Objective of Study
Popularity of laparoscopic surgery owes largely to improved patient reported outcomes (PRO). Postoperative pain and fatigue are important indices of return to activity based quality of life PROs. Turmeric has been successfully used in India as a monotherapy for traumatic pain & fatigue. Curcumin, the active ingredient of turmeric has anti-inflammatory / anti-oxidant & tissue modulation / healing properties reported even at nanomolar levels without any toxicity & a wide therapeutic window. We studied the effect of curcumin on pain and postoperative fatigue in patients of Laparoscopic cholecystectomy (LC), an index Laparoscopic procedure.
Methods and procedures
From July – September 2009 fifty unselected consecutive day care LC candidates were enrolled for this prospective, double blind randomized placebo (well matched & label blind) controlled study with ethics and informed consent protocol. Pregnant / lactating ladies, patient withpsychosis/ neuropathic pain / alcohol or drug dependence / on self-administered analgesics /on regular analgesics or immunosuppressive or cytotoxic or steroid therapy were excluded.
Any perioperative adverse event was the withdrawal criteria. A standard general anesthesia and perioperative analgesia protocol was followed for the LCs. No analgesic was prescribed at discharge except for either of the label blinded curcumin / placebo in 6 hourly dosage. Patients were asked to maintain pain / fatigue / any adverse event diaries based upon 100 point visual analog scale (VAS) for pain and 10-point interval rating scale (IRS) for fatigue. Paracetamol 650 mg was the rescue analgesic. Patients were asked to record the number of tablets used during the 3 weeks. Patients were followed up on 3rd day (D3), 1st week (W1), 2nd week (W2) and 3rd week (W3) for prospective data. The random labels assigned were opened & entered for the corresponding patients only at the end of study for analysis.
The patients in the study (n=25) and the control group (n=25) were well matched for demographics, co-morbidity and gallbladder inflammation parameters. There was no withdrawal. All patients were pain free at W3 follow up. Analgesic tablet usage in 3 weeks was 7 (5-11) in the study group versus 39 (18-79) in the control group.
Table showing the mean (range) scores of post-operative pain & fatigue.
|Group||Pain Scores||Fatigue Scores|
Turmeric (Curcumin) improves the postoperative pain & fatigue related PROs in patients of laparoscopic cholecystectomy. In view of encouraging results, benefits of a non-toxic common food ingredient i.e. turmeric (Curcumin) need to be studied in large, multi-centric, multi-ethnic studies.
Session: Podium Presentation
Program Number: S010