Clinical effectiveness of Transversus Abdominis Plane (TAP) block administration following laparoscopic colorectal surgery for effective pain relief: a double blinded randomised controlled trial

Phase 1

• Conditions: Pain relief following laparoscopic colorectal resectional surgery (Benign and malignant); MedDRA version: 14.1Level: LLTClassification code 10002182Term: AnalgesiaSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: PTClassification code 10036276Term: Postoperative analgesiaSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: LLTClassification code 10021415Term: Immediate postoperative analgesiaSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2010-024402-35-GB
• Lead Sponsor: Sussex NHS Research Consortium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-02
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Inclusion Criteria: All patients undergoing elective laparoscopic colorectal resectional procedures Patients undergoing colorectal procedure with or without stoma Patients of either sex Adult patients above 16 years of age Patients of any BMI Patients who have had neoadjuvant radiotherapy or chemoradiotherpay Patients of ASA I, ASA II and ASA III anaesthetic risk Patients who agree and sign the consent form to participate in this trial.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Exclusion Criteria: Patients unable to give consent or refuse to participate in this study Patients under the age of 16 years Patients who are pregnant Patients undergoing an emergency operation Patients undergoing the procedure as a postoperative complication Procedures performed for complications or adverse events during the same hospital episode or performed in circumstances related to a primary and initial procedure. Patient is allergic to any medication used in local infiltration and/or morphine Patients with chronic pain syndrome Patients with severe hypotension such as cardiogenic or hypovolaemic shock Patients with severe hypertension.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does the use of a transversus abdominis plane (TAP) block reduce the total hospital length of stay after laparoscopic colorectal surgery?;Secondary Objective: Does the use of transversus abdominis plane blocks provide beneficial functional effects of reduced morphine such as time to first solid meal, time to mobilisation, reduction of nausea, vomiting and sedation? Does the use of transversus abdominis blocks provide adequate pain relief following laparoscopic colorectal surgery?;Primary end point(s): The primary outcome measure is length of hospital stay. (in days);Timepoint(s) of evaluation of this end point: Start point: Operative intervention End point: Discharge from hospital

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): We will measure possible functional effects of reduced morphine usage. The variables investigated will be: Pain scores Nausea and vomiting levels Sedation levels Mood score (POMS) Complications of interventions Time to first meal Time to first mobilisation;Timepoint(s) of evaluation of this end point: These variables will be assessed in the 48 hour postoperative period Length of stay will be assessed upon discharge