TAP Block Versus Conventional Systemic Analgesia

Analgesia Clinical Trial

— TAPLAP  

Official title:

TAP Block Versus Conventional Systemic Analgesia in Laparoscopic Surgery: A Prospective Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06058715
• Other study ID #: TAP1-LAP2
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: October 2024

Study information

• Verified date: September 2023
• Source: Ministry of Scientific Research, Tunisia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare TAP block to conventional systemic analgesia for postoperative pain management in patients undergoing elective laparoscopic cholecystectomy. As the adverse effects of pain management is related to size of opioid dose use, opioid consumption is chosen as the primary outcome and a decrease of at least 20% in the TAP block compared with the conventional systemic analgesia is considered to be clinically significant.

Written informed consent has to obtained from all study patients. This trial is a prospective parallel group randomized superiority trial comparing TAP block to classic systemic analgesia in patients undergoing elective laparoscopic surgery in the department of surgery, Mahmoud El Matri Hospital, Ariana, with a 1:1 allocation ratio.

Description:

Laparoscopic cholecystectomy constitutes a routinely performed procedure world-wide. Analgesia accounts for one of the major keys for success especially in enhanced recovery after surgery pathway and ambulatory surgery. Hence, controlling opioid consumption used in conventional systemic analgesia is mandatory while reliving pain. The TAP block is integrated within a multimodal analgesia. It corresponds to a locoregional analgesia.

The goal of this clinical trial is to compare TAP block to conventional systemic analgesia for postoperative pain management in patients undergoing elective laparoscopic cholecystectomy. As the adverse effects of pain management is related to size of opioid dose use, opioid consumption is chosen as the primary outcome and a decrease of at least 20% in the TAP block compared with the conventional systemic analgesia is considered to be clinically significant.

Written informed consent has to obtained from all study patients. This trial is a prospective parallel group randomized superiority trial comparing TAP block to classic systemic analgesia in patients undergoing elective laparoscopic surgery in the department of surgery, Mahmoud El Matri Hospital, Ariana, with a 1:1 allocation ratio.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 380
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All patients scheduled for elective laparoscopic cholecystectomy at the department of surgery, Mahmoud El Matri Hospital, Ariana

Exclusion Criteria:

• Severe renal insufficiency (GFR < 30 ml/min)

• Severe hepatic insufficiency (TT = 50%)

• Severe COPD (FEV1 > 30%)

• Metastatic malignancy

• Hematologic disease or a congenital clotting disorder

• Preoperative opioid use

• Age under 18 years

• Pregnancy or breast-feeding

• Hyper-reactivity toward ropivacaine

• Estimated risk for conversion to open surgery > 50%

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• Transverse Abdominal Plan block (TAP block)
Bilateral TAP block is administered intraoperatively at laparoscopy, directly after insufflation and insertion of the first trocar and camera. The ultrasound probe is placed longitudinally on the midaxillary line near umbilicus, and the transversus abdominis and internal oblique muscles are scanned and observed. The needle (22-gauge 90 mm disposable spinal needle) is inserted in plane and after placing the needle-tip into the fascia between transversus abdominis and internal oblique muscles, 20 ml of ropivacaine 0.25% is injected bilaterally. It is all done by one Anesthetist which is expert in that area and is not in charge of collecting the data.

Locations

Country	Name	City	State
Tunisia	Department of surgery, Mahmoud El Matri hospital, Ariana, Tunisia	Ariana

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Scientific Research, Tunisia

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption during the first 48 h postoperatively.	Opioids are given only on request based on pain numerical rating scale (pain NRS) varying from 0 to10. For pain NRS > 3 at rest or for pain NRS > 5 on exercise, oxycodone is administrated intravenously at the recovery room at the dose of 0.05 mg/kg. Then, it is used intramuscularly at the dose of 0.1 mg/kg up to 24 hours after surgery and orally at the dose of 0.15 mg/kg between 24 and 48 hours after surgery.; At 2 to 4 weeks postoperatively, all patients are contacted either by phone or at the outpatient clinic during a follow-up visit and asked to complete a form with questions evaluating pain sensations, pain intensity, need for pain medication, performance of daily activities, and any limitations of these due to postoperative abdominal pain.	Every six hours
Secondary	Pain intensity on a numerical rating scale (pain NRS, 0-10)	pain intensity is measured 30 min after arrival and then every hour until the patient is discharged to the ward. In the ward, the pain NRS score is measured for each consecutive 6-h block. Means of the first and second 6-h blocks and third and fourth blocks are calculated and used for further analysis. Additionally, the maximal daily pain NRS scores are collected. At the time of discharge, patients evaluate their satisfaction with pain management as a whole (scale 0-3: 0 poor; 3 excellent).	Every six hours
Secondary	Postoperative evaluation at 4 weeks	At 4 weeks postoperatively, all patients are contacted either by phone and asked to complete a form with questions evaluating pain sensations, pain intensity, need for pain medication, performance of daily activities, and any limitations of these due to postoperative abdominal pain.	At 4 weeks after surgery