A Single-Blind Randomized Controlled Trial on the Impact of IV PCA, IV PCA with Surgical Rectus Sheath Block, and IV PCA with Laparoscopic Bilateral Transversus Abdominis Plane Block on Postoperative Quality of Recovery in Minimally Invasive Colorectal Cancer Surgery

JRCT ID: jRCT1031240153

Registered date:11/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colorectal neoplasms
• Date of first enrollment: 11/06/2024
• Target sample size: 306
• Study type: Interventional
• Intervention(s): Surgical Rectal sheath block and Laparoscopic Bilateral dual TAP block

Outcome(s)

• Primary Outcome: QoR-15 scores at 24 hours postoperatively

Secondary Outcome

VAS scores at rest and during coughing at 2, 6, 12, 24, and 48 hours postoperatively
QoR-15 scores at 48 hours postoperatively
Time from surgery to the first administration of analgesics
Total analgesic consumption within 48 hours postoperatively
Total opioid consumption within 48 hours postoperatively
Total antiemetic consumption within 48 hours postoperatively
Duration of surgery
Postoperative complications
Length of postoperative hospital stay
Adverse events occurring during the administration of SRSB or BD-TAP

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Disease (cancer type)
Endoscopic biopsy from the primary lesion has histologically diagnosed a malignant tumour.
2) Extent of disease
The main site of tumour occupation, as determined comprehensively by endoscopy and preoperative imaging (enterography or upper abdominal and pelvic CT), is one of the following: appendix (V), cecum (C), ascending colon (A), transverse colon (T), descending colon (D), sigmoid colon (S), Rectosigmoid colon (RS), upper rectum (Ra), lower rectum (Rb). Any of the following.
3) Age
The patient is at least 18 years old.
4) PS
ASA-PS is 1-3.
5) Organ function (laboratory tests)
All of the following conditions must be fulfilled: (All laboratory tests must be completed before 56 days of enrolment). (All laboratory tests must be the most recent within 56 days before enrolment. Tests on the same day of the week 8 weeks before enrolment are acceptable).
(i) White blood cell count >=3,000/mm3
(ii) Platelet count >=100,000/mm3
(iii) AST <= 100 IU/L, ALT <= 100 IU/L
(iv) Total bilirubin <= 2.0 g/dL
Serum creatinine <= 1.5 mg/dL
6) Written informed consent has been obtained from the patient to participate in the study: Written informed consent

Exclude criteria

Patients scheduled for abdominoperineal resection.
Patients who underwent abdominoperineal resection based on intraoperative findings.
Patients who have difficulty taking oral medications.
Patients who are chronically using opioids (using an equivalent of 60 mg/day or more of morphine daily or within one month before surgery).
Patients under treatment (such as medication) for chronic pain (e.g., postherpetic neuralgia).
Patients with a possibility of conversion to open surgery and scheduled for epidural anesthesia.
Patients who underwent conversion to open surgery based on intraoperative findings.
Patients with allergies to local anesthetics or non-opioid analgesics.
Patients with skin diseases at the puncture site or on the abdomen.
Patients with decreased cardiopulmonary function, making pneumoperitoneum difficult.
Patients with decreased cardiopulmonary function and joint movement disorders, making intraoperative position changes difficult.
Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding.
Patients with psychiatric disorders or symptoms that make participation in the trial difficult.
Other patients whom the primary physician deems difficult to participate in this trial.

Related Information

• Primary Sponsor: Kanemitsu Yukihide