Comparison of Transversus Abdominis Plane and Quadratus Lumborum Blocks for Postoperative Analgesia in Laparoscopic Colorectal Resection for Colorectal Cancer or Diverticulosis Using Ropivacaine Hydrochloride

The primary objective of this study is to evaluate the efficacy of **Transversus abdominis plane** block and **Quadratus lumborum** block in managing pain during and after laparoscopic colectomy procedures. This is clinically relevant as effective pain management can significantly improve postoperative recovery and patient outcomes in individuals undergoing surgery for conditions such as colon cancer or diverticulosis.

Secondary objectives include comparing the extent, intensity, and duration of the anesthesia provided by these blocks. The study also aims to determine whether these regional anesthesia techniques offer superior postoperative pain control compared to traditional oral analgesics. Additionally, the investigation will assess the impact of these blocks on postoperative nausea, bowel function, length of hospital stay, and the potential for chronic pain development. Patient and healthcare provider satisfaction with pain management will also be evaluated.

The clinical trial involves participants undergoing **colorectal resection** due to either colorectal cancer or diverticulosis. The study aims to evaluate the effectiveness of different anesthesia techniques on postoperative pain management. The trial includes both male and female subjects, aged between 18 and 99 years, who are scheduled for a planned colorectal resection. The participants are generally in a stable health condition, as the study does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Lifestyle factors such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the efficacy of **transversus abdominis plane block** and **quadratus lumborum block** in managing pain during and after laparoscopic colon resection surgery. This is a Phase IV, randomized, double-blind, controlled trial involving adult patients aged 18 to 99 years who are scheduled for colon resection due to colon cancer or diverticulosis. The trial will utilize **ropivacaine hydrochloride** administered via perineural use as the investigational product. The trial is expected to run from March 7, 2022, to December 31, 2025.

Participants will undergo a screening visit to confirm eligibility based on inclusion criteria, which include being scheduled for colon resection. Exclusion criteria are not specified. Following the screening, eligible participants will be randomized to receive one of the two anesthetic techniques. The primary endpoint is the time from the administration of the block to the first report of pain greater than 3 on a numerical rating scale, at which point intravenous or oral oxycodone will be administered as per protocol. Secondary endpoints include pain assessment every four hours during the first 24 hours post-surgery, cumulative opioid requirement, incidence of nausea and vomiting, bowel function, patient satisfaction with the anesthetic technique, and any related complications.

Study visits will include follow-up assessments at regular intervals, with pain and satisfaction questionnaires administered at specified time points, including a control visit at four weeks post-surgery. The expected duration of participant involvement is up to four weeks post-surgery, with the possibility of early termination if adverse events or protocol deviations occur. The trial aims to provide comprehensive data on the effectiveness and safety of the anesthetic techniques in the specified surgical context.

The clinical trial involves the use of **ropivacaine hydrochloride**, a chemical compound classified under the ATC code N01BB09. The pharmaceutical form of the medication is denoted as PHF00231MIG. Ropivacaine hydrochloride is administered via **perineural use**. The maximum daily dose is 675 mg/ml, and the total dose should not exceed 675 mg/ml within a treatment period of one day. The medication is utilized for its anesthetic and analgesic properties, specifically in the context of managing pain associated with laparoscopic colorectal resection surgery.

In addition to the experimental treatment, standard-of-care therapies may be employed as necessary, although specific non-experimental treatments such as placebo or comparator treatments are not detailed in the provided data. Participant compliance with the dosing schedule will be monitored throughout the trial to ensure adherence to the prescribed regimen. The trial aims to evaluate the efficacy of transversus abdominis plane block and quadratus lumborum block in managing perioperative and postoperative pain.

Efficacy in this clinical trial will be assessed through both primary and secondary endpoints. The primary endpoint is the time from the administration of the **anesthetic block** to the first report by the patient of pain exceeding a score of 3, at which point intravenous or oral administration of oxycodone will be provided as per the study protocol. Secondary endpoints include several parameters: pain assessment every 4 hours during the first 24 hours post-surgery and then three times daily for one week, using the Numeric Rating Scale (NRS) from 0 to 10; cumulative opioid requirement during hospitalization; incidence of nausea and/or vomiting every 4 hours (yes/no); bowel function (functioning/not functioning); patient satisfaction with the anesthetic block on a scale from 0 to 10; complications related to the anesthetic block; surgical complications classified according to the Clavien-Dindo classification; and various questionnaires, including those from the Finnish Pain Research Society, BDI, and STAI, administered before surgery and four weeks post-surgery. Additionally, a nurse satisfaction survey and a one-week postoperative diary, along with a patient satisfaction survey, will be utilized. These assessments will provide comprehensive data on the efficacy of the pain management methods being compared in this trial.