Pain-relieving Methods After Laparoscopic Hemicolectomy

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05273281
• Other study ID #: R21075M
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2022
• Est. completion date: February 1, 2025

Study information

• Verified date: March 2022
• Source: Tampere University Hospital
• Contact: Maija-Liisa Kalliomäki, PhD
• Phone: +358 3 311 69424
• Email: maija-liisa.kalliomaki[@]pshp.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 255
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Nerve Block
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Transabdominal plane block
Peripheral nerve block
• Quadratus lumborum block
Peripheral nerve block

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Beck´s depression inventory (BDI)		Baseline and 4 week after operation
Other	The State-Trait Anxiety Inventory (STAI)		Baseline and 4 week after operation
Primary	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	Opiate consumption	Total opiate consumption after surgery	72 hours or until discharge, whichever came first
Secondary	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
Secondary	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
Secondary	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