The Analgesic Efficacy of Ultrasound Guided Transversus Abdominal Plane Block After Abdominal Cancer Surgeries

NCT03165383 | Completed DMC

• 1 other identifier: RGCI & RC
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Effective postoperative pain control results in decreased cardiac and pulmonary complications, patient satisfaction and early mobilization. A prospective, randomized comparative study was done of analgesic efficacy, opioid requirement and side effects in patients undergoing lower abdominal cancer surgeries. In Study Group Ultrasound guided Transversus Abdominis Plane (TAP) block was given and control Group no TAP block was given. Patient controlled analgesia (PCA) with intravenous morphine was given to both group patients, and total good PCA demands in both the groups was studied.

Conditions

Abdominal Cancer

Keywords

Transverse Abdominis Plane (TAP) Block; Patient Control Analgesia (PCA)

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Pain Score in PACU in Transversus Abdominis Plane Block and Control Patient Group.

  In the PACU Visual Analogue Pain Score will be noted at rest and on knee flexion up to 24 hours.

  up to 24 hours

Secondary Outcomes (1)

• Total and Good demands for PCA IV Morphine in milligrams in both the groups.

  up to 24 hours

Study Arms (2)

Transversus Abdominis Plane (TAP) Block Group

ACTIVE COMPARATOR

Intervention - At the end of surgery Ultrasound guided Transversus Abdominis Plane block was given with 20 ml 0.25 % bupivacaine bolus and repeated every 8 hourly upto 24 hours.

Drug: Bupivacaine (Transversus Abdominis Plane Block)

Control Group (No TAP Block)

PLACEBO COMPARATOR

The Transversus Abdominis Plane Block was not performed. Intravenous PCA Morphine was given as rescue analgesic upto 24 hours.

Drug: Intravenous Patient Controlled Analgesia (PCA) Morphine

Interventions

Bupivacaine (Transversus Abdominis Plane Block) DRUG

Intervention - At the end of surgery Ultrasound guided Transversus Abdominis Plane block was given with 20 ml 0.25 % bupivacaine bolus and repeated every 8 hourly up to 24 hours.

Transversus Abdominis Plane (TAP) Block Group

Intravenous Patient Controlled Analgesia (PCA) Morphine DRUG

PCA Intravenous Morphine 1 milligram bolus on demand was given as rescue analgesia up to 24 hours.

Control Group (No TAP Block)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients belonging to American Society of Anesthesiologist (ASA) Physical Status I to III, for Open lower abdominal major onco surgeries more than 2 hours duration.

You may not qualify if:

• Patient refusal to participate in the study, allergy to local anesthetics, coagulopathy, local skin infection at the site of TAP Block.

Sponsors & Collaborators

• Rajiv Gandhi Cancer Institute & Research Center, India: lead

Related Publications (2)

• Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.

  PMID: 19020158 RESULT

• McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.

  PMID: 17179269 RESULT

MeSH Terms

Conditions

Bites and Stings

Interventions

Bupivacaine; Analgesia, Patient-Controlled; Passive Cutaneous Anaphylaxis; Morphine

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Analgesia; Anesthesia and Analgesia; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Anita Kulkarni, MD

  Rajiv Gandhi Cancer Institute and Research Centre , Delhi , India 110085

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 24, 2017
• Study Start: February 11, 2013
• Primary Completion: July 10, 2014
• Study Completion: August 20, 2014
• Last Updated: May 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share