Analgesic Effect of Subcostal TAP Block

NCT ID: NCT02708017

Last Updated: 2016-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-09-30

Brief Summary

The purpose of this study was to compare the analgesic efficacy of the ultrasound guided bilateral subcostal tap block with ultrasound guided bilateral posterior tap block for postoperative analgesia after laparoscopic cholecystectomy

Detailed Description

After approval from Ethics Review Committee, patients were enrolled according to the inclusion and exclusion criteria. Informed written consent for inclusion in the study was taken and during the process,patients were explained about the NRS and other secondary objectives.

Blocks were performed under ultrasound guidance immediately after induction of anesthesia.For postoperative analgesia,patients were randomly allocated in two groups using draw/ballot method assigning patients to either of the S-TAP block group or P-TAP-block group. The patients and the staff providing postoperative care and the doctor assessing the pain after surgery were blinded to group assignment. Patients in both groups received standard of care analgesia during the post-operative period i.e., I/V Ketorolac 30mg every 8 hourly, I/V Tramadol 50mg every 8hourly and as per need basis, and I/V Paracetamol 1000mg every 6 hourly Subsequent surgical procedure was performed routinely. After completion of the surgery and emergence from anesthesia, patients were shifted to the Post Anaesthesia Care Unit, and time of arrival in recovery room was taken as 0-hour and noted. Assessment for outcome measures started in recovery room, and continued till 24 hours of the surgery.

Conditions

Subcostal TAP Block for Multiport Laparoscopic Cholecystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: TRIPLE

Study Groups

S-TAP block

ultrasound guided bilateral subcostal TAP block

Group Type: ACTIVE_COMPARATOR

Ultrasound guided bilateral subcostal TAP block

Intervention Type: PROCEDURE

ultrasound guided bilateral subcostal TAP block was performed after induction of general anaesthesia.after all aseptic measures,abdomen was prepared with antiseptic spray,with the help of portable ultrasound machine using probe frequency of 11 Mega Hertz,ultrasound probe was positioned parallel to the costal margin near the midline,the rectus abdominis muscle was identified ,probe was gradually moved laterally and obliquely along the subcostal margin and the transversus abdominis muscle identified lying posterior to the rectus muscle.the 20Gauge,100millimeter long needle was introduced at the lateral edge of the rectus muscle ,from medial to lateral,in plane of the ultrasound beam.After confirmation of the plane with saline, 20ml of 0.375% solution of bupivacaine was injected on each side of the abdomen.

P-TAP block

ultrasound guided bilateral Posterior TAP block

Group Type: ACTIVE_COMPARATOR

Ultrasound guided bilateral posterior TAP block

Intervention Type: PROCEDURE

ultrasound guided bilateral posterior TAP block was performed after induction of general anaesthesia.after all aseptic measures,abdomen was prepared with antiseptic spray.with the help of portable ultrasound machine using probe frequency of 11Mega Hertz,ultrasound probe was positioned transversely to the abdominal wall in the midaxillary line between the iliac crest and coastal margin,and carefully moved posteriolaterally for optimal identification of plane.the 20G,100mm long needle was introduced anteriorly and in line with the probe,from medial to lateral,and advanced until it reached the fascial plane between the internal oblique and transversus abdominis muscle.upon reaching the plane ,20ml of 0.375% solution of bupivacaine was injected on each side of the abdomen.

Interventions

Ultrasound guided bilateral subcostal TAP block

ultrasound guided bilateral subcostal TAP block was performed after induction of general anaesthesia.after all aseptic measures,abdomen was prepared with antiseptic spray,with the help of portable ultrasound machine using probe frequency of 11 Mega Hertz,ultrasound probe was positioned parallel to the costal margin near the midline,the rectus abdominis muscle was identified ,probe was gradually moved laterally and obliquely along the subcostal margin and the transversus abdominis muscle identified lying posterior to the rectus muscle.the 20Gauge,100millimeter long needle was introduced at the lateral edge of the rectus muscle ,from medial to lateral,in plane of the ultrasound beam.After confirmation of the plane with saline, 20ml of 0.375% solution of bupivacaine was injected on each side of the abdomen.

Intervention Type: PROCEDURE

Ultrasound guided bilateral posterior TAP block

ultrasound guided bilateral posterior TAP block was performed after induction of general anaesthesia.after all aseptic measures,abdomen was prepared with antiseptic spray.with the help of portable ultrasound machine using probe frequency of 11Mega Hertz,ultrasound probe was positioned transversely to the abdominal wall in the midaxillary line between the iliac crest and coastal margin,and carefully moved posteriolaterally for optimal identification of plane.the 20G,100mm long needle was introduced anteriorly and in line with the probe,from medial to lateral,and advanced until it reached the fascial plane between the internal oblique and transversus abdominis muscle.upon reaching the plane ,20ml of 0.375% solution of bupivacaine was injected on each side of the abdomen.

Intervention Type: PROCEDURE

Other Intervention Names

S-TAP Block; P-TAP Block

Eligibility Criteria

Inclusion Criteria

• Patients age 18 to 60 years,American society of Anaesthesiology(ASA) class I and II, admitted electively for laparoscopic cholecystectomy

Exclusion Criteria

• Patients with known allergies to local anesthetics, who were morbidly obese because of difficulty of ultrasound guided approaches for block or having hepato-splenomegaly or any known liver disease, and those whose laparoscopic procedure is converted to open cholecystectomy for any reason

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

DR.Karima karam khan

Dr.Karima karam khan

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karima K Khan, FCPS

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Other Identifiers

2317-ane-ERC-12

Identifier Type: -

Identifier Source: org_study_id