chronic pain was assessed in accordance with the IMMPACT recommends in the domains of: (1) absence or presence of pain in the area of the surgery, (2) clinically important (NRS = 4 on a 0- to 10-point scale) daily average pain, (3) clinically important pain at rest, (4) clinically important pain intensity upon movement or activity, (5) pain qualities, and (6) physical and emotional functioning. | At 3 months after surgery. | |
Secondary | Postoperative acute pain | Use an 11-point Numeric Rating Scale (NRS) to assess the postoperative acute pain | Up to 48 hours after surgery | |
Secondary | Sedation | Use an 0- to 10-point Numeric Rating Scale to asses | Up to 48 hours after surgery | |
Secondary | Postoperative nausea and vomiting (PONV) | Use an 0- to 10-point Numeric Rating Scale to asses | Up to 48 hours after surgery | |
Secondary | Fatigue | Use an 0- to 10-point Numeric Rating Scale to asses | Up to 48 hours after surgery | |
Secondary | Chronic pain at 6-month after surgery | Chronic pain was assessed in accordance with the IMMPACT recommends in the domains of: (1) absence or presence of pain in the area of the surgery, (2) clinically important (NRS = 4 on a 0- to 10-point scale) daily average pain, (3) clinically important pain at rest, (4) clinically important pain intensity upon movement or activity, (5) pain qualities, and (6) physical and emotional functioning. | At 6 months after surgery. | |
Secondary | Chronic pain at 12-month after surgery | Chronic pain was assessed in accordance with the IMMPACT recommends in the domains of: (1) absence or presence of pain in the area of the surgery, (2) clinically important (NRS = 4 on a 0- to 10-point scale) daily average pain, (3) clinically important pain at rest, (4) clinically important pain intensity upon movement or activity, (5) pain qualities, and (6) physical and emotional functioning. | At 12 months after surgery. |
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