Laparoscopic-guided TAP Block vs Epidural Analgesia

Post Operative Pain Clinical Trial

Official title:

Laparoscopic-Guided Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colorectal Laparoscopic Surgery. A Protocol for a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05214261
• Other study ID #: 112/2021
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2022
• Source: Oulu University Hospital
• Contact: Heikki Huhta, PhD
• Phone: +3583152011
• Email: heikki.huhta[@]ppshp.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The LAPTAP trial will provide evidence on preferred post-operative analgesia method in elective laparoscopic colon surgery.

Description:

In most previous studies TAP-block has been inserted by anesthesiologist under ultrasound guidance. TAP blockade can alternatively be performed by a surgeon with laparoscopic visual guidance during trocar placement by aiming injection into fascial plane between the internal oblique and transversus abdominis in the midaxillary line and repeated on the contralateral side. There is lack in studies comparing laparoscopic guided TAP-blockade versus epidural pain analgesia in elective laparoscopic colon surgery exist.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

IInclusion criteria

• Patients who undergo elective laparoscopic colorectal surgery for colorectal neoplasia, diverticulitis, and other diseases of the colon and rectosigmal area

• Patients able to provide informed written consent

• Patients capable of completing questionnaires at the time of consent

Exclusion criteria

• Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivacaine, fentanyl and/or oxycodone

• Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated international normal ratio (INR), anticoagulation, patient refusal, etc.) or TAP block (patient refusal)

• Urgent or emergent surgery precluding epidural catheter placement or TAP block

• Systemic Infection contraindicating epidural catheter placement or TAP block

• Rectal surgery

• Pregnant or suspected pregnancy

• Age < 18 years

• Planned open surgery

• Planned bowel stoma (protective diversion and/or permanent stoma)

• Unwillingness to participate in follow-up assessments

• Patients with severe chronic pain

• Known sensibility for opioid side effects

• i.v.-PCA is contraindicated (for example drug abuse)

• No informed consent

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Other:
• Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia
Patients in the TAP group will be given a laparoscopic-assisted TAP block with a total of 2mg/kg of 0.25% bupivacaine in the bilateral subcostal region into four spots of the bilateral subcostal region, two on both sides of the lateral abdomen between the anterior iliac spine and lower costal arch. The TAP block is performed after the first trocar placement before the insertion of other trocars and the beginning of the surgical intervention. In the control group epidural catheters will be placed using landmark- and loss-of-resistance techniques while the patient is on the operating table. Infusions of 4ml/h containing 0.125% levobupivacaine and 5.5 µg/mL fentanyl will be started with a CADD Solis VIP-infusion pump at the time of anesthesia induction.

Locations

Country	Name	City	State
Finland	Surgery and Intensive Care Research Unit	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of post-operative hospital stay after elective laparoscopic colorectal surgery.	The primary endpoint in this study is the length of post-operative hospital stay after elective laparoscopic colorectal surgery	Up to 1 month
Secondary	Overall operating theatre time	Overall operating theatre time	Up to 10 hours
Secondary	Post-operative morphine milligram equivalents recruitments	Post-operative morphine recruiments	Up to 1 month
Secondary	Visual analogue scale	The scores range 1 to 10. Higher scores indicates worse outcome in the treatment of anelgesia.	Up to 1 month
Secondary	Overall benefit of analgesia score (OBAS)	The scores range 0 - 24. Low OBAS socre indicates high benefit of analgesia	Up to 1 month
Secondary	Hospital readmission	Post-operative readmissions	30 and 90-day
Secondary	Time to first flatus	Post-operative flatus	Up to 1 month
Secondary	Time to first bowel movement	Post-operative bowel movement	Up to 1 month
Secondary	Time to post-operative mobilization	Post-operative mobilization	Up to 1 month
Secondary	Overall cost-effectiveness	Overall cost-effectiveness	Up to 6 months
Secondary	Post-operative complications related to interventions according to Clavien-Dindo classification	Post-operative complications	30 and 90-day