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Comparison of Patient-Controlled Analgesia With Different Background Infusion

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03221491
Enrollment
90
Registered
2017-07-18
Start date
2016-07-01
Completion date
2017-06-30
Last updated
2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient-Controlled Analgesia

Keywords

Analgesia, Colorectal Surgery, Background Infusion

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.

Interventions

DEVICEPatient-Controlled Analgesia(PCA)

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

Sponsors

Weifeng Tu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frameDescription
Dezocine consumption by patient-controlled analgesiaAt 24 hours after surgeryThe total consumption of dezocine during 24 hours after surgery are recorded.

Secondary

MeasureTime frameDescription
The incidence rates of postoperative nausea and vomiting (PONV)At 24 hours and 48 hours after surgeryMeasure whether nausea and vomiting exist and the level of severity.
Change in ramsay sedation scoreAt 0, 2, 4, 8, 24, 48 and 72 hours after surgeryMeasure sedation level by using ramsay sedation score.
Change in pain scoreAt 0, 2, 4, 8, 24, 48 and 72 hours after surgeryPain scores at rest and movement are evaluated with a numeric rating scale (NRS)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026