Clinical trial NCT03221491: Comparison of Patient-Controlled Analgesia With Different Background Infusion
Official title: Comparison of Intravenous Patient-Controlled Analgesia With Different Background Infusion After Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient-Controlled Analgesia
Keywords: Analgesia
Colorectal Surgery
Background Infusion
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this study, the investigators investigated the efficacy, usefulness and analgesic consumption of three different patient-controlled analgesia(PCA) programmes:bolus dose alone without background infusion, bolus dose with low background infusion and bolus dose with high background infusion to evaluate postoperative analgesia for patients after laparoscopic colorectal surgery.

Detailed description: There have been many studies using patient-controlled analgesia (PCA) and opioids for postoperative analgesia.Patient-controlled analgesia with opioids is now widely used after surgery for the treatment of acute postoperative pain. This technique provides effective pain treatment, adjusts the dose according to personal need and keeps plasma analgesic levels at a constant level,but the incidence of opioid-induced side-effects still be reported frequently.A proper PCA programme may increase efficiency of analgesic and decrease incidence of analgesic-induced side-effects.

In this study, 90 patients who is undergoing elective laparoscopic colorectal surgery will be randomly allocated into three groups (no background infusion group(Group B0),low background infusion group(Group B1) and high background infusion group(Group B2)). Patients in all groups will be given a patient-controlled analgesia (PCA) pump in post anesthetic recovery unit (PACU) after surgery.The PCA programme of Group B0 is dezocine 0.6mg/kg, flubiprofen 3mg/kg, diluted into 120ml and administer at a background infusion of 0ml/h, and a bolus of 4ml, with a lock-out of 15min. The PCA protocol of Group B1 is dezocine 0.6mg/kg,flubiprofen 3mg/k diluted into 120ml and administer at a background infusion of 1ml/h, and a bolus of 2ml, with a lock-out of 15min.The PCA protocol of Group B2 is dezocine 0.6mg/kg,flubiprofen 3mg/k diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out of 15min.

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists(ASA) Ⅰ-Ⅱ patient undergoing laparoscopic colorectal surgery
2. Written informed consent from the patient or the relatives of the participating patient.
3. BMI:18～30kg/m2

Exclusion Criteria:

1. Mental illness or cannot communicate.;
2. A second operation during the study;
3. Lung infection or sleep apnea syndrome;
4. Renal failure;
5. Alcohol or drug abuse;
6. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug;
7. Long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history .

Primary outcomes:
measure: Dezocine consumption by patient-controlled analgesia
timeFrame: At 24 hours after surgery
Secondary outcomes:
measure: The incidence rates of postoperative nausea and vomiting (PONV)
timeFrame: At 24 hours and 48 hours after surgery
measure: Change in ramsay sedation score
timeFrame: At 0, 2, 4, 8, 24, 48 and 72 hours after surgery
measure: Change in pain score
timeFrame: At 0, 2, 4, 8, 24, 48 and 72 hours after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou General Hospital of Guangzhou Military Command
state: Guangdong
Study officials:
References:
citation: Doyle E, Harper I, Morton NS. Patient-controlled analgesia with low dose background infusions after lower abdominal surgery in children. Br J Anaesth. 1993 Dec;71(6):818-22. doi: 10.1093/bja/71.6.818.
citation: Yildiz K, Tercan E, Dogru K, Ozkan U, Boyaci A. Comparison of patient-controlled analgesia with and without a background infusion after appendicectomy in children. Paediatr Anaesth. 2003 Jun;13(5):427-31. doi: 10.1046/j.1460-9592.2003.01061.x.
citation: White I, Ghinea R, Avital S, Chazan S, Dolkart O, Weinbroum AA. Morphine at "sub-analgesic" background infusion rate plus low-dose PCA bolus control pain better and is as safe as twice a bolus-only PCA regimen: a randomized, double blind study. Pharmacol Res. 2012 Aug;66(2):185-91. doi: 10.1016/j.phrs.2012.03.016. Epub 2012 Apr 6.
citation: Hayes J, Dowling JJ, Peliowski A, Crawford MW, Johnston B. Patient-Controlled Analgesia Plus Background Opioid Infusion for Postoperative Pain in Children: A Systematic Review and Meta-Analysis of Randomized Trials. Anesth Analg. 2016 Oct;123(4):991-1003. doi: 10.1213/ANE.0000000000001244.