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

NCT ID: NCT03165383

Last Updated: 2017-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-11
• Study Completion Date: 2014-08-20

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.

Detailed Description

Adult patients of both sexes undergoing major lower abdominal cancer surgeries were enrolled in the study. After obtaining written informed consent from all the patients, they were randomly allotted to either Study (TAP) Group or Control group. Standard general anesthesia with endotracheal intubation was performed in all the patients. Preoperatively all patients received information about Visual Analogue Scale (VAS) for Pain Score from 1 to 10 depending on intensity of pain and about the use of Patient Controlled Analgesia (PCA) Pump. After the end of surgery and before extubation bilateral Ultrasound guided Transversus Abdominis Plane (TAP) block was performed with 16 G Tuohy needle and 18 G Braun Perifix epidural catheter was placed about 6-8 cms in situ. Bupivacaine 0.25 % 20 ml was given bilaterally and repeated 8 hourly in the Postoperative Anaesthesia Care Unit (PACU) for first 24 hours. The PCA Pump was set to deliver bolus Intravenous Morphine 1 milligram ( mg ) with lock out interval 10 minutes. In the PACU heart rate, Non invasive blood pressure, Visual Analogue Score at rest and on knee flexion, Sedation score, nausea and vomiting, any side effects as itching was noted by care provider at 0, 2, 4, 6, 12, 18 and 24 hours. Total and good PCA demands upto 24 hours was recorded.

Conditions

Abdominal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transversus Abdominis Plane (TAP) Block Group

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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine (Transversus Abdominis Plane Block)

Intervention Type: 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.

Control Group (No TAP Block)

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

Group Type: PLACEBO_COMPARATOR

Intravenous Patient Controlled Analgesia (PCA) Morphine

Intervention Type: DRUG

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

Interventions

Bupivacaine (Transversus Abdominis Plane Block)

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.

Intervention Type: DRUG

Intravenous Patient Controlled Analgesia (PCA) Morphine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rajiv Gandhi Cancer Institute & Research Center, India

OTHER

Sponsor Role: lead

Responsible Party

Dr Anita Kulkarni

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anita Kulkarni, MD

Role: PRINCIPAL_INVESTIGATOR

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

References

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.

Reference Type: RESULT

PMID: 19020158 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17179269 (View on PubMed)

Other Identifiers

RGCI & RC

Identifier Type: -

Identifier Source: org_study_id