An interventional study of Lidocaine and Control in Thoracic Surgery, Video-Assisted, Lidocaine and Pain, Postoperative, sponsored by Guangzhou First People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-11-07.
Sponsored by Guangzhou First People's Hospital · Not applicable, Interventional, and Treatment
This study seeks to investigate lidocaine infusion to reduce postthoractomy pain syndrome after thoracic Surgery
Postthoracotomy pain syndrome (PPS) is defined as a persistent and/or recurrent pain or burning sensation along the thoracotomy scar at 3 months after surgery. The pain is very significant, given that 3 to 5% of postthoractomy patients report it as being severe, and approximately 50% of patients report limitations in their activities of daily living. Little is known about the origin of this pain, but it seems that the intensity of acute postoperative pain is the best predictor of it. Lidocaine infusion could be a possible approach to reducing the prevalence of PPS. Recently, a meta-analysis concluded a modest but statistically significant reduction of pain severity in the first four postoperative hours measured by the visual analogue scale (mean difference, -0.84; 95% CI, -1.10 to -0.59). However, a more recent meta-analysis found that only limited clinical data and biological plausibility support lidocaine infusions for the prevention of postoperative persistent pain (odds ratio, 0.29; 95% CI, 0.18 to 0.48). This study was designed to investigate whether lidocaine infusion after video-assisted thoracoscopic surgery (VATS) would lower PPS at postoperative 3 and 6 month.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's planned enrollment of 72 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Guangzhou First People's Hospital is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Lidocaine treatment
Drug: Lidocaine
Placebo treatment
Drug: Control
Infusion of 2% lidocaine hydrochloride at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.
Also known as: intravenous lidocaine infusion
Infusion of normal saline at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.
Also known as: normal saline control
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.
Time frame: At 3 months after surgery.
Postoperative acute pain
Use numeric rating scale (NRS) to assess the postoperative acute pain
Time frame: postoperative days 1 and 2.
Sedation
Use numeric rating scale (NRS) to asses
Time frame: postoperative days 1 and 2.
Postoperative nausea and vomiting (PONV) nausea
Use numeric rating scale (NRS) to assess
Time frame: postoperative days 1 and 2.
Fatigue
Use numeric rating scale (NRS) to assess
Time frame: postoperative days 1 and 2.
Occurrence of chronic pain at 6-month
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.
Time frame: At 6 months after surgery.
Postthoracotomy ipsilateral shoulder pain
Use numeric rating scale (NRS) to assess
Time frame: postoperative days 1 and 2.
Plan to share: No
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Guangzhou First People's Hospital