Comparison of Patient-Controlled Analgesia With Different Background Infusion

Patient-Controlled Analgesia Clinical Trial

Official title:

Comparison of Intravenous Patient-Controlled Analgesia With Different Background Infusion After Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03221491
• Other study ID #: Different Background Infusion
• Status: Completed
• Phase: N/A
• First received: July 16, 2017
• Last updated: July 18, 2017
• Start date: July 1, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: July 2017
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. American Society of Anesthesiologists(ASA) ?-? 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 .

Related Conditions & MeSH terms

• Patient-Controlled Analgesia

Intervention

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

Locations

Country	Name	City	State
China	Guangzhou General Hospital of Guangzhou Military Command	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Weifeng Tu

Country where clinical trial is conducted

China, 

References & 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dezocine consumption by patient-controlled analgesia	The total consumption of dezocine during 24 hours after surgery are recorded.	At 24 hours after surgery
Secondary	The incidence rates of postoperative nausea and vomiting (PONV)	Measure whether nausea and vomiting exist and the level of severity.	At 24 hours and 48 hours after surgery
Secondary	Change in ramsay sedation score	Measure sedation level by using ramsay sedation score.	At 0, 2, 4, 8, 24, 48 and 72 hours after surgery
Secondary	Change in pain score	Pain scores at rest and movement are evaluated with a numeric rating scale (NRS)	At 0, 2, 4, 8, 24, 48 and 72 hours after surgery