Clinical trial · Interventional
TQL-block for Laparoscopic Hemicolectomy
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Every year 350 patients undergo surgery due to colorectal cancer at Zealand University Hospital, Roskilde. The majority of the surgeries are performed using a minimal invasive laparoscopic technique where the bowl anastomosis is either hand sown or stapled. The procedure is performed, while the patient is under general anaesthesia. An observational prospective survey from 2016-17 of sixty patients undergoing hemicolectomy at Zealand University Hospital, Roskilde has shown, that even though the patients are subjected to a multimodal analgesic regimen, a substantial amount of opioids are being administered during the first 24 hours post surgery; i.e. 51.91 mg ± 36.22 mg (Mean ± SD) of oral morphine equivalents. Sixty-five percent of the patients receive opioids at the PACU. Their maximum pain score at the PACU is registered, using a numerical rating scale of 0-10, as 3.28 ± 2.65 (Mean ± SD). So it is obvious that there is room for improvement and a reduction in the use of postoperative opioids. Thus, there is a clearly defined research problem to explore. Currently ultrasound-guided nerveblocks are not part of the multimodal analgesic regimen. The primary aim of this study is to investigate the efficacy of the ultrasound-guided bilateral transmuscular quadratus lumborum block on reducing postoperative opioid consumption.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Pain | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetaminophen | Drug | — | UNRESOLVED |
| Blood samples | Diagnostic Test | — | UNRESOLVED |
| Morphine | Drug | — | UNRESOLVED |
| Orthostatic hypotension | Diagnostic Test | — | UNRESOLVED |
| Patient controlled analgesia | Device | — | UNRESOLVED |
| Quality of recovery-15 questionaire | Behavioral | — | UNRESOLVED |
| Ropivacaine | Drug | — | UNRESOLVED |
| Saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active
- description
- Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL ropivacaine 0,375% single shot. Every six hours postoperative, all patients are administered 1 g of acetaminophen. In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment. On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis. On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire. Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
- interventionNames
- Drug: Ropivacaine
- Drug: Acetaminophen
- Device: Patient controlled analgesia
- Drug: Morphine
- Diagnostic Test: Blood samples
- Behavioral: Quality of recovery-15 questionaire
- Diagnostic Test: Orthostatic hypotension
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 * Scheduled for laparoscopic or robot assisted 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 * American Society of Anaesthesiologist physical status classification, class 1-3 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) * Drug and/or substance abuse * 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) within the last five years (within the last five years added 28th nov 2019 after ethics committee approval).
References
Publications (36)
- BACKGROUNDÅrsrapporter [Internet]. [cited 2017 Jun 7]. Available from: http://www.dccg.dk/03_Publikation/02_arsraport.html
- BACKGROUNDKehlet H. Postoperative opioid sparing to hasten recovery: what are the issues? Anesthesiology. 2005 Jun;102(6):1083-5. doi: 10.1097/00000542-200506000-00004. No abstract available. PMID 15915017
- BACKGROUNDSondergaard ES, Gogenur I. [Oxidative stress may cause metastatic disease in patients with colorectal cancer]. Ugeskr Laeger. 2015 Apr 27;177(18):857-60. Danish. PMID 26539573
- BACKGROUNDGogenur M, Watt SK, Gogenur I. [Improved immunologic response after laparoscopic versus open colorectal cancer surgery]. Ugeskr Laeger. 2015 Jul 13;177(29):V12140763. Danish. PMID 26239962
- BACKGROUNDSun Y, Li T, Gan TJ. The Effects of Perioperative Regional Anesthesia and Analgesia on Cancer Recurrence and Survival After Oncology Surgery: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):589-98. doi: 10.1097/AAP.0000000000000273. PMID 26263074
- BACKGROUNDBorglum J, Jensen K, Christensen AF, Hoegberg LC, Johansen SS, Lonnqvist PA, Jansen T. Distribution patterns, dermatomal anesthesia, and ropivacaine serum concentrations after bilateral dual transversus abdominis plane block. Reg Anesth Pain Med. 2012 May-Jun;37(3):294-301. doi: 10.1097/AAP.0b013e31824c20a9. PMID 22476239
- BACKGROUNDBorglum J, Maschmann C, Belhage B, Jensen K. Ultrasound-guided bilateral dual transversus abdominis plane block: a new four-point approach. Acta Anaesthesiol Scand. 2011 Jul;55(6):658-63. doi: 10.1111/j.1399-6576.2011.02430.x. Epub 2011 Apr 4. PMID 21463262
- BACKGROUNDJensen K, Baek N, Jensen JT, Brglum J. Bilateral dual transversus abdominis plane block providing surgical anaesthesia for abdominal wall surgery. Anaesthesia. 2013 Jan;68(1):106-8. doi: 10.1111/anae.12103. No abstract available.