Pain-relieving Methods After Laparoscopic Hemicolectomy

NCT05273281 | Unknown Phase 4

• 1 other identifier: R21075M
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain; Nerve Block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Opiate consumption

  72 hours or until discharge, whichever came first

• Post operative pain

  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

  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

  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 (3)

• Finnish pain query

  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

Study Arms (3)

TAQLA

EXPERIMENTAL

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

Procedure: Transabdominal plane block

TAQLB

EXPERIMENTAL

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

Procedure: Quadratus lumborum block

TAQLC

NO INTERVENTION

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

Interventions

Transabdominal plane block PROCEDURE

Peripheral nerve block

TAQLA

Quadratus lumborum block PROCEDURE

Peripheral nerve block

TAQLB

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult elective hemicolectomy patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jenni Kanerva, Phd

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

• Maija-Liisa Kalliomäki, PhD

  Tampere University Hospital

  STUDY DIRECTOR

Central Study Contacts

Maija-Liisa Kalliomäki, PhD

CONTACT

+358 3 311 69424; maija-liisa.kalliomaki@pshp.fi

Jenni Kanerva, PhD

CONTACT

+358 3 311 67415; jenni.kanerva@pshp.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 10, 2022
• Study Start: June 1, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)