Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03856788
Other study ID # GCO 18-1886
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 10, 2018
Est. completion date March 25, 2021

Study information

Verified date September 2022
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study team will be assessing if the unilateral subcostal transversus abdominis plane (TAP) block can decrease pain and improve outcomes following laparoscopic sleeve gastrectomy surgeries.


Description:

This study will be a double-blinded randomized control trial. Patients will be randomized into one of two groups. Patients in Group 1 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL 0.25% bupivacaine on the ipsilateral side as the extraction site. Patients in Group 2 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL sterile normal saline on the ipsilateral side as the extraction site. Investigators will be blinded to the randomization of these patients. Following performance of these blocks, patients will receive standard care for the surgery as well as during the postoperative recovery period. Data will be obtained from the EPIC electronic medical record, and from the anesthesia computer record. Patients will be asked postoperatively to assess items such as their nausea and pain scores. Patients will also be contacted by phone within 1-2 days of discharge to obtain analgesic satisfaction scores. This data will be collected on the Redcap server.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date March 25, 2021
Est. primary completion date March 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Adults 18-80 years old - Candidate for general anesthesia - Undergoing laparoscopic sleeve gastrectomy - Patients of participating surgeons Exclusion Criteria: - Prior bariatric surgery of any kind - Previous abdominoplasty - Allergy or intolerance to one of the study medications - ASA > 4 - Chronic opioid use (taking opioids for longer than 3 months or daily oral morphine equivalent of >5mg/day for one month) - History of alcohol/drug abuse - History of hepatic or renal insufficiency - Patient refusal

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Saline
40 mL sterile normal saline
Bupivacaine
40 mL 0.25% bupivacaine

Locations

Country Name City State
United States Mount Sinai Brooklyn New York New York

Sponsors (1)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (10)

Abdelsalam K, Mohamdin OW. Ultrasound-guided rectus sheath and transversus abdominis plane blocks for perioperative analgesia in upper abdominal surgery: A randomized controlled study. Saudi J Anaesth. 2016 Jan-Mar;10(1):25-8. doi: 10.4103/1658-354X.169470. — View Citation

Ari DE, Ar AY, Karip CS, Köksal C, Aydin MT, Gazi M, Akgün F. Ultrasound-guided subcostal-posterior transversus abdominis plane block for pain control following laparoscopic sleeve gastrectomy. Saudi Med J. 2017 Dec;38(12):1224-1229. doi: 10.15537/smj.2017.12.21133. — View Citation

Cho JS, Kim HI, Lee KY, Son T, Bai SJ, Choi H, Yoo YC. Comparison of the effects of patient-controlled epidural and intravenous analgesia on postoperative bowel function after laparoscopic gastrectomy: a prospective randomized study. Surg Endosc. 2017 Nov;31(11):4688-4696. doi: 10.1007/s00464-017-5537-6. Epub 2017 Apr 7. — View Citation

Lee TH, Barrington MJ, Tran TM, Wong D, Hebbard PD. Comparison of extent of sensory block following posterior and subcostal approaches to ultrasound-guided transversus abdominis plane block. Anaesth Intensive Care. 2010 May;38(3):452-60. — View Citation

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. Erratum in: Anesth Analg. 2007 May;104(5):1108. — View Citation

Moncada R, Martinaitis L, Landecho M, Rotellar F, Sanchez-Justicia C, Bellver M, de la Higuera M, Silva C, Osés B, Martín E, Pérez S, Hernandez-Lizoain JL, Frühbeck G, Valentí V. Does Preincisional Infiltration with Bupivacaine Reduce Postoperative Pain in Laparoscopic Bariatric Surgery? Obes Surg. 2016 Feb;26(2):282-8. doi: 10.1007/s11695-015-1761-0. — View Citation

Ruiz-Tovar J, Muñoz JL, Gonzalez J, Zubiaga L, García A, Jimenez M, Ferrigni C, Durán M. Postoperative pain after laparoscopic sleeve gastrectomy: comparison of three analgesic schemes (isolated intravenous analgesia, epidural analgesia associated with intravenous analgesia and port-sites infiltration with bupivacaine associated with intravenous analgesia). Surg Endosc. 2017 Jan;31(1):231-236. doi: 10.1007/s00464-016-4961-3. Epub 2016 May 13. — View Citation

Shibata Y, Sato Y, Fujiwara Y, Komatsu T. Transversus abdominis plane block. Anesth Analg. 2007 Sep;105(3):883; author reply 883. — View Citation

Thorell A, MacCormick AD, Awad S, Reynolds N, Roulin D, Demartines N, Vignaud M, Alvarez A, Singh PM, Lobo DN. Guidelines for Perioperative Care in Bariatric Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations. World J Surg. 2016 Sep;40(9):2065-83. doi: 10.1007/s00268-016-3492-3. Review. — View Citation

Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Amount of 24 Hour Opioid Consumption Amount of intravenous (IV) opioid consumption within 24-hour period 24 Hours postoperative
Secondary Amount of Intraoperative IV Opioid Consumption Amount of intravenous opioid consumption during the surgery average 2-3 Hours
Secondary Number of Participants Asked Area of Pain on the Body After Surgery Patients asked for the areas of pain (right upper quadrant (RUQ), left upper quadrant, (LUQ) right lower quadrant (RLQ), or left lower quadrant (LLQ), diffuse and epigastric) after surgery. 24 Hours postoperative
Secondary Number of Participants Who Answered Yes to Having Presence of Nausea After Surgery Number of participants who answered yes to having presence of nausea after surgery 24 Hours postoperative
See also
  Status Clinical Trial Phase
Withdrawn NCT04771247 - Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy N/A
Not yet recruiting NCT05485363 - Non-invasive Assessment of Intracranial Pressure Using Ocular Sonography in Patients Undergoing Laparoscopic Sleeve Gastrectomy N/A
Terminated NCT02762487 - RELIEF Europe Study N/A
Withdrawn NCT02008409 - Evaluation of Safety and Efficacy of the EndoLift Liver Retractor N/A
Completed NCT06052111 - Dexmedetomidine vs Fentanyl on Time to Extubation in Patients Undergoing Laparoscopic Sleeve Gastrectomy N/A
Completed NCT06284356 - Pan Immune Inflammation Value for Perioperative Complications of Laparoscopic Sleeve Gastrectomy
Recruiting NCT06305221 - Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Receiving Laparoscopic Sleeve Gastrectomy N/A
Active, not recruiting NCT05873270 - Randomized, Controlled, Single-blind Exploratory Study of the Efficacy and Safety of Wrist and Ankle Acupuncture Intervention on Nausea, Vomiting and Pain After Sleeve Gastric Surgery in Women
Completed NCT03051919 - Reinforcement Method in Laparoscopic Sleeve Gastrectomy N/A
Withdrawn NCT04452786 - Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty N/A
Recruiting NCT05224791 - A Retrospective Multicenter Comparison of Laparoscopic and Robotic-Assisted Roux-en-Y Gastrectomy
Completed NCT04264364 - ESG vs LSG: Short-term Nutritional Outcomes
Completed NCT03629808 - Laparoscopic Sleeve Gastrectomy: a Cohort Study
Not yet recruiting NCT06425016 - Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy N/A
Not yet recruiting NCT04323696 - Comparison of Staple Line Suturing in Laparoscopic Sleeve Gastrectomy N/A
Not yet recruiting NCT04442568 - Impact of ERAS in LSG N/A
Completed NCT06423846 - Total Intravenous Anesthesia Versus Inhalation Anesthesia on Postoperative Liver Function N/A
Recruiting NCT04151459 - Effect of Metabolic Surgery on Live Birth Rate of Offspring in Obesity Polycystic Ovarian Syndrome Patients N/A
Completed NCT04439851 - Impact of Sleeve Gastrectomy on Monocyte-to-High-Density Lipoprotein Cholesterol Ratio
Completed NCT03435003 - Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy Phase 4

External Links