Improving perioperative pain management for laparoscopic surgery due to colon cancer using the ultrasound-guided Transmuscular Quadratus Lumborum block. A double blind, randomized, placebo controlled trial.

INTERVENTION: Trade Name: Ropivacain Pharmaceutical Form: Injection INN or Proposed INN: Ropivacain Other descriptive name: ROPIVACAINE HYDROCHLORIDE Concentration unit: % percent Concentration type: equal Concentration number: 7.5‐ Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Infiltration CONDITION: 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 Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: 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.; ; ; Primary end point(s): Total morphine consumption in the first 24 hours postoperatively (data from PCA pump and patient medical record). Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: 24 hours post surgery SECONDARY OUTCOME: 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. 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