Effect of TAP Block on Stress Hormones

NCT03443271 | Completed Phase 4 DMC

• 1 other identifier: 4718-Ane-ERC-17
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Abdominal Hysterectomy; Postoperative Pain

Keywords

transversus abdominis plane block; abdominal hysterectomy; stress response

Outcome Measures

Primary Outcomes (2)

• Serum Cortisol

  Serum cortisol measured in µg/dL

  12 hours after surgery

• Serum Norepinephrine

  Serum norepinephrine levels in pg/ml

  12 hours after surgery

Secondary Outcomes (4)

• Pain Score

  12 hours after surgery

• Rescue analgesia

  12 hours after surgery

• Total amount of opioid consumption

  12 hours after surgery

• Side effects

  12 hours after surgery

Other Outcomes (1)

• Patient satisfaction

  24 hours after surgery

Study Arms (2)

Group T (TAP Block with Bupivicaine)

EXPERIMENTAL

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

Group C (TAP Block with Placebo drug)

PLACEBO COMPARATOR

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

Interventions

TAP Block with Bupivicaine PROCEDURE

Ultrasound guided TAP block will be performed and patient will be administered 20 ml of 0.25 % Bupivicaine on each side.

Group T (TAP Block with Bupivicaine)

TAP Block with Placebo drug PROCEDURE

Ultrasound guided TAP block will be performed and patient will be administered 20 ml of 0.9% Saline on each side.

Group C (TAP Block with Placebo drug)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for elective TAH via Pfannenstiel abdominal wall incision under general anaesthesia
• American Society of Anesthesiologists physical status I-II

You may not qualify if:

• Patients will be excluded if there is patient refusal to participate in the study, history of relevant drug allergy, or medical therapies considered to result in tolerance to opioids, hysterectomy performed for malignancy or inability to use patient control analgesia (PCA) devise

Sponsors & Collaborators

• Aga Khan University: lead

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MeSH Terms

Conditions

Pain, Postoperative; Fractures, Stress

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Fractures, Bone; Wounds and Injuries

Study Officials

• Samina Ismail

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective double blind randomized control trial

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 23, 2018
• Study Start: June 17, 2016
• Primary Completion: September 19, 2017
• Study Completion: September 20, 2017
• Last Updated: February 23, 2018

Record last verified: 2018-02