Postoperative pain following laparoscopic hemicolectomy or sigmoidectomy due to coloncancer MedDRA version: 20.0 Level: LLT Classification code 10009951 Term: Colon cancer NOS System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10078463 Term: Laparoscopic partial colectomy System Organ Class: 100000004865 MedDRA version: 20.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863
Conditions
Sponsors
Associate Professor, Consultant Jens Børglum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age > 18 • Scheduled for laparoscopic hemicolectomy or sigmoidectomy due to colon cancer • Have received thorough information, oral and written, and signed the “Informed Consent” form on participation in the trial • ASA 1-3 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: • Inability to cooperate • Inability to speak and understand Danish • Allergy to local anaesthetics or opioids • Daily intake of opioids (evaluated by the investigators) • Local infection at the site of injection or systemic infection • Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration • Pregnant* or breastfeeding • Daily use of oral or intravenous steroids • Known immune deficiency (evaluated by the investigators) • Other simultaneous or previous cancer diagnosis (except non-melanoma skin cancer)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Not applicable;Primary end point(s): Total morphine consumption in the first 24 hours postoperatively (data from PCA pump and patient medical record).;Main Objective: We wish to conduct a randomized, controlled and double blind study, comparing the effect of the TQL-block vs. placebo. Our aim with this study is to investigate the efficacy of the TQL block vs. placebo in patients undergoing laparoscopic surgery due to colon cancer. Our hypothesis is, that the bilateral TQL block will significantly reduce the opioid consumption during the first 24 postoperative hours and significantly reduce the Numerical Rating Scale (NRS) pain score (0-10) and opioid related side effects. We will furthermore obtain blood samples in the perioperative period. We will analyse them to characterize the differences in the immunologic stress response to colorectal surgery between the groups. ;Timepoint(s) of evaluation of this end point: 24 hours post surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Pain intensity (NRS 0-10) in the study period at 24 hours postoperatively. Pain scores a registered upon arrival at the PACU at T0 and again 30 min, 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 hours postoperative. Pain intensity will be registered during mobilization (sitting up) and at rest. In addition, NRS score will be recorded electronically on all morphine administrations, since all patients must enter their NRS score on the PCA pump display prior to administration of the PCA boluses. • Morphine consumption at 6, 12, 18 postoperative hours. • Duration of block (time to first opioid). • The degree of morphine-related side effects (PONV, itching, fatigue, etc.). • Time from surgery to first mobilization. • Quality of Recovery – 15 questionnaire at four time points (day -1, 1,2 and at the time of pathology results) the patients are asked to fill in the validated Quality of Recovery Questionnaire QoR-15(36). The QoR-15 questionnaire results in a score of 0–150. These outcome measures will be correlated with changes in immunologic outcome measures in the perioperative period. • Surgical complications classified using the Clavien-Dindo classification within the first 30 days after surgery To characterize the immunological response to surgery we obtain blood samples for analysis on postoperative day -1, 1, 2 and at the visit on day 10-14, where pathology results are given according to the study plan described in figure 2. We will perform the following analyses: • Whole blood gene expression profiling • Peripheral blood mononuclear cells (PBMC) • Cytokine assays ;Timepoint(s) of evaluation of this end point: From admittance the day before surgery, when the first blood sample is drawn and until 30 days post surgery. | — |
Countries
Denmark
Contacts
Public ContactJens Børglum
Department of Anaesthesiology, Zealand University Hospital, Roskilde
Outcome results
None listed