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Pain-relieving Methods After Laparoscopic Hemicolectomy

Primary Purpose

Postoperative Pain, Nerve Block

Status
Recruiting
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Transabdominal plane block
Quadratus lumborum block
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tampere University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

TAQLA

TAQLB

TAQLC

Arm Description

Transabdominal plain block -group. Ropivacaine Hydrochloride Inj 5mg/ml 20 ml perineurally per side.

Quadratus lumborum block -group. Ropivacaine Hydrochloride Inj 5mg/ml 20 ml perineurally per side.

Control group. Pain relief only with intravenous and peroral drugs.

Outcomes

Primary Outcome Measures

First need of opiate
Time after surgery when the patient needs opiate for the first time

Secondary Outcome Measures

Opiate consumption
Total opiate consumption after surgery
Post operative pain
Numeric rating scale NRS 0-10, verbally description after discharge
Bowel function
Verbally description: non/gas/function
Nausea
Verbally description: yes/no

Full Information

First Posted
February 25, 2022
Last Updated
November 4, 2022
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05273281
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Nerve Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
255 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAQLA
Arm Type
Experimental
Arm Description
Transabdominal plain block -group. Ropivacaine Hydrochloride Inj 5mg/ml 20 ml perineurally per side.
Arm Title
TAQLB
Arm Type
Experimental
Arm Description
Quadratus lumborum block -group. Ropivacaine Hydrochloride Inj 5mg/ml 20 ml perineurally per side.
Arm Title
TAQLC
Arm Type
No Intervention
Arm Description
Control group. Pain relief only with intravenous and peroral drugs.
Intervention Type
Procedure
Intervention Name(s)
Transabdominal plane block
Intervention Description
Peripheral nerve block
Intervention Type
Procedure
Intervention Name(s)
Quadratus lumborum block
Intervention Description
Peripheral nerve block
Primary Outcome Measure Information:
Title
First need of opiate
Description
Time after surgery when the patient needs opiate for the first time
Time Frame
72 hours or until discharge, whichever came first
Secondary Outcome Measure Information:
Title
Opiate consumption
Description
Total opiate consumption after surgery
Time Frame
72 hours or until discharge, whichever came first
Title
Post operative pain
Description
Numeric rating scale NRS 0-10, verbally description after discharge
Time Frame
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
Title
Bowel function
Description
Verbally description: non/gas/function
Time Frame
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
Title
Nausea
Description
Verbally description: yes/no
Time Frame
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 Pre-specified Outcome Measures:
Title
Finnish pain query
Description
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.
Time Frame
Baseline and 4 week after operation
Title
Beck´s depression inventory (BDI)
Time Frame
Baseline and 4 week after operation
Title
The State-Trait Anxiety Inventory (STAI)
Time Frame
Baseline and 4 week after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maija-Liisa Kalliomäki, PhD
Phone
+358 3 311 69424
Email
maija-liisa.kalliomaki@pshp.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Jenni Kanerva, PhD
Phone
+358 3 311 67415
Email
jenni.kanerva@pshp.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenni Kanerva, Phd
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maija-Liisa Kalliomäki, PhD
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maija-Liisa Kalliomäki, PhD
Phone
+358 3 311 69424
Email
maija-liisa.kalliomaki@pshp.fi
First Name & Middle Initial & Last Name & Degree
Jenni Kanerva, PhD
Phone
+358 3 311 67415
Email
jenni.kanerva@pshp.fi

12. IPD Sharing Statement

Plan to Share IPD
No

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Pain-relieving Methods After Laparoscopic Hemicolectomy

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