Comparison of Patient-Controlled Analgesia With Different Background Infusion

NCT03221491 | Completed

• 1 other identifier: Different Background Infusion
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient-Controlled Analgesia

Keywords

Analgesia; Colorectal Surgery; Background Infusion

Outcome Measures

Primary Outcomes (1)

• Dezocine consumption by patient-controlled analgesia

  The total consumption of dezocine during 24 hours after surgery are recorded.

  At 24 hours after surgery

Secondary Outcomes (3)

• The incidence rates of postoperative nausea and vomiting (PONV)

  At 24 hours and 48 hours after surgery

• Change in ramsay sedation score

  At 0, 2, 4, 8, 24, 48 and 72 hours after surgery

• Change in pain score

  At 0, 2, 4, 8, 24, 48 and 72 hours after surgery

Study Arms (3)

No Background Infusion Group(Group B0)

EXPERIMENTAL

Patients in Group B0 receive analgesic regimens using Patient-Controlled Analgesia(PCA) with background infusion 0ml/h.

Device: Patient-Controlled Analgesia(PCA)

Low Background Infusion Group(Group B1)

EXPERIMENTAL

Patients in Group B1 receive analgesic regimens using Patient-Controlled Analgesia(PCA) with background infusion 1ml/h.

Device: Patient-Controlled Analgesia(PCA)

High Background Infusion Group(Group B2)

EXPERIMENTAL

Patients in Group B2 receive analgesic regimens using Patient-Controlled Analgesia(PCA) with background infusion 2ml/h.

Device: Patient-Controlled Analgesia(PCA)

Interventions

Patient-Controlled Analgesia(PCA) DEVICE

Patients receive analgesic regimens using Patient-Controlled Analgesia(PCA) with different background infusion.

High Background Infusion Group(Group B2); Low Background Infusion Group(Group B1); No Background Infusion Group(Group B0)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Weifeng Tu: lead

Study Sites (1)

Guangzhou General Hospital of Guangzhou Military Command

Guangzhou, Guangdong, 510010, China

Location

Related Publications (4)

• 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.

  PMID: 8280546 BACKGROUND

• 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.

  PMID: 12791117 BACKGROUND

• 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.

  PMID: 22504462 BACKGROUND

• 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.

  PMID: 27065359 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 16, 2017
• First Posted: July 18, 2017
• Study Start: July 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)