Comparison of Patient-Controlled Analgesia With Different Background Infusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Patient Re-education vs. Background Morphine to IV-PCA in Patient With Unsatisfactory Analgesia Post Laparotomy

NCT02523846

Post-operative Pain

UNKNOWN PHASE4

Intrathecal Morphine Analgesia vs. Continuous Epidural Analgesia vs. Systemic Analgesia in Colorectal Surgery.

NCT03007121

Analgesia, Patient-Controlled Epidural Analgesia Anesthesia; Spinal +3 more

COMPLETED PHASE4

Effectiveness of Pain Control and Adverse Reactions After Intravenous PCA in Chinese Population

NCT05884021

Postoperative Pain, Acute

COMPLETED

Effectiveness of Transverse Abdominus Plane Catheter Blocks to Patient-controlled Analgesia in Laparoscopic Colon Resections

NCT01592630

Colorectal Disorders Observation of Neuromuscular Block

WITHDRAWN PHASE3

Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study

NCT03236051

Gastric Cancer

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patient-Controlled Analgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No Background Infusion Group(Group B0)

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

Group Type EXPERIMENTAL

Patient-Controlled Analgesia(PCA)

Intervention Type DEVICE

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

Low Background Infusion Group(Group B1)

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

Group Type EXPERIMENTAL

Patient-Controlled Analgesia(PCA)

Intervention Type DEVICE

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

High Background Infusion Group(Group B2)

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

Group Type EXPERIMENTAL

Patient-Controlled Analgesia(PCA)

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Patient-Controlled Analgesia(PCA)

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 .

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No