Pain-relieving Methods After Laparoscopic Hemicolectomy

Pain-relieving Methods After Laparoscopic Hemicolectomy, Effects of Transabdominal Plain Block and Quadratus Lumborum Block

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Nerve Block
• Intervention / Treatment: Procedure: Transabdominal plane block; Procedure: Quadratus lumborum block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 255
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Maija-Liisa Kalliomäki, PhD; Phone Number: +358 3 311 69424; Email: maija-liisa.kalliomaki@pshp.fi
• Study Contact Backup: Name: Jenni Kanerva, PhD; Phone Number: +358 3 311 67415; Email: jenni.kanerva@pshp.fi

Study Locations

• Finland
  • Tampere, Finland, 33521
    • Recruiting
    • Tampere University Hospital
    • Contact: Maija-Liisa Kalliomäki, PhD; Phone Number: +358 3 311 69424; Email: maija-liisa.kalliomaki@pshp.fi
    • Contact: Jenni Kanerva, PhD; Phone Number: +358 3 311 67415; Email: jenni.kanerva@pshp.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TAQLA; Transabdominal plain block -group. Ropivacaine Hydrochloride Inj 5mg/ml 20 ml perineurally per side.	Procedure: Transabdominal plane block; Peripheral nerve block
EXPERIMENTAL: TAQLB; Quadratus lumborum block -group. Ropivacaine Hydrochloride Inj 5mg/ml 20 ml perineurally per side.	Procedure: Quadratus lumborum block; Peripheral nerve block
NO_INTERVENTION: TAQLC; Control group. Pain relief only with intravenous and peroral drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First need of opiate	Time after surgery when the patient needs opiate for the first time	72 hours or until discharge, whichever came first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opiate consumption	Total opiate consumption after surgery	72 hours or until discharge, whichever came first
Post operative pain	Numeric rating scale NRS 0-10, verbally description after discharge	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
Bowel function	Verbally description: non/gas/function	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
Nausea	Verbally description: yes/no	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Finnish pain query	This query has first made by the finnish association for the study of pain. It has been modified for this research. It includes questions how pain infects on the daily life (sleeping, exercising, ability to work, concentration et cetera), how often the pain appears and how intense the pain is (scale 0-10). There is a picture of body where patients marks the pain points.	Baseline and 4 week after operation
Beck´s depression inventory (BDI)		Baseline and 4 week after operation
The State-Trait Anxiety Inventory (STAI)		Baseline and 4 week after operation

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Investigators: Principal Investigator: Jenni Kanerva, Phd, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2022
• Primary Completion (ANTICIPATED): February 1, 2025
• Study Completion (ANTICIPATED): February 1, 2025

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (ACTUAL): March 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: R21075M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No