Effect of TAP Block on Stress Hormones
|ClinicalTrials.gov Identifier: NCT03443271|
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Random allocation of patients in two groups; Tap block group (T group) and control group (C group). All patients will receive standard general anesthesia and postoperative pain management. The TAP group patient will receive ultrasound guided (US) TAP block with 20 cc of 0.25% of bupivacaine and control group will receive 20cc of normal saline. TAP block in both groups will be performed with US guidance and the study drug will be injected after complete visualization of the needle tip between the internal oblique and the transversus abdominis muscles.
Venous blood samples (5 ml for each time) for metabolic and stress hormones, including, Serum cortisol and nor-epinephrine will be collected before anesthesia at the time of cannulation (T1),60 minutes after incision(T2), 6hrs (T3)and 12 h (T4) after the surgery.
Postoperatively patient will be put on patient controlled intravenous infusion of nalbuphine
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Hysterectomy Postoperative Pain||Procedure: TAP Block with Bupivicaine Procedure: TAP Block with Placebo drug||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective double blind randomized control trial|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Patients will be randomly allocated in equal groups of 25 each to undergo TAP block (T group) with 20ml of 0.25% bupivacaine per side or TAP block with 20 ml of normal saline on both sides, which will be the control group (C group). The allocation sequence will be generated by a random number table, and group allocation will be concealed in sealed, opaque envelopes, which will not be opened until patient consent will be obtained. The process of randomization and blinding will be done by the clinical trial unit and according to the group allocation; pre-formed sterile syringes will be dispensed by the clinical trial unit to anesthesiologist performing the TAP block. The anesthesiologist performing the TAP block, patients and staff providing postoperative care will be blinded to group assignment.|
|Official Title:||Effect of Transversus Abdominis Plane (TAP) Block and the Perioperative Stress Response: Randomized Control Trial in Patient Undergoing Total Abdominal Hysterectomy in a Tertiary Care Hospital of Pakistan|
|Actual Study Start Date :||June 17, 2016|
|Actual Primary Completion Date :||September 19, 2017|
|Actual Study Completion Date :||September 20, 2017|
Experimental: Group T (TAP Block with Bupivicaine)
Ultrasound guided TAP block will be performed in this group. Bupivicaine 0.25 % 20 ml will be administered in the block on either side.
Procedure: TAP Block with Bupivicaine
Ultrasound guided TAP block will be performed and patient will be administered 20 ml of 0.25 % Bupivicaine on each side.
Placebo Comparator: Group C (TAP Block with Placebo drug)
Ultrasound guided TAP block will be performed in this group. 0.9 % Saline 20 ml will be administered in the block on either side.
Procedure: TAP Block with Placebo drug
Ultrasound guided TAP block will be performed and patient will be administered 20 ml of 0.9% Saline on each side.
- Serum Cortisol [ Time Frame: 12 hours after surgery ]Serum cortisol measured in µg/dL
- Serum Norepinephrine [ Time Frame: 12 hours after surgery ]Serum norepinephrine levels in pg/ml
- Pain Score [ Time Frame: 12 hours after surgery ]Pain will be measure by a Numeric Rating Score at rest and on movement. Numeric Rating Score will be from 1 to 10 where 1 is no pain and 10 is the most severe pain
- Rescue analgesia [ Time Frame: 12 hours after surgery ]Number of times rescue analgesia was required
- Total amount of opioid consumption [ Time Frame: 12 hours after surgery ]Total consumption in milligrams from Patient controlled intravenous analgesia machine
- Side effects [ Time Frame: 12 hours after surgery ]Nausea, Vomiting and sedation
- Patient satisfaction [ Time Frame: 24 hours after surgery ]7-point Likert scale (1=strongly disagree, 7=strong¬ly agree)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443271
|Principal Investigator:||Samina Ismail||Aga Khan University|