Oblique Subcostal Tap Block Efficacy in Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-06-30

Brief Summary

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Laparoscopic cholecystectomy although a minimally invasive procedure, may be accompanied by considerable pain after surgery. More recently transversus abdominis plane (TAP) block was extensively studied as a potential analgesic maneuver after laparoscopic cholecystectomy. The subcostal approach (OSTAP block) is a variation on the TAP block that produces reliable supraumbilical analgesia.

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Detailed Description

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Laparoscopic cholecystectomy is a minimally invasive widespread surgical procedure, with postoperative lower pain scores and quick recovery of the patient. However some of patients may complain of considerable pain after surgery . There are several approaches to postoperative pain management after laparoscopic cholecystectomy such as patient-controlled analgesia with opioids (IV-PCA), neuraxial blocks, intraperitoneal injection of local anesthetics, wound infiltration, each being more or less effective, with specific side effects.

The transversus abdominis plane block (TAP-Block) is a regional analgesia technique that comes as an alternative to "classical" procedures of postoperative analgesia. Described by Rafi and McDonnell et al. this technique has undergone some changes over times, which increased its efficiency. Thus, Hebbard et al. described ultrasound subcostal oblique approach (OSTAP) of the block allowing analgesia in both the upper and lower abdomen, with a lower rate of complications due to the direct ultrasound visualization. Different studies confirmed the analgesic efficacy of this technique and the postoperative opioid sparing effect after laparoscopic cholecystectomy .

Traditionally, the transversus abdominis plane block is achieved with classical amino-amides local anesthetics, bupivacaine, levobupivacaine and ropivacaine being the most commonly used .

Based on the local anesthetic properties of pethidine, a synthetic opioid, our study aimed to evaluate prospectively the analgesic efficacy of pethidine in achieving transversus abdominis plane block by ultrasound oblique subcostal approach in patients scheduled for elective laparoscopic cholecystectomy.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Placebo

Oblique subcostal tap block with normal sterile saline ,20 ml, bilateral, single shot,24h

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tap Block performed with normal sterile saline 20 ml on the right side and 20 ml on the left side

Bupivacaine

Oblique subcostal tap block with bupivacaine 0,25% ,20 ml, bilateral, single shot,24h

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Tap Block performed with Bupivacaine 0,25% 20 ml on the right side and 20 ml on the left side.

Pethidine

Oblique subcostal tap block with pethidine 1% ,10 ml,bilateral,single shot,24h

Group Type ACTIVE_COMPARATOR

Pethidine

Intervention Type DRUG

Tap Block performed with pethidine 1% 10 ml on the right side and 10 ml on the left side

Pethidine Local Infiltration (L.I.)

Local infiltration of pethidine 1% at trocar insertion sites, 5ml /site, 24h compared with Tap Block with pethidine 1%

Group Type ACTIVE_COMPARATOR

Pethidine Local Infiltration (L.I)

Intervention Type DRUG

Local infiltration of port sites (trocar insertion sites) with pethidine 1% 5ml each port (trocar site) ,4 ports total 20 ml pethidine 1%

Interventions

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Placebo

Tap Block performed with normal sterile saline 20 ml on the right side and 20 ml on the left side

Intervention Type DRUG

Bupivacaine

Tap Block performed with Bupivacaine 0,25% 20 ml on the right side and 20 ml on the left side.

Intervention Type DRUG

Pethidine

Tap Block performed with pethidine 1% 10 ml on the right side and 10 ml on the left side

Intervention Type DRUG

Pethidine Local Infiltration (L.I)

Local infiltration of port sites (trocar insertion sites) with pethidine 1% 5ml each port (trocar site) ,4 ports total 20 ml pethidine 1%

Intervention Type DRUG

Other Intervention Names

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Tap Block Placebo Tap Block Bupivacaine Tap Block Pethidine Pethidine Local Infiltration

Eligibility Criteria

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Inclusion Criteria

* American Society of Anaesthesiologists (ASA) I-II
* Age over 18years old
* patients scheduled elective laparoscopic cholecystectomy

Exclusion Criteria

* Open cholecystectomy - excluded due to increased levels of pain in open procedures
* Renal dysfunction (Serum Cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
* Coagulopathy or anticoagulation - increased risk of bleeding from nerve block injection
* Allergy or contraindication to any of the study medications or anesthetic agents
* Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
* Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
* Pregnancy
* Prisoners
* Patient or surgeon refusal

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No