Clinical trial NCT05273281: Pain-relieving Methods After Laparoscopic Hemicolectomy
Official title: Pain-relieving Methods After Laparoscopic Hemicolectomy, Effects of Transabdominal Plain Block and Quadratus Lumborum Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Nerve Block
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effects of Transabdominal Plain Block and Quadratus Lumborum Block After Laparoscopic Hemicolectomy. The pain relief, bowel function and discharge.

Detailed description: This study is proposed to explore the effects of transabdominal plane block and quadratus lumborum block after laparoscopic hemicolectomy.

After laparoscopic hemicolectomy there is a need for good analgesia. When the analgesia is adequate the patients mobilisation, bowel function and discharge is faster. Earlier, epidural block has been used for the analgesia but now the hemicolectomy is laparoscopic procedure and there is no need for central block anymore. Still patients needs opioids after the operation. Because of the opioids side effects, there is a need to find better analgesia methods.

In this study investigators compare peripheral nerve blocks, transabdominal plane and quadratus lumborum, for analgesia after laparoscopic hemicolectomy. Also investigators are comparing these analgesia methods and traditional orally analgesics. Patients receive transabdominal or quadratus lumborum block after induction using ropivacaine 5 mg/ml 20 ml per side. The third group is a control group witch analgesia is taken care with traditional orally analgesics.

After surgery investigators follow postoperative pain, opiate consumption, bowel function, nausea and mobilisation.

Investigators coal is to find if the transabdominal plain block or quadratus lumborum block prefer traditional analgesia methods after laparoscopic hemicolectomy.

Eligibility criteria: Inclusion Criteria:

Adult elective hemicolectomy patients

Exclusion Criteria:

Age under 18 years Complicated diabetes mellitus Lack of finnish language skill and/or co-operation Chronic pain Use of drugs that significantly influences the metabolism of paracetamol or opiate Steroid medication in regular use Significant liver-, lung- or kidney disfunction

Primary outcomes:
measure: First need of opiate
timeFrame: 72 hours or until discharge, whichever came first
Secondary outcomes:
measure: Opiate consumption
timeFrame: 72 hours or until discharge, whichever came first
measure: Post operative pain
timeFrame: postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 32 hours, 40 hours, at 48 hours, at 56 hours, at 64 hours, at 72 hours, ones per day after discharge for seven days after operation
measure: Bowel function
timeFrame: postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 32 hours, 40 hours, at 48 hours, at 56 hours, at 64 hours, at 72 hours, ones per day after discharge for seven days after operation
measure: Nausea
timeFrame: postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 32 hours, 40 hours, at 48 hours, at 56 hours, at 64 hours, at 72 hours, ones per day after discharge for seven days after operation
Other outcomes:
measure: Finnish pain query
timeFrame: Baseline and 4 week after operation
measure: Beck´s depression inventory (BDI)
timeFrame: Baseline and 4 week after operation
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline and 4 week after operation
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Jenni Kanerva, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Maija-Liisa Kalliomäki, PhD
role: STUDY_DIRECTOR
References: