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Analgesic Effect of Subcostal TAP Block

Not Applicable
Completed
Conditions
Subcostal TAP Block for Multiport Laparoscopic Cholecystectomy
Interventions
Procedure: Ultrasound guided bilateral subcostal TAP block
Procedure: Ultrasound guided bilateral posterior TAP block
Registration Number
NCT02708017
Lead Sponsor
Aga Khan University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
70
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
S-TAP blockUltrasound guided bilateral subcostal TAP blockultrasound guided bilateral subcostal TAP block
P-TAP blockUltrasound guided bilateral posterior TAP blockultrasound guided bilateral Posterior TAP block
Primary Outcome Measures
NameTimeMethod
Mean postoperative static and dynamic numeric rating scale (NRS) at 24 hours24 hours

To compare the mean NRS at 0hr, 1hr, 2 hrs. 6 hrs. 12 hrs. and 24hrs. post-operatively between two groups Numeric rating scale for pain,(0=no pain, 1-3= mild pain, 4-6 moderate pain, 7-10 severe pain.)

Secondary Outcome Measures
NameTimeMethod
Mean opioid consumption postoperatively24hours

To compare post-operative mean opioid consumption in the two groups

Nausea , vomiting and sedation score24 hours

To compare mean post-operative nausea, vomiting and sedation scores between the two groups.

Nausea score (none = 0; mild = 1(requiring no medication); moderate = 2(requiring anti-emetics); severe = 3(unresponsive to anti-emetics) Sedation score (awake and alert =0; quietly awake = 1; asleep but easily roused = 2; deep sleep =3)

Surgical outcome24 hours

To compare surgical outcomes in terms of early mobilization out of bed,intake of first postoperative meal,and early discharge after 24 hours of surgery between the two groups

Patient satisfaction24hours

patient satisfaction is assessed by using a questionnaire at 24hours

1. Are you satisfied with the method of your pain relief? Yes / No

2. Would you recommend the same method of pain relief to your family/friends? Yes / No

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