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Comparison of Patient-Controlled Analgesia With Different Background Infusion

Primary Purpose

Patient-Controlled Analgesia

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Patient-Controlled Analgesia(PCA)

About this trial

This is an interventional health services research trial for Patient-Controlled Analgesia focused on measuring Analgesia, Colorectal Surgery, Background Infusion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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 .

Sites / Locations

Guangzhou General Hospital of Guangzhou Military Command

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

No Background Infusion Group(Group B0)

Low Background Infusion Group(Group B1)

High Background Infusion Group(Group B2)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Dezocine consumption by patient-controlled analgesia

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

Secondary Outcome Measures

The incidence rates of postoperative nausea and vomiting (PONV)

Measure whether nausea and vomiting exist and the level of severity.

Change in ramsay sedation score

Measure sedation level by using ramsay sedation score.

Change in pain score

Pain scores at rest and movement are evaluated with a numeric rating scale (NRS)

Full Information

NCT ID

NCT03221491

First Posted

July 16, 2017

Last Updated

July 18, 2017

Sponsor

Weifeng Tu

1. Study Identification

Unique Protocol Identification Number

NCT03221491

Brief Title

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

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

July 1, 2016 (Actual)

Primary Completion Date

June 30, 2017 (Actual)

Study Completion Date

June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Weifeng Tu

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patient-Controlled Analgesia

Keywords

Analgesia, Colorectal Surgery, Background Infusion

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

No Background Infusion Group(Group B0)

Arm Type

Experimental

Arm Description

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

Arm Title

Low Background Infusion Group(Group B1)

Arm Type

Experimental

Arm Description

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

Arm Title

High Background Infusion Group(Group B2)

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Patient-Controlled Analgesia(PCA)

Intervention Description

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

Primary Outcome Measure Information:

Title

Dezocine consumption by patient-controlled analgesia

Description

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

Time Frame

At 24 hours after surgery

Secondary Outcome Measure Information:

Title

The incidence rates of postoperative nausea and vomiting (PONV)

Description

Measure whether nausea and vomiting exist and the level of severity.

Time Frame

At 24 hours and 48 hours after surgery

Title

Change in ramsay sedation score

Description

Measure sedation level by using ramsay sedation score.

Time Frame

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

Title

Change in pain score

Description

Pain scores at rest and movement are evaluated with a numeric rating scale (NRS)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 .

Facility Information:

Facility Name

Guangzhou General Hospital of Guangzhou Military Command

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510010

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

8280546

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.

Results Reference

background

PubMed Identifier

12791117

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.

Results Reference

background

PubMed Identifier

22504462

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.

Results Reference

background

PubMed Identifier

27065359

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.

Results Reference

background

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Comparison of Patient-Controlled Analgesia With Different Background Infusion

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