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Clinical Trials/NCT03221491
NCT03221491
Completed
Not Applicable

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

Weifeng Tu1 site in 1 country90 target enrollmentJuly 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patient-Controlled Analgesia
Sponsor
Weifeng Tu
Enrollment
90
Locations
1
Primary Endpoint
Dezocine consumption by patient-controlled analgesia
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2016
End Date
June 30, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Weifeng Tu
Responsible Party
Sponsor Investigator
Principal Investigator

Weifeng Tu

Chief physician

Guangzhou General Hospital of Guangzhou Military Command

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 .

Outcomes

Primary Outcomes

Dezocine consumption by patient-controlled analgesia

Time Frame: At 24 hours after surgery

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

Secondary Outcomes

  • 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 Sites (1)

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